Trial Outcomes & Findings for A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors (NCT NCT03708328)

Last Updated: 2025-08-20

Results Overview

A DLT was defined as a clinically significant adverse event (AE) or significant laboratory abnormality: 1) occurring during DLT assessment period of 21 days; 2) considered to be related to study treatment RO7121661 by the Investigator; 3) is not attributed to disease progression or another clearly identifiable cause. Following AEs were considered DLTs: Hematological toxicities (Grade 4 neutropenia lasting \>5 days, Grade ≥3 febrile neutropenia, Grade 4 thrombocytopenia lasting \> 48 hours, Grade 3 thrombocytopenia associated with bleeding episodes, Grade 4 anemia, Grade ≥3 anemia with hemolysis); Non-hematological toxicity Grade ≥3 (Any Grade 3 immune-mediated AE, Grade 3 hyperbilirubinemia lasting for \>48 hours/Grade 4 hyperbilirubinemia; Grade ≥3 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations with hyperbilirubinemia of Grade ≥2, Grade 4 AST or ALT elevations, Grade ≥3 nausea, vomiting, or diarrhea, Grade ≥3 non-hematological laboratory abnormality.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

134 participants

Primary outcome timeframe

From Cycle 1 Day 1 to Cycle 2 Day 7 (Cycle length= 14 days)

Results posted on

2025-08-20

Participant Flow

A total of 134 participants with advanced and/or metastatic solid tumors took part in the study across 17 investigative sites in Spain, France, Republic of Korea, Denmark, United States and New Zealand from 15 October 2018 to 09 July 2024.

This study was conducted in two parts: Part A (Dose Escalation) and Part B (Tumor-Specific Expansion Cohorts). Part B included the Cohorts B1, B2, B4, and B5, enrolling participants with selected tumor types. Part B3 was not initiated.

Participant milestones

Participant milestones
Measure	Part A: Lomvastomig 70 mg Participants received 70 milligrams (mg) of lomvastomig, as an intravenous (IV) infusion on Cycle 1 Day 1 and every two weeks (Q2W) thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve SCLC with prior failure of, progression on, or intolerance to standard therapy received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve ESCC received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Overall Study STARTED	3	5	4	4	4	19	38	26	15	16
Overall Study COMPLETED	0	1	0	1	1	1	7	2	0	2
Overall Study NOT COMPLETED	3	4	4	3	3	18	31	24	15	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Lomvastomig 70 mg Participants received 70 milligrams (mg) of lomvastomig, as an intravenous (IV) infusion on Cycle 1 Day 1 and every two weeks (Q2W) thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve SCLC with prior failure of, progression on, or intolerance to standard therapy received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve ESCC received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Overall Study Death	3	3	4	2	2	13	26	18	13	8
Overall Study Lost to Follow-up	0	1	0	1	0	3	3	0	0	1
Overall Study Physician Decision	0	0	0	0	0	1	0	0	0	0
Overall Study Withdrawal by Subject	0	0	0	0	1	0	2	4	1	5
Overall Study Study Closed Locally	0	0	0	0	0	0	0	1	0	0
Overall Study Study Ended By Sponsor	0	0	0	0	0	1	0	1	0	0
Overall Study Participant Was Alive, Did Not Return to Hospital	0	0	0	0	0	0	0	0	1	0

Baseline Characteristics

A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=19 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort n=38 Participants Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 n=26 Participants Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=15 Participants Participants with CPI-naïve SCLC with prior failure of, progression on, or intolerance to standard therapy received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=16 Participants Participants with CPI-naïve ESCC received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Total n=134 Participants Total of all reporting groups
Age, Continuous	56.3 years STANDARD_DEVIATION 9.3 • n=5 Participants	59.6 years STANDARD_DEVIATION 13.9 • n=7 Participants	61.0 years STANDARD_DEVIATION 2.4 • n=5 Participants	53.8 years STANDARD_DEVIATION 7.1 • n=4 Participants	53.5 years STANDARD_DEVIATION 15.8 • n=21 Participants	60.9 years STANDARD_DEVIATION 8.8 • n=8 Participants	61.1 years STANDARD_DEVIATION 12.1 • n=8 Participants	62.3 years STANDARD_DEVIATION 9.7 • n=24 Participants	60.3 years STANDARD_DEVIATION 9.2 • n=42 Participants	61.1 years STANDARD_DEVIATION 10.6 • n=42 Participants	60.6 years STANDARD_DEVIATION 10.4 • n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	9 Participants n=8 Participants	17 Participants n=8 Participants	11 Participants n=24 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants	49 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	10 Participants n=8 Participants	21 Participants n=8 Participants	15 Participants n=24 Participants	14 Participants n=42 Participants	12 Participants n=42 Participants	85 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	5 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	17 Participants n=8 Participants	28 Participants n=8 Participants	20 Participants n=24 Participants	15 Participants n=42 Participants	8 Participants n=42 Participants	104 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	9 Participants n=8 Participants	6 Participants n=24 Participants	0 Participants n=42 Participants	8 Participants n=42 Participants	25 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	8 Participants n=24 Participants	2 Participants n=42 Participants	6 Participants n=42 Participants	20 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	18 Participants n=8 Participants	28 Participants n=8 Participants	14 Participants n=24 Participants	13 Participants n=42 Participants	4 Participants n=42 Participants	97 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	7 Participants n=8 Participants	3 Participants n=24 Participants	0 Participants n=42 Participants	6 Participants n=42 Participants	16 Participants n=42 Participants

PRIMARY outcome

Timeframe: From Cycle 1 Day 1 to Cycle 2 Day 7 (Cycle length= 14 days)

Population: The DLT-evaluable population included all participants in Part A who received at least two doses of study medication and either experienced a DLT within the DLT period or cleared the DLT period without a DLT.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=19 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Part A: Number of Participants With a Dose-Limiting Toxicity (DLT)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months)

Population: Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.

AE=any untoward medical occurrence in a participant administered a pharmaceutical product \& which does not necessarily have a causal relationship with treatment \& can therefore be any unfavorable \& unintended sign (including abnormal laboratory values/abnormal clinical test results), symptoms/disease temporally associated with the use of pharmaceutical product, whether or not considered related to pharmaceutical product. Severity of AEs was graded as: Grade 1=Mild, asymptomatic/mild symptoms, clinical/diagnostic observations only, or intervention not indicated; Grade 2=Moderate, minimal, local/non-invasive intervention indicated, or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe/medically significant but not immediately life-threatening, hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4= Life-threatening consequences, urgent intervention indicated; Grade 5=Death related to AE.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=19 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Part A: Number of Participants With at Least One AE by Highest Severity, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) AEs (Any grade)	3 Participants	5 Participants	4 Participants	4 Participants	3 Participants	18 Participants	—	—	—	—	—	—
Part A: Number of Participants With at Least One AE by Highest Severity, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) Grade 1 AE	0 Participants	3 Participants	1 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—
Part A: Number of Participants With at Least One AE by Highest Severity, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) Grade 2 AE	2 Participants	1 Participants	2 Participants	2 Participants	1 Participants	9 Participants	—	—	—	—	—	—
Part A: Number of Participants With at Least One AE by Highest Severity, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) Grade 3 AE	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants	7 Participants	—	—	—	—	—	—
Part A: Number of Participants With at Least One AE by Highest Severity, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) Grade 4 AE	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 then every 8 weeks for the first year; every 12 weeks thereafter until disease progression or treatment discontinuation (whichever occurs last), initiation of a new line of therapy or death (Up to 43.3 months) (Cycle length= 14 days)

Population: Efficacy population included all participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.

