Trial Outcomes & Findings for Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma (NCT NCT05525286)

NCT ID: NCT05525286

Last Updated: 2025-11-17

Results Overview

MTD is defined as the highest dose level tested below the dose level associated with ≥33% of dose-limiting toxicity (DLT)-evaluable patients experiencing a DLT. The RP2D will be selected based on evaluation of the totality of all data. The trial was halted early due to safety signals not initially deemed DLTs that were seen across different dose levels. After a protocol amendment formally defined this signal as a DLT, the trial was restarted, but the same safety signal reappeared. Following a review by the independent Dose Escalation Committee, the trial was terminated.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: Through Cycles 1-2 (28 days)
• Results posted on: 2025-11-17

Participant Flow

Participant milestones

Measure	SOT102 as Monotherapy (Part A) DL1 0.032 mg/kg Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.032 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL2 0.064 mg/kg Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.064 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Dose Level 1: 0.032 mg/kg STARTED	4	0	0	0	4
Dose Level 1: 0.032 mg/kg COMPLETED	4	0	0	0	4
Dose Level 1: 0.032 mg/kg NOT COMPLETED	0	0	0	0	0
Dose Level 2: 0.064 mg/kg STARTED	0	11	0	0	0
Dose Level 2: 0.064 mg/kg COMPLETED	0	11	0	0	0
Dose Level 2: 0.064 mg/kg NOT COMPLETED	0	0	0	0	0
Dose Level 3: 0.128 mg/kg STARTED	0	0	9	0	0
Dose Level 3: 0.128 mg/kg COMPLETED	0	0	9	0	0
Dose Level 3: 0.128 mg/kg NOT COMPLETED	0	0	0	0	0
Dose Level 4: 0.214 mg/kg STARTED	0	0	0	3	0
Dose Level 4: 0.214 mg/kg COMPLETED	0	0	0	3	0
Dose Level 4: 0.214 mg/kg NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma

