Trial Outcomes & Findings for Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies (NCT NCT02807844)

NCT ID: NCT02807844

Last Updated: 2021-08-11

Results Overview

Phase Ib: To characterize the safety and tolerability of MCS110 in combination with PDR001 in patients with advanced solid malignancies and to identify a recommended dose combination for Phase II.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 141 participants
• Primary outcome timeframe: From start of treatment to a maximum timeframe of 116.4 weeks for phase Ib
• Results posted on: 2021-08-11

Participant Flow

Participant milestones

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Overall Study STARTED	6	12	12	13	6	11	20	20	21	20
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	6	12	12	13	6	11	20	20	21	20

Reasons for withdrawal

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Overall Study Physician Decision	0	0	0	0	0	0	3	0	1	2
Overall Study Death	0	0	2	4	1	2	1	2	0	1
Overall Study Withdrawal by Subject	0	0	2	1	1	0	1	0	0	0
Overall Study Progressive disease	5	12	8	8	3	8	14	17	19	15
Overall Study Adverse Event	1	0	0	0	1	1	1	1	1	2

Baseline Characteristics

Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies

Baseline characteristics by cohort

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=21 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)	Total n=141 Participants Total of all reporting groups
Age, Categorical <=18 years	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	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants	5 Participants n=21 Participants	8 Participants n=10 Participants	20 Participants n=115 Participants	11 Participants n=6 Participants	9 Participants n=6 Participants	12 Participants n=64 Participants	95 Participants n=17 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	0 Participants n=115 Participants	9 Participants n=6 Participants	12 Participants n=6 Participants	8 Participants n=64 Participants	46 Participants n=17 Participants
Age, Continuous	64.3 years STANDARD_DEVIATION 14.72 • n=5 Participants	56.9 years STANDARD_DEVIATION 11.13 • n=7 Participants	59.3 years STANDARD_DEVIATION 9.94 • n=5 Participants	55.4 years STANDARD_DEVIATION 10.03 • n=4 Participants	57.3 years STANDARD_DEVIATION 14.02 • n=21 Participants	58.6 years STANDARD_DEVIATION 11.13 • n=10 Participants	50.0 years STANDARD_DEVIATION 8.29 • n=115 Participants	61.5 years STANDARD_DEVIATION 11.33 • n=6 Participants	62.8 years STANDARD_DEVIATION 10.13 • n=6 Participants	60.7 years STANDARD_DEVIATION 13.15 • n=64 Participants	58.5 years STANDARD_DEVIATION 11.50 • n=17 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=10 Participants	20 Participants n=115 Participants	8 Participants n=6 Participants	21 Participants n=6 Participants	9 Participants n=64 Participants	96 Participants n=17 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=10 Participants	0 Participants n=115 Participants	12 Participants n=6 Participants	0 Participants n=6 Participants	11 Participants n=64 Participants	45 Participants n=17 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	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants
Race (NIH/OMB) Asian	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	2 Participants n=10 Participants	5 Participants n=115 Participants	4 Participants n=6 Participants	4 Participants n=6 Participants	7 Participants n=64 Participants	26 Participants n=17 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	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	1 Participants n=17 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	5 Participants n=21 Participants	9 Participants n=10 Participants	14 Participants n=115 Participants	14 Participants n=6 Participants	14 Participants n=6 Participants	12 Participants n=64 Participants	106 Participants n=17 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	0 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=64 Participants	1 Participants n=17 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants	1 Participants n=64 Participants	7 Participants n=17 Participants

PRIMARY outcome

Timeframe: From start of treatment to a maximum timeframe of 116.4 weeks for phase Ib

Population: Safety Analysis Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.

Phase Ib: To characterize the safety and tolerability of MCS110 in combination with PDR001 in patients with advanced solid malignancies and to identify a recommended dose combination for Phase II.

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety Adverse events (AEs) - all grades	6 Participants	12 Participants	12 Participants	13 Participants	6 Participants	11 Participants	—	—	—	—
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety Adverse events - Treatment-related - all grades	6 Participants	12 Participants	11 Participants	8 Participants	6 Participants	8 Participants	—	—	—	—
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety Serious Adverse Events (SAEs) - all grades	3 Participants	4 Participants	4 Participants	7 Participants	2 Participants	5 Participants	—	—	—	—
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety SAEs - Treatment-related - all grades	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety Fatal SAEs - all grades	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	—	—	—	—
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety Fatal SAEs - Treatment-related - all grades	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety AEs leading to discontinuation - all grades	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety AEs leading to discontinuation - Treatment-related - all grades	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety AEs leading to dose adjustment / interruption - all grades	4 Participants	4 Participants	4 Participants	2 Participants	2 Participants	6 Participants	—	—	—	—
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety AEs requiring additional therapy - all grades	6 Participants	12 Participants	10 Participants	12 Participants	4 Participants	10 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 4 years

Population: Full Analysis Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.

Overall Response Rate (ORR) is defined as the proportion of patients with a best overall response assessed by CT scan or MRI of complete response (CR), disappearance of all measurable and non-measurable lesions or partial response (PR), at least a 30% decrease in the sum of diameter of all measurable lesions, taking as reference the baseline sum of diameters,. based on local Investigator assessment, as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=21 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=20 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase II : Overall Response Rate (ORR) - Per RECIST v1.1	5 Percentage of participants Interval 0.3 to 21.6	0 Percentage of participants Interval 0.0 to 13.9	9.5 Percentage of participants Interval 1.7 to 27.1	0 Percentage of participants Interval 0.0 to 13.9	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 4 years

Population: Full Analysis Set. Since objective responses are rare in advanced pancreatic cancer and that long lasting stable disease is considered beneficial to patients, clinical benefit rate (confirmed objective response or SD\>4 months) was used as the primary endpoint for antitumor activity in this study changed from objective response to for this patient population.

Overall Response Rate (ORR) is defined as the proportion of patients with a best overall response assessed by CT scan or MRI of complete response (CR), disappearance of all measurable and non-measurable lesions or partial response (PR), at least a 30% decrease in the sum of diameter of all measurable lesions, taking as reference the baseline sum of diameters,. based on local Investigator assessment, as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) - mean (FAS)

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=21 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=20 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per RECIST v1.1 - Mean	6.7 Percentage of participants Interval 0.8 to 17.1	NA Percentage of participants Bayesian inference of Clinical Benefit Rate was measured for this arm instead - see Bayesian inference of Clinical Benefit Rate - per RECIST v1.1- mean results	10.8 Percentage of participants Interval 2.6 to 23.1	0.8 Percentage of participants Interval 0.0 to 4.5	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 4 years

Population: Full Analysis Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.

Phase II: Clinical Benefit Rate (Complete response (CR) or Partial response (PR) or Stable disease (SD) > 4 month)) per investigator based on Response evaluation criteria in solid tumors (RECIST) v1.1

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=21 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=20 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per RECIST v1.1	20 Percentage of participants Interval 7.1 to 40.1	0 Percentage of participants Interval 0.0 to 13.9	9.5 Percentage of participants Interval 1.7 to 27.1	10.0 Percentage of participants Interval 1.8 to 28.3	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 4 years

Population: Full Analysis Set. Since objective responses are rare in advanced pancreatic cancer and that long lasting stable disease is considered beneficial to patients, clinical benefit rate (confirmed objective response or SD\>4 months) was used as the primary endpoint for antitumor activity in this study changed from objective response to for this patient population.

