Trial Outcomes & Findings for A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors (NCT NCT05091346)

Last Updated: 2025-10-24

Results Overview

DLT was graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 based on investigator assessment. DLT was defined as any of the hematological or non-hematological toxicities events that: - Failure to administer greater than or equal to (\>=) 75 percentage (%) of the planned dosage of E7386 as a result of treatment-related toxicity; - Any treatment-related toxicity that causes the participant to discontinue treatment, even if the toxicity does not meet DLT criteria; - Prolonged delay (greater than \[\>\] 2 weeks) in initiating Cycle 2 due to treatment-related toxicities; - Any Grade 5 event or any death not clearly due to the underlying disease or extraneous causes.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

89 participants

Primary outcome timeframe

Cycle 1 (Cycle length=21 days)

Results posted on

2025-10-24

Participant Flow

Participants took part in the study at 25 investigative sites in Japan, United States, Spain, and United Kingdom from 27 October 2021 to 15 October 2024.

A total of 152 participants were screened, of which 63 were screen failures and 89 received study treatment.

Participant milestones

Participant milestones
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg Participants received E7386 100 milligrams (mg), tablets, orally, twice daily (BID), plus pembrolizumab 200 mg, intravenous (IV) infusion, every 3 weeks (Q3W) continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg Participants with hepatocellular carcinoma (HCC) received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with colorectal cancer (CRC) received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Overall Study COMPLETED	0	0	0	0	0
Overall Study STARTED	6	6	17	29	31
Overall Study NOT COMPLETED	6	6	17	29	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg Participants received E7386 100 milligrams (mg), tablets, orally, twice daily (BID), plus pembrolizumab 200 mg, intravenous (IV) infusion, every 3 weeks (Q3W) continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg Participants with hepatocellular carcinoma (HCC) received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with colorectal cancer (CRC) received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Overall Study Survival follow-up ceased/discontinued by sponsor	0	0	7	10	4
Overall Study Death	6	5	8	16	26
Overall Study Lost to Follow-up	0	0	0	1	0
Overall Study Withdrawal by Subject	0	1	2	2	1

Baseline Characteristics

A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg n=17 Participants Participants with HCC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg n=29 Participants Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg n=31 Participants Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Total n=89 Participants Total of all reporting groups
Age, Continuous	64.8 years STANDARD_DEVIATION 8.38 • n=5 Participants	63.3 years STANDARD_DEVIATION 14.00 • n=7 Participants	66.4 years STANDARD_DEVIATION 12.52 • n=5 Participants	60.8 years STANDARD_DEVIATION 11.16 • n=4 Participants	55.5 years STANDARD_DEVIATION 11.20 • n=21 Participants	60.5 years STANDARD_DEVIATION 11.98 • n=10 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	12 Participants n=21 Participants	35 Participants n=10 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants	19 Participants n=4 Participants	19 Participants n=21 Participants	54 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants	27 Participants n=4 Participants	29 Participants n=21 Participants	84 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	12 Participants n=21 Participants	34 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=10 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	10 Participants n=5 Participants	23 Participants n=4 Participants	14 Participants n=21 Participants	47 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Cycle length=21 days)

Population: The DLT Analysis Set included all participants in Phase 1b part who had received study drug as planned (that is \[i.e.\], complete at least 75% of the planned E7386) in Cycle 1, or who experienced a DLT.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Phase 1b Part: Number of Participants With Dose-limiting Toxicities (DLTs)	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Up to 30 days after last dose of study drug (up to 12.73 months)

Population: Safety Analysis Set included all participants who received at least 1 dose of any study drug.

A TEAE was defined as an adverse event (AE) that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, or up to 30 days following last dose of study drug, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment or up to 30 days following last dose of study drug, relative to the pretreatment state, when the AE was continuous.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Phase 1b Part: Number of Participants With Treatment Emergent Adverse Events (TEAEs)	6 Participants	6 Participants	—	—	—

PRIMARY outcome

Timeframe: Up to 90 days after last dose of study drug (up to 14.73 months)

Population: Safety Analysis Set included all participants who received at least 1 dose of any study drug.