Baseline characteristics by cohort

Measure	SOT102 as Monotherapy (Part A) DL1 0.032 mg/kg n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.032 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL2 0.046 mg/kg n=11 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.064 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=9 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) 0.032 mg/kg n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.032 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=202 Participants	0 Participants n=283 Participants	0 Participants n=120 Participants	0 Participants n=122 Participants	0 Participants n=79 Participants	0 Participants n=806 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=202 Participants	10 Participants n=283 Participants	6 Participants n=120 Participants	1 Participants n=122 Participants	4 Participants n=79 Participants	24 Participants n=806 Participants
Age, Categorical >=65 years	1 Participants n=202 Participants	1 Participants n=283 Participants	3 Participants n=120 Participants	2 Participants n=122 Participants	0 Participants n=79 Participants	7 Participants n=806 Participants
Age, Continuous	55.5 years STANDARD_DEVIATION 6.95 • n=202 Participants	55.4 years STANDARD_DEVIATION 9.62 • n=283 Participants	57.6 years STANDARD_DEVIATION 9.67 • n=120 Participants	65.3 years STANDARD_DEVIATION 2.08 • n=122 Participants	51.8 years STANDARD_DEVIATION 2.63 • n=79 Participants	56.5 years STANDARD_DEVIATION 8.55 • n=806 Participants
Sex: Female, Male Female	1 Participants n=202 Participants	3 Participants n=283 Participants	4 Participants n=120 Participants	2 Participants n=122 Participants	2 Participants n=79 Participants	12 Participants n=806 Participants
Sex: Female, Male Male	3 Participants n=202 Participants	8 Participants n=283 Participants	5 Participants n=120 Participants	1 Participants n=122 Participants	2 Participants n=79 Participants	19 Participants n=806 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=202 Participants	0 Participants n=283 Participants	0 Participants n=120 Participants	0 Participants n=122 Participants	0 Participants n=79 Participants	0 Participants n=806 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=202 Participants	7 Participants n=283 Participants	7 Participants n=120 Participants	1 Participants n=122 Participants	4 Participants n=79 Participants	23 Participants n=806 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=202 Participants	4 Participants n=283 Participants	2 Participants n=120 Participants	2 Participants n=122 Participants	0 Participants n=79 Participants	8 Participants n=806 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=202 Participants	0 Participants n=283 Participants	0 Participants n=120 Participants	0 Participants n=122 Participants	0 Participants n=79 Participants	0 Participants n=806 Participants
Race (NIH/OMB) Asian	0 Participants n=202 Participants	0 Participants n=283 Participants	0 Participants n=120 Participants	0 Participants n=122 Participants	0 Participants n=79 Participants	0 Participants n=806 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=202 Participants	0 Participants n=283 Participants	0 Participants n=120 Participants	0 Participants n=122 Participants	0 Participants n=79 Participants	0 Participants n=806 Participants
Race (NIH/OMB) Black or African American	0 Participants n=202 Participants	0 Participants n=283 Participants	0 Participants n=120 Participants	0 Participants n=122 Participants	0 Participants n=79 Participants	0 Participants n=806 Participants
Race (NIH/OMB) White	4 Participants n=202 Participants	7 Participants n=283 Participants	7 Participants n=120 Participants	1 Participants n=122 Participants	4 Participants n=79 Participants	23 Participants n=806 Participants
Race (NIH/OMB) More than one race	0 Participants n=202 Participants	0 Participants n=283 Participants	0 Participants n=120 Participants	0 Participants n=122 Participants	0 Participants n=79 Participants	0 Participants n=806 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=202 Participants	4 Participants n=283 Participants	2 Participants n=120 Participants	2 Participants n=122 Participants	0 Participants n=79 Participants	8 Participants n=806 Participants
Region of Enrollment Belgium	0 participants n=202 Participants	3 participants n=283 Participants	3 participants n=120 Participants	1 participants n=122 Participants	1 participants n=79 Participants	8 participants n=806 Participants
Region of Enrollment Czechia	2 participants n=202 Participants	0 participants n=283 Participants	3 participants n=120 Participants	0 participants n=122 Participants	3 participants n=79 Participants	8 participants n=806 Participants
Region of Enrollment United States	0 participants n=202 Participants	3 participants n=283 Participants	0 participants n=120 Participants	0 participants n=122 Participants	0 participants n=79 Participants	3 participants n=806 Participants
Region of Enrollment France	0 participants n=202 Participants	3 participants n=283 Participants	1 participants n=120 Participants	1 participants n=122 Participants	0 participants n=79 Participants	5 participants n=806 Participants
Region of Enrollment Spain	2 participants n=202 Participants	2 participants n=283 Participants	2 participants n=120 Participants	1 participants n=122 Participants	0 participants n=79 Participants	7 participants n=806 Participants
ECOG status 0	2 Participants n=202 Participants	4 Participants n=283 Participants	3 Participants n=120 Participants	2 Participants n=122 Participants	2 Participants n=79 Participants	13 Participants n=806 Participants
ECOG status 1	2 Participants n=202 Participants	7 Participants n=283 Participants	6 Participants n=120 Participants	1 Participants n=122 Participants	2 Participants n=79 Participants	18 Participants n=806 Participants
Weight at baseline	77.8 kilograms STANDARD_DEVIATION 16.58 • n=202 Participants	75.5 kilograms STANDARD_DEVIATION 22.3 • n=283 Participants	72.7 kilograms STANDARD_DEVIATION 18.08 • n=120 Participants	62.7 kilograms STANDARD_DEVIATION 21.02 • n=122 Participants	72.4 kilograms STANDARD_DEVIATION 19.54 • n=79 Participants	73.4 kilograms STANDARD_DEVIATION 19.08 • n=806 Participants
Height at baseline	1.74 meters STANDARD_DEVIATION 0.12 • n=202 Participants	1.74 meters STANDARD_DEVIATION 0.135 • n=283 Participants	1.73 meters STANDARD_DEVIATION 0.107 • n=120 Participants	1.67 meters STANDARD_DEVIATION 0.195 • n=122 Participants	1.69 meters STANDARD_DEVIATION 0.101 • n=79 Participants	1.72 meters STANDARD_DEVIATION 0.121 • n=806 Participants
BSA at baseline	1.90 square meters STANDARD_DEVIATION 0.271 • n=202 Participants	1.89 square meters STANDARD_DEVIATION 0.311 • n=283 Participants	1.86 square meters STANDARD_DEVIATION 0.288 • n=120 Participants	1.67 square meters STANDARD_DEVIATION 0.379 • n=122 Participants	1.83 square meters STANDARD_DEVIATION 0.263 • n=79 Participants	1.86 square meters STANDARD_DEVIATION 0.287 • n=806 Participants

PRIMARY outcome

Timeframe: Through Cycles 1-2 (28 days)

Population: DLT evaluable patients were those who have received 2 doses of SOT102 per schedule (day 1 of cycle 1 and day 1 of cycle 2) with the maximum postponement of cycle 2 by 1 day (as agreed by the sponsor) and completed the evaluation period of 28 days. Also patients who experienced a treatment emergent adverse event at any time during the DLT evaluation period that met the definition of a DLT.