ORR was defined as the percentage of participants with an objective tumor response of complete response (CR) or partial response (PR) as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=38 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=25 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=15 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=15 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Part B: Objective Response Rate (ORR) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	7.9 percentage of participants 90% Confidence Interval 2.19 • Interval 2.19 to 19.16	0 percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 11.29	0 percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 18.1	20.0 percentage of participants 90% Confidence Interval 5.68 • Interval 5.68 to 43.98	—	—	—	—	—	—	—	—

PRIMARY outcome

Population: Efficacy population included all participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.

DCR was defined as the percentage of participants with an objective tumor response of CR, PR or stable disease (SD) as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression (PD). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=38 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=25 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=15 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=15 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Part B: Disease Control Rate (DCR) as Determined by Investigator Using RECIST v1.1	36.8 percentage of participants 90% Confidence Interval 23.83 • Interval 23.83 to 51.47	36.0 percentage of participants 90% Confidence Interval 20.24 • Interval 20.24 to 54.39	0 percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 18.1	60.0 percentage of participants 90% Confidence Interval 35.96 • Interval 35.96 to 80.91	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From first occurrence of documented OR up to disease progression or death (Up to 43.3 months) (Cycle length = 14 days)

Population: Efficacy population included all participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment. Overall number analyzed is the number of participants with OR, i.e., responders.

DOR was calculated for participants who had a best confirmed overall response (OR) of CR/PR. DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death (within 30 days from last treatment) from any cause, whichever occurs first as determined by investigator assessment using RECIST v1.1. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Data for participants without PD or death as of the data cut-off date were censored at the time of the last tumor assessment.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=3 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Part B: Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1	17.7 months Interval 3.9 to The upper limit of the 90% confidence interval (CI) was not estimable due to insufficient number of participants with events.	—	—	10.6 months Interval 3.9 to The upper limit of the 90% CI was not estimable due to insufficient number of participants with events.	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From treatment initiation (Cycle 1 Day 1) until disease progression or death (Up to 43.3 months) (Cycle length= 14 days)

Population: Efficacy population included all participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.

PFS was defined as the time from study treatment initiation (Cycle 1 Day 1) to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Data for participants without PD or death as of the data cut-off date were censored at the time of the last tumor assessment.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=38 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=25 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=15 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=15 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Part B: Progression Free Survival (PFS) as Determined by Investigator Using RECIST v1.1	1.8 months 90% Confidence Interval 1.7 • Interval 1.7 to 2.0	1.7 months 90% Confidence Interval 1.6 • Interval 1.6 to 1.9	1.7 months 90% Confidence Interval 1.6 • Interval 1.6 to 1.8	3.6 months 90% Confidence Interval 1.5 • Interval 1.5 to 5.7	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 1 of Cycles 1 to 5; Day 1 of Cycle 7, and every 6 cycles thereafter (1 cycle is 14 days); study completion/discontinuation; safety follow-up visits (up to approximately 40.8 months - Part A and 45.4 months - Part B)

Population: Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. The number of participants analyzed for each group indicates the number of participants with an ADA assay result from at least one post-baseline sample.

Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 4-fold (treatment-enhanced ADA response).

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=3 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=3 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=17 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort n=37 Participants Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 n=25 Participants Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=14 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=16 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs)	3 Participants	2 Participants	0 Participants	0 Participants	1 Participants	3 Participants	5 Participants	7 Participants	1 Participants	6 Participants	—	—

SECONDARY outcome

Timeframe: Days 1, 2, and 8 of Cycles 1 and 5; Day 1 of Cycles 2, 3, and 9 (1 cycle is 14 days); study completion visit (28 days after last dose; up to 43.3 months); safety follow-up (SFU) (90 days after last dose; up to 45.4 months)

Population: The safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed = participants with data available for analysis. Number analyzed = participants with data available for analysis at the specified timepoint.