Phase II: Clinical Benefit Rate (Complete response (CR) or Partial response (PR) or Stable disease (SD) > 4 month)) per investigator based on Response evaluation criteria in solid tumors (RECIST) v1.1

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=21 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=20 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase II: Bayesian Inference of Clinical Benefit Rate - Per RECIST v1.1- Mean	NA Percentage of participants Bayesian inference of Overall Response Rate was measured for this arm instead. See the Bayesian inference of Overall Response rate - per RECIST v1.1 - mean results	0.8 Percentage of participants Interval 0.0 to 4.5	NA Percentage of participants Bayesian inference of Overall Response Rate was measured for this arm instead. See the Bayesian inference of Overall Response rate - per RECIST v1.1 - mean results	NA Percentage of participants Bayesian inference of Overall Response Rate was measured for this arm instead. See the Bayesian inference of Overall Response rate - per RECIST v1.1 - mean results	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Measured up to a max of 112.4 weeks

Population: Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.

To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II. Planned dose intensity for MCS110 is cumulative planned dose (mg/kg)/ number of doses scheduled per protocol during treatment period (i.e., this is equivalent to planned dose level).

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib: Planned Dose Intensity - MCS110	0.86 mg/kg/3wks Standard Deviation 0.191	2.74 mg/kg/3wks Standard Deviation 0.386	2.66 mg/kg/3wks Standard Deviation 0.435	4.85 mg/kg/3wks Standard Deviation 0.286	7.05 mg/kg/3wks Standard Deviation 0.594	9.47 mg/kg/3wks Standard Deviation 1.093	—	—	—	—

PRIMARY outcome

Timeframe: Measured up to a max of 112.4 weeks

Population: Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.

To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II. Relative dose intensity (%) is 100 × dose intensity (mg/kg/3wks)/planned dose intensity (mg/kg/3wks).

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib: Relative Dose Intensity - MCS110	100 Percentage Standard Deviation 100	100 Percentage Standard Deviation 100	100 Percentage Standard Deviation 100	99.23 Percentage Standard Deviation 2.774	100 Percentage Standard Deviation 100	100 Percentage Standard Deviation 100	—	—	—	—

PRIMARY outcome

Timeframe: Measured up to a max of 112.4 weeks

Population: Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.

To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II. Planned dose intensity for PDR001 (mg/3wks) is planned cumulative dose (mg)/ number of doses scheduled per protocol during treatment period (i.e., this is equivalent to planned dose level).

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib: Planned Dose Intensity - PDR001	86.09 mg/3wks Standard Deviation 19.058	91.18 mg/3wks Standard Deviation 12.873	265.83 mg/3wks Standard Deviation 43.528	293.59 mg/3wks Standard Deviation 16.013	282.12 mg/3wks Standard Deviation 23.773	289.04 mg/3wks Standard Deviation 20.329	—	—	—	—

PRIMARY outcome

Timeframe: Measured up to a max of 112.4 weeks

Population: Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.

To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II. Relative dose intensity (%) is 100 × dose intensity (mg/3wks)/planned dose intensity (mg/3wks).

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib: Relative Dose Intensity - PDR001	100.00 Percentage Standard Deviation 100.00	100.00 Percentage Standard Deviation 100.00	100.00 Percentage Standard Deviation 100.00	100.00 Percentage Standard Deviation 100.00	100.00 Percentage Standard Deviation 100.00	100.00 Percentage Standard Deviation 100.00	—	—	—	—

PRIMARY outcome

Timeframe: Measured up to a max of 112.4 weeks

Population: Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.

To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II.

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib: Number of Participants With Dose Reductions n (%) of participants with no dose reduction- Study drug: MCS110	6 Participants	12 Participants	12 Participants	13 Participants	6 Participants	9 Participants	—	—	—	—
Phase Ib: Number of Participants With Dose Reductions n (%) of participants with no dose reduction- Study drug: PDR001	6 Participants	12 Participants	12 Participants	13 Participants	6 Participants	11 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Measured up to a max of 112.4 weeks

Population: Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.

To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II.

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib: Number of Dose Interruptions Per Participant Number of dose interruptions per subject - Study drug: MCS110	1.3 Dose interruptions per participant Standard Deviation 1.97	0.3 Dose interruptions per participant Standard Deviation 0.45	0.3 Dose interruptions per participant Standard Deviation 0.45	0.0 Dose interruptions per participant Standard Deviation 0.0	0.3 Dose interruptions per participant Standard Deviation 0.52	0.1 Dose interruptions per participant Standard Deviation 0.30	—	—	—	—
Phase Ib: Number of Dose Interruptions Per Participant Number of dose interruptions per subject - Study drug: PDR001	1.3 Dose interruptions per participant Standard Deviation 1.97	0.3 Dose interruptions per participant Standard Deviation 0.45	0.3 Dose interruptions per participant Standard Deviation 0.45	0.0 Dose interruptions per participant Standard Deviation 0.0	0.3 Dose interruptions per participant Standard Deviation 0.52	0.1 Dose interruptions per participant Standard Deviation 0.30	—	—	—	—

PRIMARY outcome

Timeframe: Measured up to a max of 112.4 weeks

Population: Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.

To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II.

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib: Number of Subjects With at Least One Dose Interruption Number of subjects with at least one dose interruption - by reason - Adverse Event - MCS110	3 Participants	3 Participants	3 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—
Phase Ib: Number of Subjects With at Least One Dose Interruption Number of subjects with at least one dose interruption - by reason - Adverse Event - PDR001	3 Participants	3 Participants	3 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: the first 2 cycles of study treatment; cycle = 21 days (i.e., at day 42)

Population: Dose Determination Set (DDS). A statistical analysis for this endpoint was not performed since it is not clinically relevant.

Phase Ib: Dose limiting toxicities occurring during the first 2 cycles by system organ class, preferred term and maximum grade for Phase Ib. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 was used for all grading.

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=5 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=11 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=9 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=7 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=4 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=4 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment n (%) of subjects with at least one event - all grades	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—
Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment n (%) Investigations - all grades	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—
Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment n (%) Blood creatine phosphokinase increased - all grades	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set

Phase II: Overall Response Rate (Complete response (CR) or Partial response (PR)) (with confirmation) as per investigator based on immune related Response criteria (irRC) (FAS)

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=21 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=20 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase II : Overall Response Rate (ORR) - Per irRC	5 Percentage of participants Interval 0.3 to 21.6	0 Percentage of participants Interval 0.0 to 13.9	9.5 Percentage of participants Interval 1.7 to 27.1	0 Percentage of participants Interval 0.0 to 13.9	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set

Phase Ib: Overall Response Rate (Complete response (CR) or Partial response (PR)), per RECIST v1.1 and per immune related Response criteria (irRC)

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib: Overall Response Rate (ORR) Overall Response Rate as per investigator based on RECIST v1.1	16.7 Percentage of participants Interval 0.9 to 58.2	0 Percentage of participants Interval 0.0 to 22.1	0 Percentage of participants Interval 0.0 to 22.1	0 Percentage of participants Interval 0.0 to 20.6	0 Percentage of participants Interval 0.0 to 39.3	9.1 Percentage of participants Interval 0.5 to 36.4	—	—	—	—
Phase Ib: Overall Response Rate (ORR) Overall Response Rate - as per investigator based on irRC	16.7 Percentage of participants Interval 0.9 to 58.2	0 Percentage of participants Interval 0.0 to 22.1	0 Percentage of participants Interval 0.0 to 22.1	0 Percentage of participants Interval 0.0 to 20.6	0 Percentage of participants Interval 0.0 to 39.3	9.1 Percentage of participants Interval 0.5 to 36.4	—	—	—	—

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set. Since objective responses are rare in advanced pancreatic cancer and that long lasting stable disease is considered beneficial to patients, clinical benefit rate (confirmed objective response or SD\>4 months) was used as the primary endpoint for antitumor activity in this study changed from objective response to for this patient population.