MTD is defined as the highest dose level tested below the dose level associated with ≥33% of dose-limiting toxicity (DLT)-evaluable patients experiencing a DLT. The RP2D will be selected based on evaluation of the totality of all data. The trial was halted early due to safety signals not initially deemed DLTs that were seen across different dose levels. After a protocol amendment formally defined this signal as a DLT, the trial was restarted, but the same safety signal reappeared. Following a review by the independent Dose Escalation Committee, the trial was terminated.

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=20 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=1 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B: The Definition of the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of SOT102 Given as Monotherapy and in Combination With First-line SoC Treatment	NA Participants The protocol-defined MTD was never reached, since ≥33% of patients never had a DLT at any given dose level	NA Participants The protocol-defined MTD was never reached, since ≥33% of patients never had a DLT at any given dose level	—	—	—

PRIMARY outcome

Timeframe: From Day 1 of Cycle 1 until disease progression or start of new anticancer therapy, whichever is first, to be assessed up to approximately 4 years

Population: Part C and Part D were not initiated, no population was analyzed.

Efficacy is determined by objective response rate (ORR) determined according to RECIST 1.1 criteria

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through Cycles 1-2 (28 days)

Population: Patients who received 2 doses of SOT102 per schedule (day 1 of cycle 1 and day 1 of cycle 2). Patients must have completed evaluation period of 28 days. Pancreatic patients must have received three doses of SoC (days 1, 8, and 15 of cycle 1), gastric patients must have received 2 doses of SoC per schedule (day 1 of cycle 1 and day 1 of cycle 2). Patients who experienced an adverse event at any time during the DLT evaluation period that met the definition of a DLT were included.

Adverse events (AEs) graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 considered DLTs: All grade 5 events not clearly related to disease progression or any other causes; Any grade 3 or higher non-hematologic toxicity regardless of duration; Grade 2 or higher serum creatinine elevation; Hy's law cases; Any grade 2 pneumonitis that does not resolve to grade 1 within 3 days of the initiation of maximal supportive care; Recurrent grade 2 pneumonitis; Grade 2 or higher proteinuria; Grade 4 neutropenia lasting more than 7 days; Febrile neutropenia; Grade 3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia. AEs NOT considered DLTs: Grade 3 nausea, vomiting, or diarrhea that can be controlled within 72 hours; Grade 3 fatigue less than 5 days; Grade 3 or higher correctable electrolyte abnormalities that last less than 72 hours and not associated with clinical complications; Grade 3 or higher amylase or lipase

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=8 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=6 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=1 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B (Monotherapy and Combination With SoC): Number of Participants With DLTs	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 up to approximately 2 years and 8.5 months

Population: Patients exposed to at least one dose of SOT102

A TEAE is defined as an AE that:

• emerges during SOT102 treatment, having been absent at the time of pre-treatment (screening), or
• re-emerges during SOT102 treatment, having been present at the time of pre-treatment (screening), or
• worsens in severity during SOT102 treatment relative to the pre-treatment state if the AE is continuous.

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=11 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=9 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B (Monotherapy and Combination With SoC): Number of Participants With Treatment-emergent AEs (TEAEs)	4 Participants	10 Participants	9 Participants	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 1 up to approximately 2 years and 8.5 months

Population: Patients exposed to at least one dose of SOT102

Causal relationship (relatedness) of all AEs will be assessed by investigators and classified as follows:

• Not suspected: It is not plausible that the AE is caused by medication/procedure and a likely alternative explanation exists. No reasonable possibility of a causal or temporal relationship.
• Suspected: It is plausible that the AE is caused by medication/procedure. Reasonable possibility of a causal relationship.

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=11 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=9 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B (Monotherapy and Combination With SoC): Number of Participants With SOT102-related AEs	3 Participants	4 Participants	6 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1 up to approximately 2 years and 8.5 months

Population: Patients exposed to at least one dose of SoC

Causal relationship (relatedness) of all AEs will be assessed by investigators and classified as follows:

• Not suspected: It is not plausible that the AE is caused by medication/procedure and a likely alternative explanation exists. No reasonable possibility of a causal or temporal relationship.
• Suspected: It is plausible that the AE is caused by medication/procedure. Reasonable possibility of a causal relationship.