Biomarker analyses were performed using peripheral blood samples that were collected from participants in Part B of the study. The blood samples were assessed by flow cytometry for absolute counts of CD3⁺CD8⁺ T cells and proliferating CD3⁺CD8⁺Ki67⁺ T cells.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=37 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=26 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=15 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=2 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+: Cycle 1 Day 1	350.63 cells per microliter (cells/µL) Standard Deviation 186.81	293.25 cells per microliter (cells/µL) Standard Deviation 137.62	252.60 cells per microliter (cells/µL) Standard Deviation 224.48	256.00 cells per microliter (cells/µL) Standard Deviation 138.59	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+: Cycle 1 Day 2	371.61 cells per microliter (cells/µL) Standard Deviation 219.58	317.28 cells per microliter (cells/µL) Standard Deviation 175.47	296.20 cells per microliter (cells/µL) Standard Deviation 519.44	306.50 cells per microliter (cells/µL) Standard Deviation 111.02	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+: Cycle 1 Day 8	364.09 cells per microliter (cells/µL) Standard Deviation 264.35	342.59 cells per microliter (cells/µL) Standard Deviation 223.74	292.47 cells per microliter (cells/µL) Standard Deviation 349.48	329.00 cells per microliter (cells/µL) Standard Deviation NA Since only 1 participant was analyzed, the standard deviation (SD) could not be calculated.	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+: Cycle 2 Day 1	378.54 cells per microliter (cells/µL) Standard Deviation 250.58	298.91 cells per microliter (cells/µL) Standard Deviation 153.88	245.93 cells per microliter (cells/µL) Standard Deviation 226.21	257.00 cells per microliter (cells/µL) Standard Deviation 66.47	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+: Cycle 3 Day 1	422.00 cells per microliter (cells/µL) Standard Deviation 380.62	310.47 cells per microliter (cells/µL) Standard Deviation 171.87	193.18 cells per microliter (cells/µL) Standard Deviation 81.24	199.00 cells per microliter (cells/µL) Standard Deviation NA Since only 1 participant was analyzed, the SD could not be calculated.	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+: Cycle 5 Day 1	403.88 cells per microliter (cells/µL) Standard Deviation 270.34	269.00 cells per microliter (cells/µL) Standard Deviation 106.32	234.00 cells per microliter (cells/µL) Standard Deviation 72.48	—	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+: Cycle 5 Day 2	445.53 cells per microliter (cells/µL) Standard Deviation 228.03	285.71 cells per microliter (cells/µL) Standard Deviation 120.35	260.50 cells per microliter (cells/µL) Standard Deviation 59.52	—	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+: Cycle 5 Day 8	516.80 cells per microliter (cells/µL) Standard Deviation 332.31	267.57 cells per microliter (cells/µL) Standard Deviation 116.42	179.00 cells per microliter (cells/µL) Standard Deviation 68.02	—	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+: Cycle 9 Day 1	503.91 cells per microliter (cells/µL) Standard Deviation 425.19	—	237.00 cells per microliter (cells/µL) Standard Deviation NA Since only 1 participant was analyzed, the SD could not be calculated.	—	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+: SFU	429.38 cells per microliter (cells/µL) Standard Deviation 302.79	453.00 cells per microliter (cells/µL) Standard Deviation 212.13	201.00 cells per microliter (cells/µL) Standard Deviation 209.30	—	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+: Study Completion	296.70 cells per microliter (cells/µL) Standard Deviation 177.13	289.83 cells per microliter (cells/µL) Standard Deviation 168.98	193.80 cells per microliter (cells/µL) Standard Deviation 136.60	—	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+Ki67+: Cycle 1 Day 1	12.45 cells per microliter (cells/µL) Standard Deviation 8.64	11.83 cells per microliter (cells/µL) Standard Deviation 8.67	7.36 cells per microliter (cells/µL) Standard Deviation 5.51	5.50 cells per microliter (cells/µL) Standard Deviation 2.12	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+Ki67+: Cycle 1 Day 2	13.94 cells per microliter (cells/µL) Standard Deviation 16.29	13.00 cells per microliter (cells/µL) Standard Deviation 12.76	7.71 cells per microliter (cells/µL) Standard Deviation 7.45	8.00 cells per microliter (cells/µL) Standard Deviation 2.83	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+Ki67+: Cycle 1 Day 8	14.34 cells per microliter (cells/µL) Standard Deviation 11.67	13.64 cells per microliter (cells/µL) Standard Deviation 12.62	11.00 cells per microliter (cells/µL) Standard Deviation 4.88	13.00 cells per microliter (cells/µL) Standard Deviation NA Since only 1 participant was analyzed, the SD could not be calculated.	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+Ki67+: Cycle 2 Day 1	18.12 cells per microliter (cells/µL) Standard Deviation 22.33	17.52 cells per microliter (cells/µL) Standard Deviation 23.14	14.87 cells per microliter (cells/µL) Standard Deviation 6.62	8.50 cells per microliter (cells/µL) Standard Deviation 0.71	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+Ki67+: Cycle 3 Day 1	16.10 cells per microliter (cells/µL) Standard Deviation 23.21	13.41 cells per microliter (cells/µL) Standard Deviation 9.21	13.45 cells per microliter (cells/µL) Standard Deviation 8.71	8.00 cells per microliter (cells/µL) Standard Deviation NA Since only 1 participant was analyzed, the SD could not be calculated.	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+Ki67+: Cycle 5 Day 1	16.27 cells per microliter (cells/µL) Standard Deviation 12.27	6.88 cells per microliter (cells/µL) Standard Deviation 2.42	9.00 cells per microliter (cells/µL) Standard Deviation 1.73	—	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+Ki67+: Cycle 5 Day 2	19.63 cells per microliter (cells/µL) Standard Deviation 26.26	7.83 cells per microliter (cells/µL) Standard Deviation 4.17	6.75 cells per microliter (cells/µL) Standard Deviation 2.22	—	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+Ki67+: Cycle 5 Day 8	15.33 cells per microliter (cells/µL) Standard Deviation 9.98	7.00 cells per microliter (cells/µL) Standard Deviation 2.08	6.67 cells per microliter (cells/µL) Standard Deviation 3.79	—	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+Ki67+: Cycle 9 Day 1	14.27 cells per microliter (cells/µL) Standard Deviation 12.58	—	6.00 cells per microliter (cells/µL) Standard Deviation NA Since only 1 participant was analyzed, the SD could not be calculated.	—	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+Ki67+: SFU	15.63 cells per microliter (cells/µL) Standard Deviation 12.93	22.50 cells per microliter (cells/µL) Standard Deviation 14.85	7.50 cells per microliter (cells/µL) Standard Deviation 7.78	—	—	—	—	—	—	—	—	—
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood CD3+CD8+Ki67+: Study Completion	10.58 cells per microliter (cells/µL) Standard Deviation 7.80	9.58 cells per microliter (cells/µL) Standard Deviation 10.49	14.80 cells per microliter (cells/µL) Standard Deviation 9.31	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At screening and Cycle 3 Day 1

Population: Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed = participants with data available for analysis. Number analyzed=number of participants with data available for analysis at the specified timepoint.

Fresh tumor biopsies were collected from participants in Part B of the study to assess changes in T-cell infiltration and activation within the tumor microenvironment. Tumor tissue was evaluated for CD8⁺ T-cell densities. The tumor tissue samples were collected at screening (archival metastasis and archival primary samples) and during the study (fresh samples).

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=25 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=19 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=5 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=7 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies Fresh Sample 2	912.58 cells per millimetre square (cells/mm^2) Standard Deviation 1089.90	790.76 cells per millimetre square (cells/mm^2) Standard Deviation 462.38	288.21 cells per millimetre square (cells/mm^2) Standard Deviation NA Since only 1 participant was analyzed, the SD could not be calculated.	322.23 cells per millimetre square (cells/mm^2) Standard Deviation 256.74	—	—	—	—	—	—	—	—
Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies Archival Metastasis Samples	215.16 cells per millimetre square (cells/mm^2) Standard Deviation 319.52	29.51 cells per millimetre square (cells/mm^2) Standard Deviation NA Since only 1 participant was analyzed, the SD could not be calculated.	—	—	—	—	—	—	—	—	—	—
Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies Archival Primary Samples	374.92 cells per millimetre square (cells/mm^2) Standard Deviation 530.17	764.26 cells per millimetre square (cells/mm^2) Standard Deviation 470.25	—	275.02 cells per millimetre square (cells/mm^2) Standard Deviation 347.75	—	—	—	—	—	—	—	—
Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies Fresh Sample 1	1090.51 cells per millimetre square (cells/mm^2) Standard Deviation 1001.71	765.44 cells per millimetre square (cells/mm^2) Standard Deviation 986.47	221.87 cells per millimetre square (cells/mm^2) Standard Deviation 363.76	510.21 cells per millimetre square (cells/mm^2) Standard Deviation 601.10	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)

Population: Pharmacokinetic (PK) population included all participants who have received at least one dose of study treatment and who have data from at least one post-dose sample. Overall number analyzed = participants with data available for analysis. Number analyzed = participants with data available for analysis at the specified timepoint.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=4 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort n=4 Participants Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 n=11 Participants Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=38 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=25 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=15 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=16 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig Cycle 1	0.09 days Interval 0.09 to 0.17	0.09 days Interval 0.09 to 1.0	0.125 days Interval 0.09 to 0.17	0.17 days Interval 0.09 to 0.26	0.17 days Interval 0.17 to 0.25	0.09 days Interval 0.09 to 0.19	0.175 days Interval 0.17 to 0.25	0.18 days Interval 0.09 to 0.28	0.17 days Interval 0.04 to 1.24	0.1 days Interval 0.04 to 0.18	0.17 days Interval 0.09 to 0.91	0.17 days Interval 0.08 to 0.25
Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig Cycle 5	0.16 days Interval 0.16 to 0.16	0.17 days Interval 0.09 to 0.25	2.5 days Interval 1.0 to 4.01	3.57 days Interval 1.12 to 6.02	0.17 days Interval 0.17 to 0.17	0.17 days Interval 0.17 to 0.17	0.21 days Interval 0.09 to 0.22	0.215 days Interval 0.09 to 0.23	0.1 days Interval 0.0 to 0.98	0.1 days Interval 0.02 to 3.13	0.11 days Interval 0.03 to 0.11	0.1 days Interval 0.01 to 0.88