Phase II: Overall Response Rate (Complete response (CR) or Partial response (PR)) (with confirmation) as per investigator based on immune related Response criteria (irRC)- mean (FAS)

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=21 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=20 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per irRC - Mean	6.7 Percentage of participants Interval 0.8 to 17.1	NA Percentage of participants Bayesian inference of Clinical Benefit Rate was measured for this arm instead - see Bayesian inference of Clinical Benefit Rate - per irRC - mean results	10.8 Percentage of participants Interval 2.6 to 23.1	0.8 Percentage of participants Interval 0.0 to 4.5	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set

Phase 1b: Clinical Benefit Rate (Complete response (CR) or Partial response (PR) or Stable disease (SD) > 4 month)) per RECIST v1.1 and per immune related Response criteria (irRC)

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase 1b: Clinical Benefit Rate (CBR) Clinical Benefit Rate - as per investigator based on RECIST v1.1	33.3 Percentage of participants Interval 6.3 to 72.9	8.3 Percentage of participants Interval 0.4 to 33.9	0 Percentage of participants Interval 0.0 to 22.1	0 Percentage of participants Interval 0.0 to 20.6	0 Percentage of participants Interval 0.0 to 39.3	18.2 Percentage of participants Interval 3.3 to 47.0	—	—	—	—
Phase 1b: Clinical Benefit Rate (CBR) Clinical Benefit Rate - as per investigator based on irRC	50.0 Percentage of participants Interval 15.3 to 84.7	8.3 Percentage of participants Interval 0.4 to 33.9	0 Percentage of participants Interval 0.0 to 22.1	7.7 Percentage of participants Interval 0.4 to 31.6	33.3 Percentage of participants Interval 6.3 to 72.9	18.2 Percentage of participants Interval 3.3 to 47.0	—	—	—	—

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set

Phase II: Clinical Benefit Rate (Complete response (CR) or Partial response (PR) or Stable disease (SD) > 4 month)) per immune related Response criteria (irRC)

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=21 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=20 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per irRC	20.0 Percentage of participants Interval 7.1 to 40.1	5.0 Percentage of participants Interval 0.3 to 21.6	19.0 Percentage of participants Interval 6.8 to 38.4	30.0 Percentage of participants Interval 14.0 to 50.8	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set. Since objective responses are rare in advanced pancreatic cancer and that long lasting stable disease is considered beneficial to patients, clinical benefit rate (confirmed objective response or SD\>4 months) was used as the primary endpoint for antitumor activity in this study changed from objective response to for this patient population.

Phase II: Clinical Benefit Rate (Complete response (CR) or Partial response (PR) or Stable disease (SD) > 4 month)) per investigator based on immune related Response criteria (irRC)- mean (FAS)

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=21 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=20 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase II: Bayesian Inference of Clinical Benefit Rate - Per irRC - Mean	NA Percentage of participants Bayesian inference of Overall Response Rate was measured for this arm instead. See the Bayesian inference of Overall Response rate - per irRC - mean results	5.6 Percentage of participants Interval 0.4 to 15.3	NA Percentage of participants Bayesian inference of Overall Response Rate was measured for this arm instead. See the Bayesian inference of Overall Response rate - per irRC - mean results	NA Percentage of participants Bayesian inference of Overall Response Rate was measured for this arm instead. See the Bayesian inference of Overall Response rate - per irRC - mean results	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to year 4

Population: Full Analysis Set

Phase 1b and Phase II: Progression Free Survival. Progression is defined as a 20% increase in the sum of diameter of measurable lesions taking as reference the smallest sum of diameter recorded at or after baseline, or worsening of non-measurable lesions or the appearance of new lesions, using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or Per Immune Related Response Criteria (irRC). Unlike RECIST 1.1, PD per irRC requires confirmation at a new assessment after at least 4 weeks - using Kaplan-Meier method - Median.

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=21 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase 1b and Phase II: Progression Free Survival Based on Investigator Assessment as Per RECIST v1.1 and Per Immune Related Response Criteria (irRC) - Using Kaplan-Meier Method - Median Median PFS - per RECIST v1.1	1.5 months Interval 1.1 to 14.8	1.3 months Interval 1.3 to 2.7	1.3 months Interval 0.8 to 1.3	1.1 months Interval 0.6 to 1.3	1.3 months Interval 0.5 to 4.0	1.2 months Interval 0.6 to 2.4	1.6 months Interval 1.4 to 2.8	1.3 months Interval 1.2 to 1.4	1.3 months Interval 1.2 to 1.4	2.4 months Interval 1.4 to 3.7
Phase 1b and Phase II: Progression Free Survival Based on Investigator Assessment as Per RECIST v1.1 and Per Immune Related Response Criteria (irRC) - Using Kaplan-Meier Method - Median Median PFS - per iiRC	8.2 months Interval 1.2 to 25.8	2.2 months Interval 1.3 to 2.7	1.3 months Interval 0.9 to 1.3	1.0 months Interval 0.5 to 1.3	1.3 months Interval 0.5 to 16.8	1.2 months Interval 0.7 to 2.4	1.6 months Interval 1.4 to 2.8	1.3 months Interval 1.2 to 1.5	1.3 months Interval 1.2 to 1.4	3.7 months Interval 1.4 to 4.2

SECONDARY outcome

Timeframe: Up to year 4

Population: Full Analysis Set

Phase 1b and Phase II: Overall Survival - using Kaplan-Meier method - Median

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=21 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median	12.3 months Interval 3.1 to 26.6	9.6 months Interval 3.8 to 12.2	4.2 months Interval 1.5 to 7.9	2.8 months Interval 1.2 to 3.8	22.8 months Interval 1.1 to 26.8	5.7 months Interval 1.2 to 8.2	8.9 months Interval 5.6 to 16.6	2.6 months Interval 1.8 to 5.0	11.7 months Interval 9.2 to 14.6	19.7 months Interval 9.2 to 20.3

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set

Phase 1b and Phase II: Duration of Response (DOR) per RECIST v1.1 and per immune related Response criteria (irRC)

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=21 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase 1b and Phase II: Duration of Response (DOR) Duration of response(days) - based on RECIST v1.1	372.0 days Interval 372.0 to 372.0	NA days The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.	NA days The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.	NA days The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.	NA days The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.	155.0 days Interval 155.0 to 155.0	169 days Interval 169.0 to 169.0	NA days The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.	328.5 days Interval 194.0 to 463.0	NA days The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.
Phase 1b and Phase II: Duration of Response (DOR) Duration of response(days) - based on irRC	372.0 days Interval 372.0 to 372.0	NA days The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.	NA days The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.	NA days The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.	NA days The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.	155.0 days Interval 155.0 to 155.0	169 days Interval 169.0 to 169.0	NA days The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.	328.5 days Interval 194.0 to 463.0	NA days The median is not available because there was an insufficient number of participants with events. The lower and upper limits are not applicable since there is no value for median.