Outcome measures

Measure	SOT102 as Monotherapy (Part A) Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Part B (Combination With SoC): Number of Participants With SoC-related AEs	—	—	—	—	4 Participants

SECONDARY outcome

Timeframe: Day 1 up to approximately 2 years and 8.5 months

Population: Patients exposed to at least one dose of SOT102

An SAE is any untoward medical occurrence that at any dose fulfills one or more of the following criteria:

• Results in death
• Is immediately life-threatening
• Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect
• Requires inpatient hospitalization or prolongation of existing hospitalization
• Is another medically significant event defined as an event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent any of the above listed outcomes

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=11 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=9 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B (Monotherapy and Combination With SoC): Number of Participants With Serious AEs (SAEs)	4 Participants	5 Participants	5 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 up to approximately 2 years and 8.5 months

Population: Patients exposed to at least one dose of SOT102

AEs (intercurrent illness or trial treatment-related toxicity) that would, in the judgment of the investigator, affect assessments of clinical status to a significant degree or require discontinuation of trial treatment

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=11 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=9 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B (Monotherapy and Combination With SoC): Number of Participants With AEs Leading to Premature Discontinuation of SOT102	0 Participants	1 Participants	3 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 up to approximately 2 years and 8.5 months

Population: Patients exposed to at least one dose of SoC

AEs (intercurrent illness or trial treatment-related toxicity) that would, in the judgment of the investigator, affect assessments of clinical status to a significant degree or require discontinuation of trial treatment

Outcome measures

Measure	SOT102 as Monotherapy (Part A) Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Part B (Combination With SoC): Number of Participants With AEs Leading to Premature Discontinuation of SoC	—	—	—	—	1 Participants

SECONDARY outcome

Timeframe: Day 1 up to approximately 2 years and 8.5 months

Population: Patients exposed to at least one dose of SOT102

Date of death and immediate and underlying causes of death will be collected.

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=11 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=9 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B (Monotherapy and Combination With SoC): Number of Participants Who Died	2 Participants	5 Participants	3 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 up to approximately 2 years and 8.5 months

Population: Patients exposed to at least one dose of SOT102

The following laboratory parameters will be assessed:

• Coagulation: prothrombin time, INR
• Hematology: leukocytes, erythrocytes, hemoglobin, hematocrit, platelets, differential
• Clinical chemistry: ALT, albumin, ALP, amylase, AST, bilirubin, blood urea nitrogen or blood urea, calcium, creatinine, glucose (fasting), LDH, lipase, magnesium, potassium, sodium, TSH (gastric adenocarcinoma only)
• Urinalysis: blood, glucose, ketones, pH, protein, specific gravity, urine leukocyte esterase

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=11 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=9 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B (Monotherapy and Combination With SoC): Number of Participants With Clinical Laboratory Test Abnormalities (Coagulation, Hematology, Clinical Chemistry and Urinalysis) of Grade 3 or Higher Graded According to NCI CTCAE Version 5.0	3 Participants	2 Participants	3 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 of Cycle 1 until Day 1 of Cycle 5

Population: Patients who had at least 1 post-dose concentration measurement above the lower limit of quantification. No data was collected for Part B due to the low number of patients.

Assessment of concentration of SOT102 and its derivates at various timepoints

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=10 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=9 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B (Monotherapy and Combination With SoC): Characterization of Cmax of SOT102	564.1750 ng/mL Interval 278.99 to 839.6	1220.3250 ng/mL Interval 853.4 to 2308.8	2792.6000 ng/mL Interval 281.06 to 3630.4	4980.6000 ng/mL Interval 3304.2 to 6304.0	—

SECONDARY outcome

Timeframe: From Day 1 of Cycle 1 until Day 1 of Cycle 5

Population: Patients who had at least 1 post-dose concentration measurement above the lower limit of quantification. No data was collected for Part B due to the low number of patients.

Assessment of concentration of SOT102 and its derivates at various timepoints

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=10 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=9 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B (Monotherapy and Combination With SoC): Characterization of Tmax of SOT102	0.217 hours Interval 0.17 to 3.02	0.217 hours Interval 0.02 to 22.8	0.233 hours Interval 0.02 to 3.13	0.233 hours Interval 0.22 to 0.25	—

SECONDARY outcome

Timeframe: From Day 1 of Cycle 1 until Day 1 of Cycle 5

Population: Patients who had at least 1 post-dose concentration measurement above the lower limit of quantification. No data was collected for Part B due to the low number of patients.

