Primary Outcome Measures
Parts A, A2, A3, B1, C1, C2, C3, C4, C5 and C6: Number of Participants with Treatment Emergent Adverse Events and Serious Adverse Events [Time Frame: Part A, A2, A3, B1: From baseline until 14 days after discontinuation of study treatment (assessed up to approximately 6 years); Part C1, C2, C3, C4, C5, C6: up to 30 days after discontinuation of study treatment (assessed up to approximately 6 years)] [Designated as safety issue: ]
Parts A, A2, A3, B1, C1, C2, C3, C4, C5 and C6: Number of Participants with Clinically Significant Changes in Clinical Laboratory Values (Serum Chemistry and Hematology), Vital Signs, and Electrocardiogram (ECG) Assessments [Time Frame: Part A, A2, A3, B1: From baseline until 14 days after discontinuation of study treatment (assessed up to approximately 6 years); Part C1, C2, C3, C4, C5, C6: up to 30 days after discontinuation of study treatment (assessed up to approximately 6 years)] [Designated as safety issue: ]
Part A, A2 and A3: Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 (RP2D) of Single-Agent M4344 Administered BIW or BID or Once Daily or Drug Holiday Schedule [Time Frame: Evaluation for dose-limiting toxicity will be during Cycle 1 (each cycle is of 21 days) for each participant] [Designated as safety issue: ]
Part B1: Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 (RP2D) of M4344 Administered in Combination with Carboplatin [Time Frame: Evaluation for dose-limiting toxicity will be during Cycle 1 (each cycle is of 21 days) for each participant] [Designated as safety issue: ]
Part C1, C2, C3, C4, C5 and C6: Proportion of Participants With Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Assessed by the Investigator [Time Frame: Baseline until disease progression or start of new anti-cancer treatment line (approximately up to 6 years)] [Designated as safety issue: ]
Secondary Outcome Measures
Part A: Area Under the Concentration Curve (AUC) of M4344 [Time Frame: Cycle 1, Day 1 up to Cycle 1, Day 15 (each cycle is of 21 days)] [Designated as safety issue: ]
Part A: Maximum Observed Plasma Concentration (Cmax) of M4344 [Time Frame: Cycle 1, Day 1 up to Cycle 1, Day 15 (each cycle is of 21 days)] [Designated as safety issue: ]
Part A: Time to Reach Maximum Plasma Concentration (tmax) of M4344 [Time Frame: Cycle 1, Day 1 up to Cycle 1, Day 15 (each cycle is of 21 days)] [Designated as safety issue: ]
Part A2 and A3: Area Under the Concentration Curve (AUC) of M4344 and Metabolites [Time Frame: Cycle 1, Day 1 up to Cycle 1, Day 15 (each cycle is of 21 days)] [Designated as safety issue: ]
Part A2 and A3: Maximum Observed Plasma Concentration (Cmax) of M4344 and Metabolites [Time Frame: Cycle 1, Day 1 up to Cycle 1, Day 15 (each cycle is of 21 days)] [Designated as safety issue: ]
Part A2 and A3: Time to Reach Maximum Plasma Concentration (tmax) of M4344 and Metabolites [Time Frame: Cycle 1, Day 1 up to Cycle 1, Day 15 (each cycle is of 21 days)] [Designated as safety issue: ]
Parts A, A2, A3 and B1: Objective Tumor Response (OR) and Disease Stabilization (SD) as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [Time Frame: Every 2 Cycles (each cycle is of 21 days) until tumor progression (approximately up to 6 years)] [Designated as safety issue: ]
Part B1: Area Under the Concentration Curve (AUC) of M4344 [Time Frame: Cycle 1, Day 2 up to Cycle 1, Day 9 (each cycle is of 21 days)] [Designated as safety issue: ]
Part B1: Maximum Observed Plasma Concentration (Cmax) of M4344 [Time Frame: Cycle 1, Day 2 up to Cycle 1, Day 9 (each cycle is of 21 days)] [Designated as safety issue: ]
Part B1: Time to Reach Maximum Plasma Concentration (tmax) of M4344 [Time Frame: Cycle 1, Day 2 up to Cycle 1, Day 9 (each cycle is of 21 days)] [Designated as safety issue: ]
Part C1, C2, C3, C4, C5 and C6: Confirmed Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Assessed by Investigator [Time Frame: Baseline, until disease progression or start of new anti-cancer treatment line (approximately up to 6 years)] [Designated as safety issue: ]
Part C1, C2, C3, C4, C5 and C6: Duration of Response Assessed From Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [Time Frame: Baseline until PD, death, or last adequate tumor assessment (approximately up to 6 years)] [Designated as safety issue: ]
Part C1, C2, C3, C4, C5 and C6: Progression Free Survival (PFS) as Evaluated by RECIST Version 1.1 [Time Frame: Baseline until tumor progression (approximately up to 6 years)] [Designated as safety issue: ]
Part C1, C2, C3, C4, C5 and C6: Overall Survival (OS) [Time Frame: Assessed every 3 months for up to 1 year or more or until study closure, whichever comes first (approximately up to 6 years)] [Designated as safety issue: ]
Part C1, C2, C3, C4, C5 and C6: Area Under the Concentration Curve (AUC) of M4344 and Metabolites [Time Frame: Cycle 1, Day 1 up to Cycle 12, Day 1 (each cycle is of 21 days)] [Designated as safety issue: ]
Part C1, C2, C3, C4, C5 and C6: Maximum Observed Plasma Concentration (Cmax) of M4344 and Metabolites [Time Frame: Cycle 1, Day 1 up to Cycle 12, Day 1 (each cycle is of 21 days)] [Designated as safety issue: ]
Part C1, C2, C3, C4, C5 and C6: Time to Reach Maximum Plasma Concentration (tmax) of M4344 and Metabolites [Time Frame: Cycle 1, Day 1 up to Cycle 12, Day 1 (each cycle is of 21 days)] [Designated as safety issue: ]