SECONDARY outcome

Population: PK population included all participants who have received at least one dose of study treatment and who have data from at least one post-dose sample. Overall number analyzed = participants with data available for analysis. Number analyzed = participants with data available for analysis at the specified timepoint.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=4 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort n=4 Participants Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 n=11 Participants Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=38 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=25 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=15 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=16 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig Cycle 5	20.2 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation could not be calculated.	128 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 8.3	116 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 116.9	546 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 14.8	781 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 30.8	1600 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation could not be calculated.	1500 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 0.0	1520 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 17.5	1420 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 32.6	1270 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 33.1	1240 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 23.0	1280 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 25.7
Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig Cycle 1	21.5 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 40.0	61.7 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 25.2	148 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 18.5	408 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 5.7	530 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 20.8	518 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 8.8	575 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 29.4	740 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 14.4	791 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 43.3	704 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 26.2	726 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 16.1	754 micrograms/milliliters (µg/mL) Geometric Coefficient of Variation 24.5

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=4 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort n=4 Participants Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 n=11 Participants Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=38 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=25 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=15 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=16 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig Cycle 5	0.777 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation could not be calculated.	0.608 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 8.4	0.188 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 117.0	0.455 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 14.8	0.434 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 30.8	0.762 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation could not be calculated.	0.714 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 0.0	0.725 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 17.5	0.675 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 32.6	0.607 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 33.0	0.592 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 22.9	0.609 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 25.8
Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig Cycle 1	0.307 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 40.0	0.294 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 25.3	0.24 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 18.5	0.34 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 5.7	0.295 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 20.9	0.246 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 8.8	0.274 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 29.4	0.352 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 14.3	0.377 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 43.2	0.335 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 26.2	0.346 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 16.1	0.359 microgram/milliliter/milligram(µg/mL/mg) Geometric Coefficient of Variation 24.4

SECONDARY outcome

For participants who experienced an adverse event (AE) following infusion with lomvastomig, a delay of the next administration for up to two cycles was acceptable to allow for resolution of toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 2 or lower for hematological toxicities or Grade 1 or lower for non-hematological toxicities (with the exception of a toxicity considered as not related to study drug). In the case of a delayed administration, the predose PK sample for Day 1 of Cycles 2 and/or 6 could have been collected up to 28 days after the end of the previous treatment cycle.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=4 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort n=4 Participants Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 n=11 Participants Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=38 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=25 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=15 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=16 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig Cycle 1	14 days Interval 13.9 to 14.0	14 days Interval 13.9 to 14.0	14 days Interval 13.9 to 14.1	14 days Interval 11.8 to 14.2	14 days Interval 11.0 to 14.1	14 days Interval 4.06 to 14.1	14.1 days Interval 13.9 to 14.2	14 days Interval 6.97 to 14.3	14 days Interval 6.07 to 16.0	14 days Interval 10.1 to 42.0	14 days Interval 13.9 to 22.1	14 days Interval 10.9 to 28.0
Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig Cycle 5	16.9 days Interval 16.9 to 16.9	14 days Interval 14.0 to 14.0	14.1 days Interval 14.0 to 14.1	14.1 days Interval 14.0 to 14.1	15 days Interval 14.1 to 16.0	14 days Interval 14.0 to 14.0	14 days Interval 14.0 to 28.0	14.5 days Interval 13.9 to 16.0	14 days Interval 13.8 to 20.2	14 days Interval 13.9 to 22.0	14.5 days Interval 12.9 to 17.0	14.2 days Interval 13.9 to 21.0

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=4 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort n=4 Participants Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 n=11 Participants Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=38 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=25 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=15 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=16 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig Cycle 1	5.52 µg/mL Geometric Coefficient of Variation 23.6	21.4 µg/mL Geometric Coefficient of Variation 9.2	40.4 µg/mL Geometric Coefficient of Variation 43.2	116 µg/mL Geometric Coefficient of Variation 17.0	147 µg/mL Geometric Coefficient of Variation 39.1	157 µg/mL Geometric Coefficient of Variation 43.2	157 µg/mL Geometric Coefficient of Variation 29.4	245 µg/mL Geometric Coefficient of Variation 29.3	217 µg/mL Geometric Coefficient of Variation 38.2	184 µg/mL Geometric Coefficient of Variation 54.1	194 µg/mL Geometric Coefficient of Variation 24.8	216 µg/mL Geometric Coefficient of Variation 46.1
Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig Cycle 5	2.16 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation could not be calculated.	62.2 µg/mL Geometric Coefficient of Variation 14.5	59.7 µg/mL Geometric Coefficient of Variation 37.4	267 µg/mL Geometric Coefficient of Variation 8.8	415 µg/mL Geometric Coefficient of Variation 24.6	661 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation could not be calculated.	549 µg/mL Geometric Coefficient of Variation 22.0	678 µg/mL Geometric Coefficient of Variation 32.7	520 µg/mL Geometric Coefficient of Variation 49.6	495 µg/mL Geometric Coefficient of Variation 39.2	470 µg/mL Geometric Coefficient of Variation 59.0	533 µg/mL Geometric Coefficient of Variation 44.3

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=4 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort n=4 Participants Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 n=11 Participants Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=38 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=25 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=15 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=16 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig Cycle 5	114 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation could not be calculated.	1200 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 8.0	1120 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 73.6	5470 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 17.3	6620 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 13.6	12200 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation could not be calculated.	13800 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 28.0	14200 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 28.4	11500 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 43.5	11700 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 38.1	9910 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 39.5	11700 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 28.7
Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig Cycle 1	140 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 37.8	426 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 16.0	927 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 28.8	2540 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 22.1	3040 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 31.6	2700 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 52.0	3700 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 26.8	4880 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 30.0	4700 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 27.9	4600 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 27.3	4720 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 25.7	5200 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 24.4

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=4 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort n=4 Participants Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 n=11 Participants Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=38 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=25 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=15 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=16 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig Cycle 5	105 day*µg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation could not be calculated.	1190 day*µg/mL Geometric Coefficient of Variation 7.7	1110 day*µg/mL Geometric Coefficient of Variation 74.2	5440 day*µg/mL Geometric Coefficient of Variation 17.6	6260 day*µg/mL Geometric Coefficient of Variation 21.3	12300 day*µg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation could not be calculated.	11700 day*µg/mL Geometric Coefficient of Variation 1.3	13700 day*µg/mL Geometric Coefficient of Variation 26.4	11200 day*µg/mL Geometric Coefficient of Variation 41.1	11200 day*µg/mL Geometric Coefficient of Variation 36.1	9650 day*µg/mL Geometric Coefficient of Variation 41.5	11100 day*µg/mL Geometric Coefficient of Variation 33.6
Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig Cycle 1	140 day*µg/mL Geometric Coefficient of Variation 37.8	427 day*µg/mL Geometric Coefficient of Variation 15.9	932 day*µg/mL Geometric Coefficient of Variation 29.0	2600 day*µg/mL Geometric Coefficient of Variation 17.4	3120 day*µg/mL Geometric Coefficient of Variation 26.6	3180 day*µg/mL Geometric Coefficient of Variation 17.3	3680 day*µg/mL Geometric Coefficient of Variation 26.9	5060 day*µg/mL Geometric Coefficient of Variation 20.0	4730 day*µg/mL Geometric Coefficient of Variation 24.0	4550 day*µg/mL Geometric Coefficient of Variation 29.6	4590 day*µg/mL Geometric Coefficient of Variation 20.2	5150 day*µg/mL Geometric Coefficient of Variation 25.4

SECONDARY outcome

Timeframe: Predose and EOI: Day 1 of Cycles 1 and 5; Predose: Day 1 of Cycles 2, 3, and 9; Postdose: Day 8 of Cycles 1 and 5 (1 cycle is 14 days); study completion (28 days after last dose; up to 39.7 months); SFU (60 days after last dose; up to 40.8 months)

Population: Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed = participants with data available for analysis. Number analyzed = participants with data available for analysis at the specified timepoint.