An SAE was any untoward medical occurrence that at any dose: Resulted in death; Was life-threatening (i.e., the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); Required inpatient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). An SAE was also counted as a TEAE if it emerged up to 90 days after the participant's last dose of study drug, or up to 30 days following cessation of study drug if the participant initiated new anticancer therapy, whichever was earlier.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Phase 1b Part: Number of Participants With Serious TEAEs	0 Participants	2 Participants	—	—	—

PRIMARY outcome

Timeframe: Up to 20.40 months

Population: Efficacy Analysis Set included all participants with measurable disease at Baseline who received at least 1 dose of any study drug.

ORR was defined as the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to less than \[\<\] 10 millimeters \[mm\]). PR: At least a 30 percent (%) decrease in sum of the diameters (SOD) of target lesions, taking as reference the screening SOD. Additionally, progression of target lesions must not be present.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg n=17 Participants Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg n=29 Participants Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg n=31 Participants Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Phase 2 Part: Objective Response Rate (ORR)	0.0 percentage of participants Interval 0.0 to 19.5	6.9 percentage of participants Interval 0.8 to 22.8	3.2 percentage of participants Interval 0.1 to 16.7	—	—

SECONDARY outcome

Timeframe: Up to 11.73 months

Population: Efficacy Analysis Set included all participants with measurable disease at Baseline who received at least 1 dose of any study drug.

BOR was defined as CR, PR, stable disease (SD), progressive disease (PD), and not applicable (NA)/not evaluable (NE) as per RECIST version 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to \<10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient increase to qualify for PD. PD: At least a 20% increase in the SOD of target lesions, taking as reference nadir SOD (or the screening, if screening is nadir value). In addition to relative increase of 20% in SOD, the SOD must also demonstrate an absolute increase of \>=5 mm. NA: No target lesions were identified at Screening.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Phase 1b Part: Percentage of Participants With Best Overall Response (BOR) CR	0 percentage of participants	0 percentage of participants	—	—	—
Phase 1b Part: Percentage of Participants With Best Overall Response (BOR) PR	0 percentage of participants	0 percentage of participants	—	—	—
Phase 1b Part: Percentage of Participants With Best Overall Response (BOR) SD	83.3 percentage of participants	33.3 percentage of participants	—	—	—
Phase 1b Part: Percentage of Participants With Best Overall Response (BOR) PD	16.7 percentage of participants	50.0 percentage of participants	—	—	—
Phase 1b Part: Percentage of Participants With Best Overall Response (BOR) NA/NE	0 percentage of participants	16.7 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Phase 1b Part: Up to 11.73 months; Phase 2 Part: Up to 20.40 months

Population: Efficacy Analysis Set included all participants with measurable disease at Baseline who received at least 1 dose of any study drug. Here, "Overall Number of Participants Analyzed" signifies participants who had CR or PR.

DOR was defined as the time from the first documentation of CR or PR to the first documentation of PD or death due to any cause (whichever occurs first), in participants with confirmed CR or PR per RECIST 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to \<10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient increase to qualify for PD. PD: At least a 20% increase in the SOD of target lesions, taking as reference nadir SOD (or the screening, if screening is nadir value). In addition to relative increase of 20% in SOD, the SOD must also demonstrate an absolute increase of \>=5 mm.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg n=2 Participants Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg n=1 Participants Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Phase 1b and Phase 2 Parts: Duration of Response (DOR)	—	—	—	14.1 months Interval 12.4 to Here, "NA" means upper limit of confidence interval could not be estimated due to low number participants with events.	7.5 months Here, "NA" means upper and lower limit of confidence interval could not be estimated due to low number participants with events.

SECONDARY outcome

Timeframe: Phase 1b Part: Up to 11.73 months; Phase 2 Part: Up to 20.40 months

Population: Efficacy Analysis Set included all participants with measurable disease at Baseline who received at least 1 dose of any study drug.