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set

Phase 1b and Phase II: Disease Control Rate (Complete response (CR) or Partial response (PR) or Stable disease (SD) > 4 month)) per RECIST v1.1 and per immune related Response criteria (irRC)

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=21 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase 1b and Phase II: Disease Control Rate (DCR) Disease Control Rate - as per investigator based on RECIST v1.1	33.3 Percentage Interval 6.3 to 72.9	8.3 Percentage Interval 0.4 to 33.9	0 Percentage Interval 0.0 to 22.1	15.4 Percentage Interval 2.8 to 41.0	16.7 Percentage Interval 0.9 to 58.2	18.2 Percentage Interval 3.3 to 47.0	20.0 Percentage Interval 7.1 to 40.1	0 Percentage Interval 0.0 to 13.9	19.0 Percentage Interval 6.8 to 38.4	35.0 Percentage Interval 17.7 to 55.8
Phase 1b and Phase II: Disease Control Rate (DCR) Disease Control Rate as per investigator based on irRC	50.0 Percentage Interval 15.3 to 84.7	8.3 Percentage Interval 0.4 to 33.9	0 Percentage Interval 0.0 to 22.1	15.4 Percentage Interval 2.8 to 41.0	33.3 Percentage Interval 6.3 to 72.9	18.2 Percentage Interval 3.3 to 47.0	20.0 Percentage Interval 7.1 to 40.1	5.0 Percentage Interval 0.3 to 21.6	19.0 Percentage Interval 6.8 to 38.4	45.0 Percentage Interval 25.9 to 65.3

SECONDARY outcome

Timeframe: From start of treatment to a maximum timeframe of 92.4 weeks for phase II.

Population: Safety Analysis Set

Phase II: To further characterize the safety and tolerability of MCS110 given in combination with PDR001

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=20 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=21 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=20 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety Adverse events - all grades	20 Participants	20 Participants	21 Participants	20 Participants	—	—	—	—	—	—
Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety Adverse events - Treatment-related - all grades	16 Participants	15 Participants	17 Participants	19 Participants	—	—	—	—	—	—
Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety SAEs - all grades	8 Participants	14 Participants	8 Participants	7 Participants	—	—	—	—	—	—
Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety SAEs - Treatment-related - all grades	1 Participants	4 Participants	4 Participants	1 Participants	—	—	—	—	—	—
Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety Fatal SAEs - all grades	1 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety Fatal SAEs - Treatment-related - all grades	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety AEs leading to discontinuation - all grades	1 Participants	1 Participants	1 Participants	2 Participants	—	—	—	—	—	—
Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety AEs leading to discontinuation - Treatment-related - all grades	1 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—
Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety AEs leading to dose adjustment / interruption - all grades	11 Participants	4 Participants	8 Participants	11 Participants	—	—	—	—	—	—
Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety AEs requiring additional therapy - all grades	19 Participants	18 Participants	19 Participants	17 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set

Phase Ib and Phase II: Presence of anti-MCS110 antibodies

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=21 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Immunogenicity MCS110 Baseline positive	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity MCS110 Baseline negative	6 Participants	11 Participants	11 Participants	12 Participants	6 Participants	11 Participants	19 Participants	19 Participants	17 Participants	18 Participants
Phase Ib and Phase II: Immunogenicity MCS110 Baseline missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	4 Participants	2 Participants
Phase Ib and Phase II: Immunogenicity MCS110 Baseline positive, on treatment persistent positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity MCS110 Baseline positive, on treatment only last positive	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity MCS110 Baseline positive, on treatment any positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity MCS110 Baseline positive, on treatment all negative	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity MCS110 Baseline negative, on treatment persistent positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity MCS110 Baseline negative, on treatment only last positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity MCS110 Baseline negative, on treatment any positive	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity MCS110 Baseline negative, on treatment all negative	5 Participants	10 Participants	8 Participants	6 Participants	5 Participants	6 Participants	12 Participants	16 Participants	14 Participants	17 Participants
Phase Ib and Phase II: Immunogenicity MCS110 Baseline missing, on treatment persistent positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity MCS110 Baseline missing, on treatment only last positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity MCS110 Baseline missing, on treatment any positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity MCS110 Baseline missing, on treatment all negative	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set

Phase Ib and Phase II: Presence of anti-PDR001 antibodies

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=21 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Immunogenicity PDR001 Baseline missing, on treatment any positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity PDR001 Baseline positive	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Phase Ib and Phase II: Immunogenicity PDR001 Baseline negative	6 Participants	10 Participants	11 Participants	10 Participants	5 Participants	8 Participants	18 Participants	17 Participants	19 Participants	19 Participants
Phase Ib and Phase II: Immunogenicity PDR001 Baseline missing	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	2 Participants	2 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity PDR001 Baseline positive, on treatment persistent positive	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity PDR001 Baseline positive, on treatment only last positive	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity PDR001 Baseline positive, on treatment any positive	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Phase Ib and Phase II: Immunogenicity PDR001 Baseline positive, on treatment all negative	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity PDR001 Baseline negative, on treatment persistent positive	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Phase Ib and Phase II: Immunogenicity PDR001 Baseline negative, on treatment only last positive	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	4 Participants	1 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity PDR001 Baseline negative, on treatment any positive	1 Participants	3 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Phase Ib and Phase II: Immunogenicity PDR001 Baseline negative, on treatment all negative	4 Participants	4 Participants	8 Participants	6 Participants	4 Participants	2 Participants	11 Participants	10 Participants	16 Participants	13 Participants
Phase Ib and Phase II: Immunogenicity PDR001 Baseline missing, on treatment persistent positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity PDR001 Baseline missing, on treatment only last positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Immunogenicity PDR001 Baseline missing, on treatment all negative	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: cycle 1 (day 21) and cycle 4 (day 84)

Population: Pharmacokinetic analysis set. Some patients were excluded because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples. There were some patients with AUClast but no AUCinf parameters because AUCinf could not be extrapolated from the data (i.e. the % of AUC extrapolated past the last time point is greater than 20% or the adjusted R squared parameter for the regression fit of the terminal phase of the PK profile is \< 0.75).

Phase Ib and Phase II: PK Parameters - AUClast, which is the AUC from time zero to the last measurable concentration sampling time (tlast) (mass × time

× volume-1); and AUCinf, which is the AUC from time zero to infinity (mass × time × volume-1) - MCS110

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=11 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=19 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf AUClast (day*ng/mL) - cycle 1 - day 21	46900 day*ng/mL Standard Deviation 9080	343000 day*ng/mL Standard Deviation 142000	249000 day*ng/mL Standard Deviation 93400	490000 day*ng/mL Standard Deviation 149000	909000 day*ng/mL Standard Deviation 233000	1090000 day*ng/mL Standard Deviation 231000	1200000 day*ng/mL Standard Deviation 507000	1090000 day*ng/mL Standard Deviation 352000	1120000 day*ng/mL Standard Deviation 440000	1270000 day*ng/mL Standard Deviation 335000
Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf AUCinf (day*ng/mL) - cycle 1 - day 21	50100 day*ng/mL Standard Deviation 11600	383000 day*ng/mL Standard Deviation 178000	330000 day*ng/mL Standard Deviation 73400	560000 day*ng/mL Standard Deviation 177000	1020000 day*ng/mL Standard Deviation 336000	988000 day*ng/mL Standard Deviation 116000	—	—	—	—
Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf AUClast (day*ng/mL) - cycle 4 - day 84	41000 day*ng/mL Standard Deviation 22800	213000 day*ng/mL Standard Deviation 92200	232000 day*ng/mL Standard Deviation 99300	710000 day*ng/mL Standard Deviation 171000	1520000 day*ng/mL Standard Deviation 353000	1200000 day*ng/mL Standard Deviation 1030000	1200000 day*ng/mL Standard Deviation 389000	918000 day*ng/mL Standard Deviation 102000	1010000 day*ng/mL Standard Deviation 337000	1240000 day*ng/mL Standard Deviation 499000
Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf AUCinf (day*ng/mL) - cycle 4 - day 84	42300 day*ng/mL Standard Deviation 21900	260000 day*ng/mL Standard Deviation 73500	253000 day*ng/mL Standard Deviation 114000	619000 day*ng/mL Standard Deviation NA SD is not applicable for an analysis with 1 participant	—	769000 day*ng/mL Standard Deviation NA SD is not applicable for an analysis with 1 participant	—	—	—	—

SECONDARY outcome

Timeframe: cycle 1 (day 21) and cycle 4 (day 84)

Population: Pharmacokinetic analysis set. Some patients were excluded because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples. There were some patients with AUClast but no AUCinf parameters because AUCinf could not be extrapolated from the data (i.e. the % of AUC extrapolated past the last time point is greater than 20% or the adjusted R squared parameter for the regression fit of the terminal phase of the PK profile is \< 0.75).