Blood samples were collected from participants in Part A of the study and different types of immune cells were assessed by flow cytometry for the percentage of receptor occupancy (RO) by lomvastomig. RO (or drug coverage) is used to quantify the binding of the therapeutic to its target on the cell surface. The RO of lomvastomig was determined on cells that were positive (+) for CD3+, CD4+, CD56+/16+, and CD8+.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=18 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD8+: EOI on Cycle 5 Day 1	75.00 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	100.17 percent occupancy Standard Deviation 8.18	117.60 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	94.30 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	88.50 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	93.90 percent occupancy Standard Deviation 15.31	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD4+: EOI on Cycle 1 Day 1	68.60 percent occupancy Standard Deviation 47.94	92.28 percent occupancy Standard Deviation 5.74	107.58 percent occupancy Standard Deviation 3.57	99.80 percent occupancy Standard Deviation 11.72	102.67 percent occupancy Standard Deviation 12.71	96.63 percent occupancy Standard Deviation 25.26	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD4+: Postdose on Cycle 1 Day 8	97.65 percent occupancy Standard Deviation 16.48	101.40 percent occupancy Standard Deviation 16.85	106.53 percent occupancy Standard Deviation 21.55	92.18 percent occupancy Standard Deviation 13.53	88.40 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	103.77 percent occupancy Standard Deviation 28.34	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD4+: Study Completion	87.05 percent occupancy Standard Deviation 8.70	95.07 percent occupancy Standard Deviation 4.60	98.40 percent occupancy Standard Deviation 24.04	97.65 percent occupancy Standard Deviation 7.99	100.95 percent occupancy Standard Deviation 1.34	97.98 percent occupancy Standard Deviation 10.69	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD56+/16+:EOI on Cycle 1 Day 1	86.80 percent occupancy Standard Deviation 29.86	100.32 percent occupancy Standard Deviation 22.37	107.25 percent occupancy Standard Deviation 10.70	90.58 percent occupancy Standard Deviation 73.61	117.73 percent occupancy Standard Deviation 38.13	103.07 percent occupancy Standard Deviation 27.26	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD56+/16+:Predose on Cycle 3 Day 1	20.00 percent occupancy Standard Deviation 28.28	60.76 percent occupancy Standard Deviation 36.97	42.40 percent occupancy Standard Deviation 59.96	55.35 percent occupancy Standard Deviation 31.18	71.83 percent occupancy Standard Deviation 18.61	115.75 percent occupancy Standard Deviation 57.23	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD56+/16+:EOI on Cycle 5 Day 1	73.90 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	73.33 percent occupancy Standard Deviation 64.07	32.15 percent occupancy Standard Deviation 25.24	75.00 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	91.00 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	100.64 percent occupancy Standard Deviation 11.65	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD56+/16+:Postdose on Cycle 5 Day 8	3000.00 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	108.97 percent occupancy Standard Deviation 15.53	0.00 percent occupancy Standard Deviation 0.00	83.35 percent occupancy Standard Deviation 23.55	100.50 percent occupancy Standard Deviation 3.96	107.59 percent occupancy Standard Deviation 31.13	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD56+/16+:Predose on Cycle 9 Day 1	194.10 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	25.00 percent occupancy Standard Deviation 35.36	—	105.60 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	89.00 percent occupancy Standard Deviation 4.67	98.86 percent occupancy Standard Deviation 18.06	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD8+: Predose on Cycle 1 Day 1	36.37 percent occupancy Standard Deviation 40.21	36.23 percent occupancy Standard Deviation 23.99	53.37 percent occupancy Standard Deviation 18.41	0.00 percent occupancy Standard Deviation 0.00	—	17.60 percent occupancy Standard Deviation 25.08	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD8+: EOI on Cycle 1 Day 1	74.37 percent occupancy Standard Deviation 44.30	95.60 percent occupancy Standard Deviation 4.75	106.88 percent occupancy Standard Deviation 11.27	97.18 percent occupancy Standard Deviation 12.62	94.80 percent occupancy Standard Deviation 19.83	99.85 percent occupancy Standard Deviation 25.09	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD8+: Postdose on Cycle 1 Day 8	109.03 percent occupancy Standard Deviation 9.42	97.48 percent occupancy Standard Deviation 10.55	107.10 percent occupancy Standard Deviation 19.15	91.88 percent occupancy Standard Deviation 19.21	100.00 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	105.34 percent occupancy Standard Deviation 23.71	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD8+: Predose on Cycle 3 Day 1	109.13 percent occupancy Standard Deviation 22.69	88.66 percent occupancy Standard Deviation 11.84	58.30 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	94.50 percent occupancy Standard Deviation 8.91	100.00 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	95.82 percent occupancy Standard Deviation 35.78	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD8+: Predose on Cycle 5 Day 1	42.90 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	100.67 percent occupancy Standard Deviation 1.15	110.50 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	115.20 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	89.15 percent occupancy Standard Deviation 12.52	111.22 percent occupancy Standard Deviation 23.82	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD8+: Postdose on Cycle 5 Day 8	305.30 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	89.33 percent occupancy Standard Deviation 10.45	—	92.55 percent occupancy Standard Deviation 4.17	106.05 percent occupancy Standard Deviation 10.25	103.67 percent occupancy Standard Deviation 9.40	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD8+: Predose on Cycle 9 Day 1	118.50 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	101.25 percent occupancy Standard Deviation 1.77	—	94.40 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	107.90 percent occupancy Standard Deviation 9.33	109.20 percent occupancy Standard Deviation 23.66	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD8+: SFU	108.75 percent occupancy Standard Deviation 7.85	134.55 percent occupancy Standard Deviation 0.78	—	93.90 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	88.75 percent occupancy Standard Deviation 2.19	100.75 percent occupancy Standard Deviation 1.06	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD8+: Study Completion	86.45 percent occupancy Standard Deviation 19.16	91.00 percent occupancy Standard Deviation 23.91	103.00 percent occupancy Standard Deviation 26.02	99.90 percent occupancy Standard Deviation 11.88	101.25 percent occupancy Standard Deviation 1.20	93.83 percent occupancy Standard Deviation 10.53	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD3+: Predose on Cycle 1 Day 1	41.80 percent occupancy Standard Deviation 37.87	36.23 percent occupancy Standard Deviation 26.52	34.77 percent occupancy Standard Deviation 7.79	0.28 percent occupancy Standard Deviation 0.55	—	14.37 percent occupancy Standard Deviation 21.43	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD3+: EOI on Cycle 1 Day 1	70.43 percent occupancy Standard Deviation 46.32	93.22 percent occupancy Standard Deviation 3.03	106.48 percent occupancy Standard Deviation 5.25	98.73 percent occupancy Standard Deviation 12.28	97.47 percent occupancy Standard Deviation 10.11	95.69 percent occupancy Standard Deviation 24.36	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD3+: Postdose on Cycle 1 Day 8	108.47 percent occupancy Standard Deviation 4.50	99.03 percent occupancy Standard Deviation 14.31	105.33 percent occupancy Standard Deviation 19.23	90.10 percent