DCR was defined as the percentage of participants who had a best overall response of confirmed CR or PR, or SD (after \>=5 weeks from the first dose) as per RECIST 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to \<10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient increase to qualify for PD. PD: At least a 20% increase in the SOD of target lesions, taking as reference nadir SOD (or the screening, if screening is nadir value). In addition to relative increase of 20% in SOD, the SOD must also demonstrate an absolute increase of \>=5 mm.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg n=17 Participants Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg n=29 Participants Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg n=31 Participants Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Phase 1b and Phase 2 Parts: Disease Control Rate (DCR)	83.3 percentage of participants Interval 35.9 to 99.6	33.3 percentage of participants Interval 4.3 to 77.7	58.8 percentage of participants Interval 32.9 to 81.6	48.3 percentage of participants Interval 29.4 to 67.5	32.3 percentage of participants Interval 16.7 to 51.4

SECONDARY outcome

Timeframe: Phase 1b Part: Up to 11.73 months; Phase 2 Part: Up to 20.40 months

Population: Efficacy Analysis Set included all participants with measurable disease at Baseline who received at least 1 dose of any study drug.

CBR was defined as the percentage of participants who had a best overall response of confirmed CR or PR, or durable SD (duration of SD \>=23 weeks) per RECIST 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to \<10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient increase to qualify for PD.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg n=17 Participants Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg n=29 Participants Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg n=31 Participants Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Phase 1b and Phase 2 Parts: Clinical Benefit Rate (CBR)	16.7 percentage of participants Interval 0.4 to 64.1	16.7 percentage of participants Interval 0.4 to 64.1	11.8 percentage of participants Interval 1.5 to 36.4	13.8 percentage of participants Interval 3.9 to 31.7	16.1 percentage of participants Interval 5.5 to 33.7

SECONDARY outcome

Timeframe: Up to 30 days after last dose of study drug (up to 21.40 months)

Population: Safety Analysis Set included all participants who received at least 1 dose of any study drug.

A TEAE was defined as an AE that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, or up to 30 days following last dose of study drug, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment or up to 30 days following last dose of study drug, relative to the pretreatment state, when the AE was continuous. Related TEAEs was defined as AE for which a causal relationship between the study drug and the AE was a reasonable possibility.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg n=17 Participants Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg n=29 Participants Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg n=31 Participants Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Phase 2 Part: Number of Participants With TEAEs and Treatment-related TEAEs TEAEs	17 Participants	28 Participants	30 Participants	—	—
Phase 2 Part: Number of Participants With TEAEs and Treatment-related TEAEs Treatment Related TEAEs	16 Participants	26 Participants	28 Participants	—	—

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 8: Pre-dose up to 12 hours post-dose (Cycle 1 length=21 days)

Population: Pharmacokinetic Analysis Set included all participants who had received at least 1 dose of study drug and had at least 1 evaluable plasma E7386 concentration. As planned, this PK parameter was assessed in Phase 1b Part only.

Cmax was defined as the maximum plasma concentration for E7386 when co-administered with Pembrolizumab. PK parameters were derived by noncompartmental analysis.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Phase 1b Part, Cmax: Maximum Observed Plasma Concentration for E7386 When Co-administered With Pembrolizumab Cycle 1 Day 1	401 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 232.0	472 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 82.1	—	—	—
Phase 1b Part, Cmax: Maximum Observed Plasma Concentration for E7386 When Co-administered With Pembrolizumab Cycle 1 Day 8	386 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 240.0	706 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 86.4	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 8: Pre-dose up to 12 hours post-dose (Cycle 1 length=21 days)

Tmax was defined as the time to reach maximum observed plasma concentration for E7386 when co-administered with Pembrolizumab. PK parameters were derived by noncompartmental analysis.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Phase 1b Part, Tmax: Time to Reach the Maximum Plasma Concentration for E7386 When Co-administered With Pembrolizumab Cycle 1 Day 8	2.90 hour Interval 1.9 to 3.93	1.38 hour Interval 0.55 to 6.0	—	—	—
Phase 1b Part, Tmax: Time to Reach the Maximum Plasma Concentration for E7386 When Co-administered With Pembrolizumab Cycle 1 Day 1	0.70 hour Interval 0.35 to 5.93	2.00 hour Interval 0.53 to 2.05	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 8: Pre-dose up to 12 hours post-dose (Cycle 1 length=21 days)