Assessment of concentration of SOT102 and its derivates at various timepoints

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=10 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=9 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B (Monotherapy and Combination With SoC): Characterization of AUClast of SOT102	44558.9495 h*ng/mL Interval 26130.047 to 72331.081	108104.0701 h*ng/mL Interval 37856.444 to 329008.958	321146.7316 h*ng/mL Interval 14143.478 to 458598.933	605136.8688 h*ng/mL Interval 461829.806 to 812024.2	—

SECONDARY outcome

Timeframe: From Day 1 of Cycle 1 until disease progression or start of new anticancer therapy, whichever is first, assessed up to approximately 2 years and 9 months

Population: Patients exposed to at least one dose of SOT102 who had at least one evaluable tumor assessment per RECIST v1.1 after the initiation of SOT102 treatment

Detection of anecdotal tumor response in individual patient, as per RECIST 1.1 criteria

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=2 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=9 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=8 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B (Monotherapy and Combination With SoC): Evidence of SOT102 Activity in Monotherapy in Individual Patients - BOR: Complete Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 of Cycle 1 until disease progression or start of new anticancer therapy, whichever is first, assessed up to approximately 2 years and 9 months

Population: Patients exposed to at least one dose of SOT102 who had at least one evaluable tumor assessment per RECIST v1.1 after the initiation of SOT102 treatment

Detection of anecdotal tumor response in individual patient, as per RECIST 1.1 criteria

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=2 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=9 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=8 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B (Monotherapy and Combination With SoC): Evidence of SOT102 Activity in Monotherapy in Individual Patients - BOR: Partial Response	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 of Cycle 1 until disease progression or start of new anticancer therapy, whichever is first, assessed up to approximately 2 years and 9 months

Population: Patients exposed to at least one dose of SOT102 who had at least one evaluable tumor assessment per RECIST v1.1 after the initiation of SOT102 treatment

Detection of anecdotal tumor response in individual patient, as per RECIST 1.1 criteria

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=2 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=9 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=8 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B (Monotherapy and Combination With SoC): Evidence of SOT102 Activity in Monotherapy in Individual Patients - BOR: Stable Disease	1 Participants	3 Participants	2 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: From Day 1 of Cycle 1 until disease progression or start of new anticancer therapy, whichever is first, assessed up to approximately 2 years and 9 months

Population: Patients exposed to at least one dose of SOT102 who had at least one evaluable tumor assessment per RECIST v1.1 after the initiation of SOT102 treatment

Detection of anecdotal tumor response in individual patient, as per RECIST 1.1 criteria

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=2 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=9 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=8 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B (Monotherapy and Combination With SoC): Evidence of SOT102 Activity in Monotherapy in Individual Patients - BOR: Progressive Disease	1 Participants	5 Participants	6 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 of Cycle 1 until 30 (+5) days after the last dose of SOT102, assessed up to approximately 2 years and 9 months

Population: Patients exposed to at least one dose of SOT102

Identification of patients who develop detectable antibodies against any part of SOT102

Outcome measures

Measure	SOT102 as Monotherapy (Part A) n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) n=11 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=9 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=4 Participants Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Parts A and B (Monotherapy and Combination With SoC): Number of Participants With Antibodies Against SOT102	3 Participants	2 Participants	3 Participants	0 Participants	0 Participants