Phase Ib and Phase II: Pharmacokinetics (PK) Parameters - AUClast, which is the AUC from time zero to the last measurable concentration sampling time (tlast) (mass × time

× volume-1); and AUCinf, which is the AUC from time zero to infinity (mass × time × volume-1) and AUCinf - PDR001

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=11 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=19 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf AUClast (day*ug/mL) - cycle 1 - day 21	229 day*ug/mL Standard Deviation 68.3	271 day*ug/mL Standard Deviation 53.8	651 day*ug/mL Standard Deviation 322	604 day*ug/mL Standard Deviation 309	581 day*ug/mL Standard Deviation 147	450 day*ug/mL Standard Deviation 135	825 day*ug/mL Standard Deviation 402	782 day*ug/mL Standard Deviation 264	764 day*ug/mL Standard Deviation 311	782 day*ug/mL Standard Deviation 307
Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf AUCinf (day*ug/mL) - cycle 1 - day 21	—	274 day*ug/mL Standard Deviation NA SD is not applicable for an analysis with 1 participant	610 day*ug/mL Standard Deviation NA SD is not applicable for an analysis with 1 participant	—	747 day*ug/mL Standard Deviation NA SD is not applicable for an analysis with 1 participant	710 day*ug/mL Standard Deviation NA SD is not applicable for an analysis with 1 participant	—	—	—	—
Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf AUClast (day*ug/mL) - cycle 4 - day 84	369 day*ug/mL Standard Deviation 26.4	330 day*ug/mL Standard Deviation 182	1020 day*ug/mL Standard Deviation 526	2020 day*ug/mL Standard Deviation 1170	954 day*ug/mL Standard Deviation 179	718 day*ug/mL Standard Deviation 288	1170 day*ug/mL Standard Deviation 388	1330 day*ug/mL Standard Deviation 555	1660 day*ug/mL Standard Deviation 283	1260 day*ug/mL Standard Deviation 533
Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf AUCinf (day*ug/mL) - cycle 4 - day 84	—	196 day*ug/mL Standard Deviation NA SD is not applicable for an analysis with 1 participant	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: cycle 1 (day 21) and cycle 4 (day 84)

Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.

Phase Ib and Phase II: PK Parameters - Cmax, which is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass × volume-1); and Clast - MCS110

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=11 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=19 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast Cmax (ng/mL) - cycle 1 - day 21	17400 ng/mL Standard Deviation 1870	58800 ng/mL Standard Deviation 16900	56700 ng/mL Standard Deviation 17800	96900 ng/mL Standard Deviation 28600	122000 ng/mL Standard Deviation 17100	186000 ng/mL Standard Deviation 54000	158000 ng/mL Standard Deviation 44800	130000 ng/mL Standard Deviation 38400	134000 ng/mL Standard Deviation 64900	151000 ng/mL Standard Deviation 42500
Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast Clast (ng/mL) - cycle 1 - day 21	1120 ng/mL Standard Deviation 795	1290 ng/mL Standard Deviation 2760	6600 ng/mL Standard Deviation 6370	9130 ng/mL Standard Deviation 11500	15100 ng/mL Standard Deviation 9070	28700 ng/mL Standard Deviation 27800	33000 ng/mL Standard Deviation 21300	12900 ng/mL Standard Deviation 10700	24500 ng/mL Standard Deviation 20100	17500 ng/mL Standard Deviation 11400
Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast Cmax (ng/mL) -- cycle 4 - day 84	13500 ng/mL Standard Deviation 5580	53000 ng/mL Standard Deviation 9790	48900 ng/mL Standard Deviation 14100	76400 ng/mL Standard Deviation 24000	176000 ng/mL Standard Deviation 19800	189000 ng/mL Standard Deviation 29400	159000 ng/mL Standard Deviation 39800	152000 ng/mL Standard Deviation 58000	128000 ng/mL Standard Deviation 42600	147000 ng/mL Standard Deviation 38300
Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast Clast (ng/mL) - cycle 4 - day 84	510 ng/mL Standard Deviation 457	5700 ng/mL Standard Deviation 10300	3490 ng/mL Standard Deviation 2410	7350 ng/mL Standard Deviation 5870	45100 ng/mL Standard Deviation 12400	34100 ng/mL Standard Deviation 29800	57600 ng/mL Standard Deviation 45000	33300 ng/mL Standard Deviation 42600	18600 ng/mL Standard Deviation 21700	29400 ng/mL Standard Deviation 20700

SECONDARY outcome

Timeframe: cycle 1 (day 21) and cycle 4 (day 84)

Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.

Phase Ib and Phase II: PK Parameters - Cmax, which is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass × volume-1); and Clast - PDR001

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=11 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=19 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast Cmax (ug/mL) - cycle 1 - day 21	24 ug/mL Standard Deviation 9.52	29.5 ug/mL Standard Deviation 6.56	73.4 ug/mL Standard Deviation 22.3	77 ug/mL Standard Deviation 24.3	76.6 ug/mL Standard Deviation 36.8	64.2 ug/mL Standard Deviation 20.4	94.5 ug/mL Standard Deviation 27.4	75.3 ug/mL Standard Deviation 23.9	80.2 ug/mL Standard Deviation 24	70.3 ug/mL Standard Deviation 21.6
Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast Clast (ug/mL) - cycle 1 - day 21	7.73 ug/mL Standard Deviation 2.97	7.24 ug/mL Standard Deviation 2.95	19.4 ug/mL Standard Deviation 11.7	26.4 ug/mL Standard Deviation 11.8	22.7 ug/mL Standard Deviation 12.8	17.2 ug/mL Standard Deviation 8.67	34.5 ug/mL Standard Deviation 13.3	24 ug/mL Standard Deviation 12	22.8 ug/mL Standard Deviation 9.44	24.4 ug/mL Standard Deviation 14.6
Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast Cmax (ug/mL) -- cycle 4 - day 84	29.5 ug/mL Standard Deviation 9.3	36.8 ug/mL Standard Deviation 10.5	126 ug/mL Standard Deviation 54.6	153 ug/mL Standard Deviation 22.6	92 ug/mL Standard Deviation 22.1	85.9 ug/mL Standard Deviation 16.8	123 ug/mL Standard Deviation 56.8	127 ug/mL Standard Deviation 7	122 ug/mL Standard Deviation 23.6	108 ug/mL Standard Deviation 23.4
Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast Clast (ug/mL) - cycle 4 - day 84	10.7 ug/mL Standard Deviation 2.25	14.5 ug/mL Standard Deviation 8.47	65.1 ug/mL Standard Deviation 37.6	71 ug/mL Standard Deviation 6.65	47.5 ug/mL Standard Deviation 25.7	35.6 ug/mL Standard Deviation 14.7	81.4 ug/mL Standard Deviation 43.6	62.1 ug/mL Standard Deviation 9.93	48.8 ug/mL Standard Deviation 20.6	51.3 ug/mL Standard Deviation 23.7

SECONDARY outcome

Timeframe: cycle 1 (day 21) and cycle 4 (day 84)

Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.