AUC(0-t) was defined as the area under the plasma concentration-time curve from 0 (pre-dose) to time of last quantifiable concentration for E7386 when co-administered with Pembrolizumab. PK parameters were derived by noncompartmental analysis.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Phase 1b Part, AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E7386 When Co-administered With Pembrolizumab Cycle 1 Day 1	874 nanogramhour per milliliter (ngh/mL) Geometric Coefficient of Variation 192.0	1400 nanogramhour per milliliter (ngh/mL) Geometric Coefficient of Variation 52.5	—	—	—
Phase 1b Part, AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E7386 When Co-administered With Pembrolizumab Cycle 1 Day 8	1830 nanogramhour per milliliter (ngh/mL) Geometric Coefficient of Variation 180.0	2540 nanogramhour per milliliter (ngh/mL) Geometric Coefficient of Variation 81.3	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 8: Pre-dose up to 12 hours post-dose (Cycle 1 length=21 days)

CLss/F for E7386 when co-administered with Pembrolizumab was reported. PK parameters were derived by noncompartmental analysis.

Outcome measures

Outcome measures
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg n=6 Participants Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Phase 1b Part, CLss/F: Apparent Clearance From Plasma at Steady State for E7386 When Co-administered With Pembrolizumab	54.0 liter per hour Geometric Coefficient of Variation 181.0	46.9 liter per hour Geometric Coefficient of Variation 80.7	—	—	—

Adverse Events

Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 6 deaths

Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 5 deaths

Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg

Serious events: 7 serious events

Other events: 17 other events

Deaths: 8 deaths

Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg

Serious events: 5 serious events

Other events: 28 other events

Deaths: 16 deaths

Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg

Serious events: 10 serious events

Other events: 30 other events

Deaths: 26 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg n=6 participants at risk Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg n=6 participants at risk Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg n=17 participants at risk Participants with HCC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg n=29 participants at risk Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg n=31 participants at risk Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Gastrointestinal disorders Dysphagia	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/31 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Gastrointestinal disorders Intestinal obstruction	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/31 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/31 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
General disorders General physical health deterioration	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
General disorders Malaise	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
General disorders Organ failure	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/31 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
General disorders Pyrexia	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	6.9% 2/29 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/31 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/31 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Hepatobiliary disorders Hepatic haemorrhage	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.4% 1/29 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/31 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Infections and infestations Sepsis	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.4% 1/29 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Infections and infestations Septic shock	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/31 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Infections and infestations Urosepsis	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Investigations Liver function test abnormal	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	16.7% 1/6 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/31 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	16.7% 1/6 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/31 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Nervous system disorders Brain oedema	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Nervous system disorders Cerebrovascular accident	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Renal and urinary disorders Urinary tract obstruction	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.4% 1/29 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/31 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Vascular disorders Hypotension	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/31 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)