occupancy Standard Deviation 15.62	91.30 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	102.53 percent occupancy Standard Deviation 20.01	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD3+:Predose on Cycle 5 Day 1	62.10 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	100.20 percent occupancy Standard Deviation 5.10	124.10 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated..	140.50 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	94.90 percent occupancy Standard Deviation 8.77	92.72 percent occupancy Standard Deviation 48.52	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD3+: Predose on Cycle 2 Day 1	105.13 percent occupancy Standard Deviation 9.63	95.53 percent occupancy Standard Deviation 4.74	92.80 percent occupancy Standard Deviation 15.65	93.17 percent occupancy Standard Deviation 4.25	100.00 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	100.30 percent occupancy Standard Deviation 12.10	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD3+: Predose on Cycle 3 Day 1	100.33 percent occupancy Standard Deviation 8.21	90.62 percent occupancy Standard Deviation 9.67	52.20 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	92.90 percent occupancy Standard Deviation 11.46	96.90 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	105.48 percent occupancy Standard Deviation 25.17	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD3+: EOI on Cycle 5 Day 1	82.60 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	95.23 percent occupancy Standard Deviation 16.77	128.60 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	106.60 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	82.20 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	95.77 percent occupancy Standard Deviation 12.49	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD3+: Postdose on Cycle 5 Day 8	206.70 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	93.17 percent occupancy Standard Deviation 12.72	—	96.95 percent occupancy Standard Deviation 4.31	106.90 percent occupancy Standard Deviation 12.30	108.28 percent occupancy Standard Deviation 15.34	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD3+: Predose on Cycle 9 Day 1	117.90 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	92.45 percent occupancy Standard Deviation 6.58	—	101.20 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	101.40 percent occupancy Standard Deviation 0.00	113.55 percent occupancy Standard Deviation 20.00	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD3+: SFU	98.70 percent occupancy Standard Deviation 1.84	128.10 percent occupancy Standard Deviation 18.38	—	95.00 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	90.25 percent occupancy Standard Deviation 2.05	98.35 percent occupancy Standard Deviation 2.33	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD3+: Study Completion	86.35 percent occupancy Standard Deviation 7.71	88.93 percent occupancy Standard Deviation 6.90	94.75 percent occupancy Standard Deviation 21.57	98.95 percent occupancy Standard Deviation 9.69	100.50 percent occupancy Standard Deviation 0.71	96.73 percent occupancy Standard Deviation 9.11	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD4+: Predose on Cycle 1 Day 1	39.93 percent occupancy Standard Deviation 29.46	37.77 percent occupancy Standard Deviation 32.40	30.07 percent occupancy Standard Deviation 1.95	5.70 percent occupancy Standard Deviation 7.96	—	16.37 percent occupancy Standard Deviation 20.93	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD4+: Predose on Cycle 2 Day 1	98.77 percent occupancy Standard Deviation 16.42	94.28 percent occupancy Standard Deviation 5.71	97.23 percent occupancy Standard Deviation 10.71	91.33 percent occupancy Standard Deviation 9.38	102.00 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	100.77 percent occupancy Standard Deviation 12.11	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD4+: Predose on Cycle 3 Day 1	94.40 percent occupancy Standard Deviation 3.82	93.38 percent occupancy Standard Deviation 7.51	60.60 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	90.00 percent occupancy Standard Deviation 9.48	100.00 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	98.44 percent occupancy Standard Deviation 33.59	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD4+: Predose on Cycle 5 Day 1	68.60 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	96.27 percent occupancy Standard Deviation 7.48	144.70 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	165.50 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	95.65 percent occupancy Standard Deviation 6.15	112.00 percent occupancy Standard Deviation 17.78	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD4+: EOI on Cycle 5 Day 1	103.10 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	91.80 percent occupancy Standard Deviation 18.83	130.30 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	114.60 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	79.10 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	94.86 percent occupancy Standard Deviation 20.02	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD4+: Postdose on Cycle 5 Day 1	146.70 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	95.60 percent occupancy Standard Deviation 11.36	—	97.60 percent occupancy Standard Deviation 8.77	108.10 percent occupancy Standard Deviation 14.42	102.90 percent occupancy Standard Deviation 16.18	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD4+: Predose on Cycle 9 Day 1	108.20 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	93.55 percent occupancy Standard Deviation 15.06	—	105.10 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	99.15 percent occupancy Standard Deviation 5.16	109.45 percent occupancy Standard Deviation 12.18	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD4+: SFU	88.00 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	129.45 percent occupancy Standard Deviation 31.47	—	94.60 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	92.15 percent occupancy Standard Deviation 2.19	98.30 percent occupancy Standard Deviation 5.23	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD56+/16+:Predose on Cycle 1 Day 1	57.53 percent occupancy Standard Deviation 49.85	88.43 percent occupancy Standard Deviation 37.59	88.87 percent occupancy Standard Deviation 11.20	37.73 percent occupancy Standard Deviation 65.36	73.55 percent occupancy Standard Deviation 27.93	88.31 percent occupancy Standard Deviation 43.57	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD56+/16+:Postdose on Cycle 1 Day 8	98.43 percent occupancy Standard Deviation 56.80	123.60 percent occupancy Standard Deviation 49.67	90.18 percent occupancy Standard Deviation 9.67	67.53 percent occupancy Standard Deviation 17.54	101.90 percent occupancy Standard Deviation 39.74	106.75 percent occupancy Standard Deviation 64.75	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD56+/16+:Predose on Cycle 2 Day 1	100.00 percent occupancy Standard Deviation 0.00	89.10 percent occupancy Standard Deviation 3.99	47.83 percent occupancy Standard Deviation 36.63	34.83 percent occupancy Standard Deviation 30.25	112.15 percent occupancy Standard Deviation 35.85	101.78 percent occupancy Standard Deviation 20.05	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD56+/16+:Predose on Cycle 5 Day 1	100.00 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	82.10 percent occupancy Standard Deviation 21.67	50.80 percent occupancy Standard Deviation 5.23	25.00 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	90.35 percent occupancy Standard Deviation 2.05	107.54 percent occupancy Standard Deviation 26.49	—	—	—	—	—	—
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay CD8+: Predose on Cycle 2 Day 1	113.70 percent occupancy Standard Deviation 2.36	95.95 percent occupancy Standard Deviation 3.72	95.13 percent occupancy Standard Deviation 27.80	96.63 percent occupancy Standard Deviation 5.83	95.00 percent occupancy Standard Deviation NA Since only 1 participant was analyzed, SD could not be calculated.	98.85 percent occupancy Standard Deviation 16.69	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months)