Phase Ib and Phase II: PK Parameters - Tmax, which is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time) - MCS110

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=11 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=19 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax Tmax (h) - cycle 1 - day 21	2.02 hour Interval 1.5 to 2.08	1.92 hour Interval 0.5 to 23.7	2.08 hour Interval 1.5 to 22.2	2.13 hour Interval 1.92 to 24.0	2.06 hour Interval 2.0 to 24.4	2.04 hour Interval 1.92 to 26.2	2.01 hour Interval 0.5 to 162.0	2.08 hour Interval 1.92 to 2.28	2.09 hour Interval 2.0 to 163.0	2.08 hour Interval 1.5 to 188.0
Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax Tmax (h) - cycle 4 - day 84	2 hour Interval 2.0 to 2.0	2.05 hour Interval 0.5 to 2.08	2.03 hour Interval 2.0 to 23.7	13 hour Interval 2.02 to 24.0	2 hour Interval 2.0 to 20.8	2.03 hour Interval 1.98 to 21.3	2 hour Interval 1.92 to 2.12	2.02 hour Interval 1.98 to 2.08	2.04 hour Interval 2.0 to 2.12	2.05 hour Interval 2.0 to 2.13

SECONDARY outcome

Timeframe: cycle 1 (day 21) and cycle 4 (day 84)

Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.

Phase Ib and Phase II: PK Parameters - Tmax, which is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time) - PDR001

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=11 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=19 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax Tmax (h) - cycle 1 - day 21	11.5 hour Interval 1.48 to 26.0	2.08 hour Interval 1.5 to 25.5	1.53 hour Interval 1.0 to 26.5	1.57 hour Interval 1.5 to 22.3	1.53 hour Interval 0.983 to 25.8	1.52 hour Interval 1.5 to 22.8	1.5 hour Interval 1.0 to 168.0	1.5 hour Interval 0.5 to 3.22	1.5 hour Interval 1.42 to 166.0	1.5 hour Interval 1.45 to 624.0
Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax Tmax (h) - cycle 4 - day 84	1.52 hour Interval 1.5 to 22.4	1.53 hour Interval 0.0 to 23.7	1.2 hour Interval 0.0 to 1.5	1.57 hour Interval 1.55 to 1.58	1.5 hour Interval 1.5 to 3.42	1.45 hour Interval 1.43 to 2.92	1.53 hour Interval 1.5 to 165.0	1.47 hour Interval 1.42 to 1.48	1.54 hour Interval 1.48 to 1.62	1.5 hour Interval 1.43 to 1.67

SECONDARY outcome

Timeframe: cycle 1 (day 21) and cycle 4 (day 84)

Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.

Phase Ib and Phase II: PK Parameters - T1/2, which is the terminal half-life associated with the terminal slope of a semi logarithmic concentration time curve (time) - MCS110

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=11 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=19 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 T1/2 (day) - cycle 1 - day 21	1.5 day Interval 1.25 to 2.38	2.16 day Interval 1.68 to 6.71	3.3 day Interval 1.85 to 5.32	3.48 day Interval 1.73 to 7.82	6.35 day Interval 2.17 to 8.05	4.36 day Interval 2.25 to 6.62	—	—	—	—
Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 T1/2 (day) - cycle 4 - day 84	1.77 day Interval 1.23 to 1.81	1.53 day Interval 1.03 to 2.49	4.08 day Interval 1.41 to 4.26	6.32 day Interval 6.32 to 6.32	—	4.82 day Interval 4.82 to 4.82	—	—	—	—

SECONDARY outcome

Timeframe: cycle 1 (day 21) and cycle 4 (day 84)

Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.

Phase Ib and Phase II: PK Parameters - T1/2, which is the terminal half-life associated with the terminal slope of a semi logarithmic concentration time curve (time) - PDR001

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=11 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=19 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Pharmacokinetics of PDR001 - T1/2 T1/2 (day) - cycle 1 - day 21	—	8.14 day Interval 8.14 to 8.14	7.71 day Interval 7.71 to 7.71	—	7.13 day Interval 7.13 to 7.13	7.33 day Interval 7.33 to 7.33	—	—	—	—
Phase Ib and Phase II: Pharmacokinetics of PDR001 - T1/2 T1/2 (day) - cycle 4 - day 84	—	7.81 day Interval 7.81 to 7.81	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: cycle 1 (day 21) and cycle 4 (day 84)

Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.

Phase Ib and Phase II: PK Parameters - CL, which is the total body clearance of drug from the plasma (volume × time-1) - MCS110

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=11 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=19 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL CL (L/h/kg) - cycle 1 - day 21	0.000863 L/h/kg Standard Deviation 0.000158	0.000388 L/h/kg Standard Deviation 0.000181	0.000394 L/h/kg Standard Deviation 0.0000833	0.000407 L/h/kg Standard Deviation 0.000131	0.000338 L/h/kg Standard Deviation 0.000117	0.000427 L/h/kg Standard Deviation 0.0000558	—	—	—	—
Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL CL (L/h/kg) - cycle 4 - day 84	0.00117 L/h/kg Standard Deviation 0.000549	0.000523 L/h/kg Standard Deviation 0.000199	0.000315 L/h/kg Standard Deviation 0.000218	0.000337 L/h/kg Standard Deviation NA Not Evaluable	—	0.000541 L/h/kg Standard Deviation NA Not Evaluable	—	—	—	—

SECONDARY outcome

Timeframe: cycle 1 (day 21) and cycle 4 (day 84)

Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.

Phase Ib and Phase II: PK Parameters - CL, which is the total body clearance of drug from the plasma (volume × time-1) - PDR001

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=11 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=19 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Pharmacokinetics of PDR001 - CL CL (L/h) - cycle 1 - day 21	—	0.0152 L/h Standard Deviation NA Not Evaluable	0.0205 L/h Standard Deviation NA Not Evaluable	—	0.0167 L/h Standard Deviation NA Not Evaluable	0.0176 L/h Standard Deviation NA Not Evaluable	—	—	—	—
Phase Ib and Phase II: Pharmacokinetics of PDR001 - CL CL (L/h) - cycle 4 - day 84	—	0.0213 L/h Standard Deviation NA Not Evaluable	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: cycle 1 (day 21) and cycle 4 (day 84)

Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.

Phase Ib and Phase II: PK Parameters - Vz, which is the apparent volume of distribution during terminal phase (volume) - MCS110

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=11 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=19 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz Vz (L/kg) - cycle 1 - day 21	0.0486 L/kg Standard Deviation 0.00989	0.0334 L/kg Standard Deviation 0.00783	0.0423 L/kg Standard Deviation 0.00875	0.051 L/kg Standard Deviation 0.0206	0.0651 L/kg Standard Deviation 0.0201	0.065 L/kg Standard Deviation 0.0267	—	—	—	—
Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz Vz (L/kg) - cycle 4 - day 84	0.0684 L/kg Standard Deviation 0.0407	0.0294 L/kg Standard Deviation 0.0128	0.045 L/kg Standard Deviation 0.0308	0.0736 L/kg Standard Deviation NA Not Evaluable	—	0.0904 L/kg Standard Deviation NA Not Evaluable	—	—	—	—

SECONDARY outcome

Timeframe: cycle 1 (day 21) and cycle 4 (day 84)

Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.