Adverse Events

SOT102 as Monotherapy (Part A) DL1 0.032 mg/kg

Serious events: 4 serious events

Other events: 4 other events

Deaths: 2 deaths

SOT102 as Monotherapy (Part A) DL2 0.064 mg/kg

Serious events: 5 serious events

Other events: 9 other events

Deaths: 5 deaths

SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg

Serious events: 5 serious events

Other events: 8 other events

Deaths: 3 deaths

SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	SOT102 as Monotherapy (Part A) DL1 0.032 mg/kg n=4 participants at risk Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.032 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL2 0.064 mg/kg n=11 participants at risk Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.064 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=9 participants at risk Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 participants at risk Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=4 participants at risk Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Renal and urinary disorders Focal segmental glomerulosclerosis	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Renal and urinary disorders Nephroangiosclerosis	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	33.3% 1/3 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Hepatobiliary disorders Cholangitis	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	9.1% 1/11 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Hepatobiliary disorders Jaundice cholestatic	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Infections and infestations Bacterial sepsis	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Infections and infestations Biliary tract infection	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Infections and infestations Sepsis	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Metabolism and nutrition disorders Hypercalcaemia	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	9.1% 1/11 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
General disorders General physical health deterioration	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Investigations Blood bilirubin increased	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	9.1% 1/11 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	9.1% 1/11 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Vascular disorders Embolism	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	9.1% 1/11 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	33.3% 1/3 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Gastrointestinal disorders Gastric ulcer	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Gastrointestinal disorders Intestinal obstruction	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Gastrointestinal disorders Oesophageal obstruction	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	33.3% 1/3 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Gastrointestinal disorders Vomiting	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Renal and urinary disorders Protoeinuria	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	9.1% 1/11 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	33.3% 1/3 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators

Other adverse events

Measure	SOT102 as Monotherapy (Part A) DL1 0.032 mg/kg n=4 participants at risk Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.032 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL2 0.064 mg/kg n=11 participants at risk Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.064 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg n=9 participants at risk Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg n=3 participants at risk Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.	SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg n=4 participants at risk Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.
Renal and urinary disorders Proteinuria	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	33.3% 3/9 • Number of events 3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	27.3% 3/11 • Number of events 3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	33.3% 1/3 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	18.2% 2/11 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
General disorders Pain	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	33.3% 1/3 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Blood and lymphatic system disorders Anaemia	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	18.2% 2/11 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	50.0% 2/4 • Number of events 4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Blood and lymphatic system disorders Neutrophil count decreased	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	100.0% 4/4 • Number of events 13 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Blood and lymphatic system disorders Platelet count decreased	25.0% 1/4 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	100.0% 4/4 • Number of events 12 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Number of events 3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	18.2% 2/11 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	25.0% 1/4 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Gastrointestinal disorders Ascites	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Gastrointestinal disorders Constipation	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	18.2% 2/11 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Gastrointestinal disorders Diarrhoea	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	25.0% 1/4 • Number of events 3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	9.1% 1/11 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Gastrointestinal disorders Nausea	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	36.4% 4/11 • Number of events 4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	33.3% 3/9 • Number of events 3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	100.0% 4/4 • Number of events 8 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	9.1% 1/11 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	50.0% 2/4 • Number of events 3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
General disorders Fatigue	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	27.3% 3/11 • Number of events 3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	44.4% 4/9 • Number of events 4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	66.7% 2/3 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	100.0% 4/4 • Number of events 7 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
General disorders Pyrexia	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	25.0% 1/4 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Hepatobiliary disorders Alanine aminotransferase increased	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	9.1% 1/11 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	50.0% 2/4 • Number of events 5 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Hepatobiliary disorders Aspartate aminotransferase increased	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	9.1% 1/11 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	50.0% 2/4 • Number of events 4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Hepatobiliary disorders Blood bilirubin increased	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	27.3% 3/11 • Number of events 3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Investigations Amylase increased	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	33.3% 1/3 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Investigations Blood creatinine increased	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	9.1% 1/11 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Investigations C-reactive protein increased	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	22.2% 2/9 • Number of events 3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Investigations Lipase increased	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Metabolism and nutrition disorders Decreased appetite	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	9.1% 1/11 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	33.3% 1/3 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	100.0% 4/4 • Number of events 6 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	9.1% 1/11 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	33.3% 1/3 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Musculoskeletal and connective tissue disorders Back pain	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	22.2% 2/9 • Number of events 3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	9.1% 1/11 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	33.3% 1/3 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Nervous system disorders Headache	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	9.1% 1/11 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/9 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
Renal and urinary disorders Acute kidney injury	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/11 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/3 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators	0.00% 0/4 • Day 1 up to approximately 2 years and 8.5 months Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators

Additional Information

Richard Kapsa

SOTIO Biotech a.s.

Phone: (+420) 2241 74448

Email: kapsa@sotio.com

Results disclosure agreements

• Principal investigator is a sponsor employee The results will be published and/or presented at scientific meetings in their totality in a timely manner. Any formal publication of clinical trial results will be a collaborative effort between the sponsor and the investigator(s). All manuscripts or abstracts will be reviewed and approved in written by the sponsor before submission. The sponsor may request a delay in publication if there are important intellectual property concerns.
• Publication restrictions are in place

Restriction type: OTHER