Population: Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=38 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=26 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=15 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=16 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 Grade 3 AE	11 Participants	9 Participants	8 Participants	10 Participants	—	—	—	—	—	—	—	—
Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 Grade 4 AE	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 Grade 5 AE	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 Grade 2 AE	15 Participants	10 Participants	5 Participants	4 Participants	—	—	—	—	—	—	—	—
Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 AEs (Any Grade)	34 Participants	25 Participants	15 Participants	16 Participants	—	—	—	—	—	—	—	—
Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0 Grade 1 AE	7 Participants	5 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: Efficacy population included all participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.

ORR was defined as the percentage of participants with an objective tumor response of CR or PR as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=19 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Part A: ORR as Determined by Investigator Using RECIST v1.1	0 percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 63.16	0 percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 45.07	0 percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 52.71	0 percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 52.71	0 percentage of participants 90% Confidence Interval 0.00 • Interval 0.0 to 52.71	21.1 percentage of participants 90% Confidence Interval 7.53 • Interval 7.53 to 41.91	—	—	—	—	—	—

SECONDARY outcome

Population: Efficacy population included all participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.

DCR was defined as the percentage of participants with an objective tumor response of CR, PR or SD as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=19 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Part A: DCR as Determined by Investigator Using RECIST v1.1	33.3 percentage of participants Interval 1.7 to 86.46	40.0 percentage of participants Interval 7.64 to 81.07	0 percentage of participants Interval 0.0 to 52.71	50.0 percentage of participants Interval 9.76 to 90.24	25.0 percentage of participants Interval 1.27 to 75.14	42.1 percentage of participants Interval 22.97 to 63.19	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first occurrence of documented OR up to disease progression or death (Up to 39.7 months) (Cycle length= 14 days)

Population: Efficacy population included participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment. Overall number analyzed included participants with OR i.e., responders.

DOR was calculated for participants who had a best confirmed OR of CR/PR. DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurs first as determined by investigator assessment using RECIST v1.1. CR=the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR=at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Data for participants without PD or death from any cause as of the data cut-off date were censored at the time of the last tumor assessment.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=4 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Part A: DOR as Determined by Investigator Using RECIST v1.1	—	—	—	—	—	13.8 months Interval 5.6 to The upper limit of the 90% CI was not estimable due to insufficient number of participants with events.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From initiation of study treatment (Cycle 1 Day 1) until disease progression or death (Up to 39.7 months) (Cycle length= 14 days)

Population: Efficacy population included all participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.

Outcome measures

Outcome measures
Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=19 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Part A: PFS as Determined by Investigator Using RECIST v1.1	1.8 months Interval 1.7 to The upper limit of the 90% CI was not estimable due to insufficient number of participants with events.	2.0 months Interval 1.9 to 5.4	1.6 months Interval 1.0 to The upper limit of the 90% CI was not estimable due to insufficient number of participants with events.	NA months Interval 0.7 to The median and upper limit of the 90% CI was not estimable due to insufficient number of participants with events.	1.8 months Interval 0.6 to The upper limit of the 90% CI was not estimable due to insufficient number of participants with events.	1.9 months Interval 1.7 to 3.5	—	—	—	—	—	—

Adverse Events

Part A: Lomvastomig 70mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Part A: Lomvastomig 210 mg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 3 deaths

Part A: Lomvastomig 615 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 4 deaths

Part A: Lomvastomig 1200 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 2 deaths

Part A: Lomvastomig 1800 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Part A: Lomvastomig 2100 mg

Serious events: 7 serious events

Other events: 17 other events

Deaths: 13 deaths

Part B1: Metastatic Melanoma Expansion Cohort

Serious events: 6 serious events

Other events: 34 other events

Deaths: 26 deaths

Part B2: NSCLC Expansion Cohort 1

Serious events: 8 serious events

Other events: 24 other events

Deaths: 18 deaths

Part B4: SCLC Expansion Cohort

Serious events: 4 serious events

Other events: 15 other events

Deaths: 13 deaths

Part B5: ESCC Expansion Cohort

Serious events: 10 serious events

Other events: 16 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Lomvastomig 70mg n=3 participants at risk Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 participants at risk Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 participants at risk Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 participants at risk Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 participants at risk Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=19 participants at risk Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort n=38 participants at risk Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 n=26 participants at risk Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=15 participants at risk Participants with CPI-naïve SCLC with prior failure of, progression on, or intolerance to standard therapy received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=16 participants at risk Participants with CPI-naïve ESCC received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Eye disorders Retinopathy	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Colitis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Haematemesis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Obstruction gastric	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Hepatobiliary disorders Cholangitis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Hepatobiliary disorders Cholecystitis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Appendicitis perforated	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Bronchitis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Cellulitis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Gallbladder abscess	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Phlebitis infective	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Pneumonia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	15.8% 3/19 • Number of events 6 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.7% 2/26 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Sepsis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Urinary tract infection	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations False positive investigation result	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Haemoglobin decreased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Troponin T increased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Immune-mediated myositis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Cerebrovascular accident	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders VIth nerve paralysis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Psychiatric disorders Suicide attempt	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Embolism	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Hypertension	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Internal haemorrhage	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.