Phase Ib and Phase II: PK Parameters - Vz, which is the apparent volume of distribution during terminal phase (volume) - PDR001

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=11 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=19 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Pharmacokinetics of PDR001 - Vz Vz (L) - cycle 1 - day 21	—	4.28 Liters (L) Standard Deviation NA Not Evaluable	5.47 Liters (L) Standard Deviation NA Not Evaluable	—	4.13 Liters (L) Standard Deviation NA Not Evaluable	4.47 Liters (L) Standard Deviation NA Not Evaluable	—	—	—	—
Phase Ib and Phase II: Pharmacokinetics of PDR001 - Vz Vz (L) - cycle 4 - day 84	—	5.76 Liters (L) Standard Deviation NA Not Evaluable	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: cycle 4 (day 84)

Population: Pharmacokinetic analysis set

Phase Ib and Phase II: PK Parameters - Accumulation ratio (AR), which is the AUClast (multiple Dose)/AUClast (single dose) (for cycle 4 only) - MCS110

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=3 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=4 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=2 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=3 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=3 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=4 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=3 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=4 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=12 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR)	0.789 Ratio of AUC Standard Deviation 0.232	0.744 Ratio of AUC Standard Deviation 0.307	0.833 Ratio of AUC Standard Deviation 0.0739	1.14 Ratio of AUC Standard Deviation 0.0991	1.37 Ratio of AUC Standard Deviation 0.278	1.04 Ratio of AUC Standard Deviation 0.731	0.712 Ratio of AUC Standard Deviation 0.205	0.829 Ratio of AUC Standard Deviation 0.177	0.723 Ratio of AUC Standard Deviation 0.315	0.987 Ratio of AUC Standard Deviation 0.35

SECONDARY outcome

Timeframe: cycle 4 (day 84)

Population: Pharmacokinetic analysis set

Phase Ib and Phase II: PK Parameters - Accumulation ratio (AR), which is the AUClast (multiple Dose)/AUClast (single dose) (for cycle 4 only) - PDR001

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=3 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=4 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=2 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=3 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=3 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=5 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=3 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=4 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=13 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR)	1.48 Ratio of AUC Standard Deviation 0.17	1.15 Ratio of AUC Standard Deviation 0.522	1.14 Ratio of AUC Standard Deviation 0.176	1.89 Ratio of AUC Standard Deviation 0.84	1.85 Ratio of AUC Standard Deviation 0.348	1.5 Ratio of AUC Standard Deviation 0.848	1.08 Ratio of AUC Standard Deviation 0.235	1.56 Ratio of AUC Standard Deviation 0.593	2.05 Ratio of AUC Standard Deviation 0.156	1.54 Ratio of AUC Standard Deviation 0.664

SECONDARY outcome

Timeframe: For ontreatment deaths: up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II. For total deaths: up to 3.8 years

Population: Clinical Database Population

On treatment deaths are reported from the start of treatment until end of study treatment plus 30 days, up to maximum duration of 116.4 weeks for phase Ib and 92.4 weeks for phase II. Deaths post treatment survival follow up are reported after the on-treatment period, up to a maximum timeframe of 46 months (3.8 years).

Outcome measures

Measure	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W n=6 Participants Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W n=12 Participants Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W n=13 Participants Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W n=6 Participants Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W n=11 Participants Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC n=21 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME n=20 Participants Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Phase Ib and Phase II: All Collected Deaths Total Deaths	6 Participants	12 Participants	10 Participants	12 Participants	4 Participants	10 Participants	11 Participants	19 Participants	14 Participants	11 Participants
Phase Ib and Phase II: All Collected Deaths On-treatment Deaths	0 Participants	1 Participants	4 Participants	4 Participants	1 Participants	4 Participants	1 Participants	3 Participants	0 Participants	2 Participants

Adverse Events

Ph Ib: MCS110@1 mg/kg Q3W@+ PDR001 100@mg Q3W

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 100@mg Q3W

Serious events: 4 serious events

Other events: 12 other events

Deaths: 1 deaths

Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 300@mg Q3W

Serious events: 4 serious events

Other events: 12 other events

Deaths: 4 deaths

Ph Ib: MCS110@5 mg/kg Q3W@+ PDR001 300@mg Q3W

Serious events: 7 serious events

Other events: 13 other events

Deaths: 4 deaths

Ph Ib: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Ph Ib: MCS110@10 mg/kg Q3W@+ PDR001 300@mg Q3W

Serious events: 5 serious events

Other events: 11 other events

Deaths: 4 deaths

Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - TNBC

Serious events: 8 serious events

Other events: 20 other events

Deaths: 1 deaths

Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - PC

Serious events: 14 serious events

Other events: 20 other events

Deaths: 3 deaths

Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - EC

Serious events: 8 serious events

Other events: 21 other events

Deaths: 0 deaths

Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - ME

Serious events: 7 serious events

Other events: 20 other events

Deaths: 2 deaths

Serious adverse events

Measure	Ph Ib: MCS110@1 mg/kg Q3W@+ PDR001 100@mg Q3W n=6 participants at risk Ph Ib: MCS110@1 mg/kg Q3W@+ PDR001 100@mg Q3W	Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 100@mg Q3W n=12 participants at risk Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 100@mg Q3W	Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 300@mg Q3W n=12 participants at risk Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 300@mg Q3W	Ph Ib: MCS110@5 mg/kg Q3W@+ PDR001 300@mg Q3W n=13 participants at risk Ph Ib: MCS110@5 mg/kg Q3W@+ PDR001 300@mg Q3W	Ph Ib: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W n=6 participants at risk Ph Ib: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W	Ph Ib: MCS110@10 mg/kg Q3W@+ PDR001 300@mg Q3W n=11 participants at risk Ph Ib: MCS110@10 mg/kg Q3W@+ PDR001 300@mg Q3W	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - TNBC n=20 participants at risk Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - TNBC	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - PC n=20 participants at risk Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - PC	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - EC n=21 participants at risk Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - EC	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - ME n=20 participants at risk Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - ME
General disorders Ulcer	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Ascites	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Constipation	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Dyspepsia	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Haemoperitoneum	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Intestinal perforation	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Large intestinal obstruction	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Nausea	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Rectal haemorrhage	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Vomiting	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Asthenia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Chills	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Fatigue	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders General physical health deterioration	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Generalised oedema	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Pyrexia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.4% 2/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Hepatobiliary disorders Bile duct obstruction	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Hepatobiliary disorders Cholecystitis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Hepatobiliary disorders Jaundice cholestatic	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Cystitis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Febrile infection	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Infection	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Peritonitis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Pneumonia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Sepsis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Skin infection	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Urinary tract infection	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Injury, poisoning and procedural complications Gastrointestinal procedural complication	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Alanine aminotransferase increased	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Aspartate aminotransferase increased	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Blood creatinine increased	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Fistula	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Nervous system disorders Cerebral infarction	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Nervous system disorders Seizure	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Product Issues Device breakage	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Renal and urinary disorders Anuria	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Renal and urinary disorders Renal failure	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Renal and urinary disorders Renal impairment	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Vascular disorders Deep vein thrombosis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Vascular disorders Hypertensive crisis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Vascular disorders Thrombosis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.