Other adverse events

Other adverse events
Measure	Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg n=6 participants at risk Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg n=6 participants at risk Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg n=17 participants at risk Participants with HCC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg n=29 participants at risk Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.	Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg n=31 participants at risk Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
Metabolism and nutrition disorders Decreased appetite	33.3% 2/6 • Number of events 4 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	17.6% 3/17 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	24.1% 7/29 • Number of events 14 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	32.3% 10/31 • Number of events 12 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	11.8% 2/17 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	13.8% 4/29 • Number of events 5 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 2/6 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	29.4% 5/17 • Number of events 5 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	12.9% 4/31 • Number of events 4 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Blood and lymphatic system disorders Anaemia	33.3% 2/6 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	29.4% 5/17 • Number of events 8 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	20.7% 6/29 • Number of events 20 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	25.8% 8/31 • Number of events 8 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	17.6% 3/17 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.4% 1/29 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	29.0% 9/31 • Number of events 9 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	17.6% 3/17 • Number of events 6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	17.2% 5/29 • Number of events 5 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	9.7% 3/31 • Number of events 6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Gastrointestinal disorders Constipation	33.3% 2/6 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	41.2% 7/17 • Number of events 12 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	34.5% 10/29 • Number of events 14 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	22.6% 7/31 • Number of events 7 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	33.3% 2/6 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	47.1% 8/17 • Number of events 10 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	31.0% 9/29 • Number of events 17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	19.4% 6/31 • Number of events 8 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Gastrointestinal disorders Dry mouth	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	10.3% 3/29 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	6.5% 2/31 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Gastrointestinal disorders Nausea	100.0% 6/6 • Number of events 8 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	66.7% 4/6 • Number of events 5 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	88.2% 15/17 • Number of events 30 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	62.1% 18/29 • Number of events 35 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	61.3% 19/31 • Number of events 27 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Gastrointestinal disorders Vomiting	66.7% 4/6 • Number of events 11 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	83.3% 5/6 • Number of events 7 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	70.6% 12/17 • Number of events 30 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	75.9% 22/29 • Number of events 49 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	58.1% 18/31 • Number of events 36 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
General disorders Asthenia	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	23.5% 4/17 • Number of events 7 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	34.5% 10/29 • Number of events 16 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	9.7% 3/31 • Number of events 4 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
General disorders Fatigue	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	11.8% 2/17 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	17.2% 5/29 • Number of events 7 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	22.6% 7/31 • Number of events 17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
General disorders Malaise	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	33.3% 2/6 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	17.6% 3/17 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.4% 1/29 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	9.7% 3/31 • Number of events 4 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
General disorders Oedema peripheral	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	11.8% 2/17 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/29 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	6.5% 2/31 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
General disorders Pyrexia	16.7% 1/6 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	16.7% 1/6 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	6.9% 2/29 • Number of events 4 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	19.4% 6/31 • Number of events 9 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Investigations Alanine aminotransferase increased	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	23.5% 4/17 • Number of events 6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	13.8% 4/29 • Number of events 4 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Investigations Aspartate aminotransferase increased	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	29.4% 5/17 • Number of events 7 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	13.8% 4/29 • Number of events 4 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	9.7% 3/31 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Investigations Blood alkaline phosphatase increased	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	6.9% 2/29 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	12.9% 4/31 • Number of events 7 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Investigations Blood bilirubin increased	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	23.5% 4/17 • Number of events 6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.4% 1/29 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	9.7% 3/31 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Investigations Blood creatinine increased	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	6.9% 2/29 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	6.5% 2/31 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Investigations Gamma-glutamyltransferase increased	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	10.3% 3/29 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	12.9% 4/31 • Number of events 10 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Investigations Lipase increased	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	10.3% 3/29 • Number of events 7 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Investigations Weight decreased	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	29.4% 5/17 • Number of events 7 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.4% 1/29 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	6.5% 2/31 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	10.3% 3/29 • Number of events 5 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	12.9% 4/31 • Number of events 4 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	10.3% 3/29 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Musculoskeletal and connective tissue disorders Osteoporosis	16.7% 1/6 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	11.8% 2/17 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.4% 1/29 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Nervous system disorders Dizziness	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	10.3% 3/29 • Number of events 5 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Nervous system disorders Dysgeusia	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	17.6% 3/17 • Number of events 4 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	20.7% 6/29 • Number of events 13 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Nervous system disorders Headache	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	11.8% 2/17 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	10.3% 3/29 • Number of events 4 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Psychiatric disorders Insomnia	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.4% 1/29 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	3.2% 1/31 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Renal and urinary disorders Proteinuria	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/17 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	10.3% 3/29 • Number of events 4 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	9.7% 3/31 • Number of events 4 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	10.3% 3/29 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	12.9% 4/31 • Number of events 4 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	5.9% 1/17 • Number of events 1 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	13.8% 4/29 • Number of events 4 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	0.00% 0/31 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	33.3% 2/6 • Number of events 2 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	17.6% 3/17 • Number of events 3 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	13.8% 4/29 • Number of events 4 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)	9.7% 3/31 • Number of events 5 • Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)

Additional Information

Eisai Medical Information

Eisai Inc.

Phone: 1-888-274-2378

Email: [email protected]

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Principal investigator is a sponsor employee
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