Other adverse events

Other adverse events
Measure	Part A: Lomvastomig 70mg n=3 participants at risk Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 participants at risk Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 participants at risk Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 participants at risk Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 participants at risk Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=19 participants at risk Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort n=38 participants at risk Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 n=26 participants at risk Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=15 participants at risk Participants with CPI-naïve SCLC with prior failure of, progression on, or intolerance to standard therapy received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=16 participants at risk Participants with CPI-naïve ESCC received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
General disorders Sluggishness	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Endocrine disorders Hyperthyroidism	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 2/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 2/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Secretion discharge	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	31.6% 6/19 • Number of events 10 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.2% 5/38 • Number of events 7 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	23.1% 6/26 • Number of events 7 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 5/15 • Number of events 6 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 2/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Hyperleukocytosis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	15.8% 3/19 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.7% 2/26 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 2/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Cardiac disorders Atrioventricular block first degree	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Cardiac disorders Palpitations	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Cardiac disorders Ventricular arrhythmia	33.3% 1/3 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Endocrine disorders Thyroid disorder	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Eye disorders Diplopia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Eye disorders Dry eye	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Eye disorders Visual impairment	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	15.8% 3/19 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.2% 5/38 • Number of events 7 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.7% 2/26 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	26.7% 4/15 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 2/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.9% 3/38 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Anal fissure	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Ascites	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Change of bowel habit	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Colitis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Constipation	66.7% 2/3 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 2/19 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	18.4% 7/38 • Number of events 8 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	23.1% 6/26 • Number of events 6 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	26.7% 4/15 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	31.2% 5/16 • Number of events 5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Diarrhoea	66.7% 2/3 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	15.8% 3/19 • Number of events 9 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	15.8% 6/38 • Number of events 6 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	37.5% 6/16 • Number of events 8 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Dry mouth	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 2/19 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.7% 2/26 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.7% 2/26 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	18.8% 3/16 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Nausea	100.0% 3/3 • Number of events 5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	21.1% 4/19 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	21.1% 8/38 • Number of events 10 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	11.5% 3/26 • Number of events 6 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	31.2% 5/16 • Number of events 5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Odynophagia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	40.0% 2/5 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 2/19 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	23.7% 9/38 • Number of events 15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	11.5% 3/26 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 2/16 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Asthenia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	50.0% 2/4 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	26.3% 5/19 • Number of events 7 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	42.1% 16/38 • Number of events 20 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	30.8% 8/26 • Number of events 8 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 5/15 • Number of events 5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Chest pain	33.3% 1/3 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Chills	66.7% 2/3 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 2/19 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.7% 2/26 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Fatigue	66.7% 2/3 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	50.0% 2/4 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	15.8% 6/38 • Number of events 8 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	19.2% 5/26 • Number of events 6 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	26.7% 4/15 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	43.8% 7/16 • Number of events 8 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Feeling cold	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Feeling hot	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Inflammation	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Influenza like illness	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Injection site reaction	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Malaise	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Medical device pain	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Mucosal inflammation	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Oedema	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Oedema peripheral	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	15.8% 6/38 • Number of events 7 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Pain	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 2/19 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.7% 2/26 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Pyrexia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	15.8% 3/19 • Number of events 5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 4/38 • Number of events 7 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	23.1% 6/26 • Number of events 6 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 2/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Xerosis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Hepatobiliary disorders Cholestasis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 2/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations COVID-19	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 2/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Candida infection	66.7% 2/3 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Clostridium colitis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Gingivitis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Herpes virus infection	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Infection	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Nasopharyngitis	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Pharyngitis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Pneumonia	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	11.5% 3/26 • Number of events 6 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Respiratory tract infection	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Sinusitis	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Tooth infection	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Urinary tract infection	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 2/19 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	15.4% 4/26 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Injury, poisoning and procedural complications Accidental underdose	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 2/19 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.9% 3/38 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.7% 2/26 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 3/15 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 2/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	21.1% 4/19 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.7% 2/26 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 3/15 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	18.8% 3/16 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.9% 3/38 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Blood bilirubin increased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 2/19 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Blood creatinine increased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 2/19 • Number of events 6 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Blood glucose increased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations C-reactive protein increased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.7% 2/26 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	15.8% 3/19 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.9% 3/38 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	11.5% 3/26 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 2/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Glomerular filtration rate decreased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Haemoglobin decreased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Human chorionic gonadotropin increased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Neutrophil count decreased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Platelet count decreased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Protein total decreased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Troponin increased	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Weight decreased	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	50.0% 2/4 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 4/38 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.7% 2/26 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	31.2% 5/16 • Number of events 5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 2/19 • Number of events 5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	23.7% 9/38 • Number of events 10 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	15.4% 4/26 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	26.7% 4/15 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	18.8% 3/16 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	18.8% 3/16 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 2/19 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 2/19 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.9% 3/38 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 2/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 2/19 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 4/16 • Number of events 5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.7% 2/26 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 4/16 • Number of events 5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Increased appetite	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Arthralgia	66.7% 2/3 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 2/19 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	18.4% 7/38 • Number of events 8 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 2/16 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	15.8% 3/19 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	15.4% 4/26 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	26.7% 4/15 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	50.0% 2/4 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Myalgia	66.7% 2/3 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.7% 2/26 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Sacral pain	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	18.8% 3/16 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Ageusia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Dizziness	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.9% 3/38 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	11.5% 3/26 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Dysarthria	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Somnolence	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.9% 3/38 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Dysgeusia	66.7% 2/3 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Headache	100.0% 3/3 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	26.3% 5/19 • Number of events 5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 4/38 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Dysphonia	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Hypokinesia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Paraesthesia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Peroneal nerve palsy	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Post herpetic neuralgia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Syncope	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Taste disorder	33.3% 1/3 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Psychiatric disorders Anxiety	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	11.5% 3/26 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 2/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Psychiatric disorders Bradyphrenia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Psychiatric disorders Depression	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Psychiatric disorders Insomnia	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 4/38 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	18.8% 3/16 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Psychiatric disorders Restlessness	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Renal and urinary disorders Haematuria	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Renal and urinary disorders Proteinuria	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Renal and urinary disorders Renal colic	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	21.1% 4/19 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	19.2% 5/26 • Number of events 5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	18.8% 3/16 • Number of events 5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Dyspnoea	66.7% 2/3 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	50.0% 2/4 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	50.0% 2/4 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	36.8% 7/19 • Number of events 7 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	10.5% 4/38 • Number of events 6 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	23.1% 6/26 • Number of events 6 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	18.8% 3/16 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	11.5% 3/26 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Painful respiration	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	11.5% 3/26 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pulmonary pain	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Alopecia	66.7% 2/3 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Pruritus	66.7% 2/3 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	40.0% 2/5 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.2% 5/38 • Number of events 6 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	3.8% 1/26 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	26.7% 4/15 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	18.8% 3/16 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	2.6% 1/38 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Rash	66.7% 2/3 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.9% 3/38 • Number of events 5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	11.5% 3/26 • Number of events 3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	18.8% 3/16 • Number of events 4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 2/38 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Embolism	33.3% 1/3 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Flushing	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	5.3% 1/19 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Haematoma	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Hypertension	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	50.0% 2/4 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Hypotension	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 2/16 • Number of events 2 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Lymphoedema	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 1/4 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/16 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Vein disorder	0.00% 0/3 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/4 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/19 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/38 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/26 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.2% 1/16 • Number of events 1 • Part A: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months); Part B: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months) Safety population included all participants who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Part A: Lomvastomig 70 mg n=3 Participants Participants received 70 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 210 mg n=5 Participants Participants received 210 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 615 mg n=4 Participants Participants received 615 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1200 mg n=4 Participants Participants received 1200 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 1800 mg n=4 Participants Participants received 1800 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part A: Lomvastomig 2100 mg n=4 Participants Participants received 2100 mg of lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B1: Metastatic Melanoma Expansion Cohort n=4 Participants Participants with checkpoint inhibitor (CPI) experienced second line and beyond metastatic melanoma received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B2: NSCLC Expansion Cohort 1 n=11 Participants Participants with CPI and platinum experienced second- or third-line programmed death-ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=38 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=25 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B4: SCLC Expansion Cohort n=15 Participants Participants with CPI-naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to standard therapy received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).	Part B5: ESCC Expansion Cohort n=16 Participants Participants with CPI-naïve esophageal squamous cell carcinoma (ESCC) received 2100 mg, lomvastomig, as an IV infusion on Cycle 1 Day 1 and Q2W thereafter until disease progression, unacceptable toxicities, or withdrawal of consent, whichever occurred first (Cycle length = 14 days).
Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig Cycle 5	114 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation could not be calculated.	1200 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 8.0	1120 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 73.6	5470 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 17.3	6620 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 13.6	12200 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation could not be calculated.	13800 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 28.0	14200 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 28.4	11500 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 43.5	11700 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 38.1	9910 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 39.5	11700 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 28.7
Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig Cycle 1	140 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 37.8	426 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 16.0	927 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 28.8	2540 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 22.1	3040 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 31.6	2700 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 52.0	3700 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 26.8	4880 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 30.0	4700 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 27.9	4600 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 27.3	4720 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 25.7	5200 daymicrograms/milliliters (dayµg/mL) Geometric Coefficient of Variation 24.4