Other adverse events

Measure	Ph Ib: MCS110@1 mg/kg Q3W@+ PDR001 100@mg Q3W n=6 participants at risk Ph Ib: MCS110@1 mg/kg Q3W@+ PDR001 100@mg Q3W	Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 100@mg Q3W n=12 participants at risk Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 100@mg Q3W	Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 300@mg Q3W n=12 participants at risk Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 300@mg Q3W	Ph Ib: MCS110@5 mg/kg Q3W@+ PDR001 300@mg Q3W n=13 participants at risk Ph Ib: MCS110@5 mg/kg Q3W@+ PDR001 300@mg Q3W	Ph Ib: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W n=6 participants at risk Ph Ib: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W	Ph Ib: MCS110@10 mg/kg Q3W@+ PDR001 300@mg Q3W n=11 participants at risk Ph Ib: MCS110@10 mg/kg Q3W@+ PDR001 300@mg Q3W	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - TNBC n=20 participants at risk Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - TNBC	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - PC n=20 participants at risk Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - PC	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - EC n=21 participants at risk Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - EC	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - ME n=20 participants at risk Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - ME
Blood and lymphatic system disorders Anaemia	66.7% 4/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	23.1% 3/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	50.0% 3/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	27.3% 3/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	20.0% 4/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	30.0% 6/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	23.8% 5/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	35.0% 7/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.4% 2/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Cardiac disorders Tachycardia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Endocrine disorders Hypopituitarism	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Endocrine disorders Hypothyroidism	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	18.2% 2/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Eye disorders Dry eye	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Eye disorders Eye pruritus	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Eye disorders Eyelid oedema	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	18.2% 2/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Eye disorders Lacrimation increased	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	33.3% 4/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Eye disorders Panophthalmitis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Eye disorders Periorbital oedema	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	19.0% 4/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	30.0% 6/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Eye disorders Uveitis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Eye disorders Visual impairment	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Eye disorders Xerophthalmia	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Abdominal distension	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Abdominal pain	33.3% 2/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	23.1% 3/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	14.3% 3/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Abdominal pain lower	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Ascites	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Colitis	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Constipation	50.0% 3/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.4% 2/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	33.3% 2/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	30.0% 6/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	20.0% 4/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	19.0% 4/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 5/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Diarrhoea	50.0% 3/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	33.3% 2/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	27.3% 3/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	20.0% 4/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.5% 2/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Dry mouth	33.3% 2/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.4% 2/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Flatulence	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Gastritis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Psychiatric disorders Disorientation	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Gingival bleeding	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Haematochezia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Melaena	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Nausea	33.3% 2/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	41.7% 5/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	38.5% 5/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	54.5% 6/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	30.0% 6/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	40.0% 8/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	28.6% 6/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	20.0% 4/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Odynophagia	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Stomatitis	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	23.1% 3/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Gastrointestinal disorders Vomiting	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	41.7% 5/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	38.5% 5/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	20.0% 4/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.5% 2/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Adverse reaction	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Asthenia	50.0% 3/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	41.7% 5/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	23.1% 3/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	50.0% 3/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	45.5% 5/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.5% 2/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Chest discomfort	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Chills	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.4% 2/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	20.0% 4/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	14.3% 3/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	35.0% 7/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Face oedema	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	23.1% 3/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	14.3% 3/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	30.0% 6/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Fatigue	33.3% 2/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	41.7% 5/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.4% 2/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	33.3% 2/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 5/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	19.0% 4/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	20.0% 4/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Gait disturbance	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders General physical health deterioration	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	33.3% 2/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Generalised oedema	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Influenza like illness	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Non-cardiac chest pain	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Oedema peripheral	33.3% 2/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.4% 2/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	14.3% 3/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Pyrexia	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	33.3% 4/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	45.5% 5/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	20.0% 4/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	20.0% 4/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	40.0% 8/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
General disorders Suprapubic pain	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Hepatobiliary disorders Cholestasis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Hepatobiliary disorders Hyperbilirubinaemia	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Immune system disorders Cytokine release syndrome	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Abscess	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Cellulitis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Conjunctivitis	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Diarrhoea infectious	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Helicobacter infection	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Infection	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Influenza	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Nasopharyngitis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Otitis media	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Peritonitis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Pneumonia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Pyuria	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.4% 2/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Respiratory tract infection	33.3% 2/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Skin infection	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Upper respiratory tract infection	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	18.2% 2/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Urinary tract infection	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	33.3% 2/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.5% 2/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Infections and infestations Viral skin infection	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Injury, poisoning and procedural complications Abdominal injury	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Injury, poisoning and procedural complications Fall	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Injury, poisoning and procedural complications Infusion related reaction	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	14.3% 3/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Injury, poisoning and procedural complications Post procedural inflammation	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Injury, poisoning and procedural complications Procedural pain	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Injury, poisoning and procedural complications Rib fracture	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Alanine aminotransferase increased	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	18.2% 2/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	20.0% 4/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 5/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	33.3% 7/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	20.0% 4/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Amylase increased	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Aspartate aminotransferase increased	66.7% 4/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	38.5% 5/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	50.0% 3/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	36.4% 4/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	45.0% 9/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	35.0% 7/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	61.9% 13/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	50.0% 10/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Blood alkaline phosphatase increased	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.4% 2/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	14.3% 3/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Blood bilirubin increased	50.0% 3/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.4% 2/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Blood creatine phosphokinase increased	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	23.1% 3/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	66.7% 4/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	27.3% 3/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	45.0% 9/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	50.0% 10/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	57.1% 12/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	70.0% 14/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Blood creatinine increased	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.5% 2/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Blood lactate dehydrogenase increased	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.5% 2/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 5/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Blood pressure increased	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Blood thyroid stimulating hormone increased	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations C-reactive protein increased	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Lipase increased	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Lymphocyte count decreased	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Neutrophil count increased	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Platelet count decreased	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Transaminases increased	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Investigations Weight decreased	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Decreased appetite	50.0% 3/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	58.3% 7/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	33.3% 4/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	36.4% 4/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	35.0% 7/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	20.0% 4/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Hyperuricaemia	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Hypoalbuminaemia	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	33.3% 2/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.4% 2/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Hypomagnesaemia	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Hyponatraemia	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.5% 2/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Hypophagia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Hypophosphataemia	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	30.8% 4/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	33.3% 2/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	33.3% 4/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Groin pain	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Joint warmth	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Muscular weakness	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	20.0% 4/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.5% 2/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	14.3% 3/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Nervous system disorders Balance disorder	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Nervous system disorders Dizziness	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.4% 2/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.5% 2/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Nervous system disorders Dysgeusia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Nervous system disorders Headache	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 5/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	14.3% 3/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Nervous system disorders Hypoaesthesia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Nervous system disorders Neuropathy peripheral	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Nervous system disorders Paraesthesia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Nervous system disorders Somnolence	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Psychiatric disorders Anxiety	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	14.3% 3/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Psychiatric disorders Confusional state	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Psychiatric disorders Depression	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Psychiatric disorders Eating disorder	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Psychiatric disorders Insomnia	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.5% 2/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Renal and urinary disorders Choluria	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Renal and urinary disorders Dysuria	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Renal and urinary disorders Haematuria	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Renal and urinary disorders Pollakiuria	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Renal and urinary disorders Proteinuria	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.5% 2/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Renal and urinary disorders Renal colic	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Renal and urinary disorders Renal failure	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Renal and urinary disorders Ureterolithiasis	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Reproductive system and breast disorders Breast pain	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Reproductive system and breast disorders Varicocele	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Aphonia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	25.0% 3/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 2/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	14.3% 3/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Lung opacity	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Nasal mucosal ulcer	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Pneumonitis	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	4.8% 1/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Rhinalgia	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Skin and subcutaneous tissue disorders Dry skin	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Skin and subcutaneous tissue disorders Hair colour changes	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Skin and subcutaneous tissue disorders Hyperhidrosis	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Skin and subcutaneous tissue disorders Nail dystrophy	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Skin and subcutaneous tissue disorders Pruritus	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.5% 2/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 2/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	15.0% 3/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.5% 2/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	20.0% 4/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.5% 2/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	10.0% 2/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Vascular disorders Deep vein thrombosis	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	0.00% 0/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.
Vascular disorders Hypertension	0.00% 0/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	8.3% 1/12 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	7.7% 1/13 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	16.7% 1/6 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.1% 1/11 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	5.0% 1/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	9.5% 2/21 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.	20.0% 4/20 • On-treatment adverse events are reported, from first dose of study treatment until end of study treatment plus 30 days, up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: Novartis.email@Novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER