Primary Outcome Measures
Number of Participants with Dose-limiting Toxicities (DLTs) [Time Frame: Phase 1 Cycle 1 (28 days)] [Designated as safety issue: ]
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: Phase 1 and 2 continuously throughout the study until 28 days after treatment discontinuation (up to 36 months)] [Designated as safety issue: ]
Secondary Outcome Measures
Area under the Plasma Concentration-time Curve from Time 0 Through the Last Measurable Point (AUC0-t) of H3B-6545 [Time Frame: Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose] [Designated as safety issue: ]
Mean Maximum Observed Plasma Concentration (Cmax) of H3B-6545 [Time Frame: Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 (pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose] [Designated as safety issue: ]
Time of Maximum Observed Plasma Concentration (tmax) of H3B-6545 [Time Frame: Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose] [Designated as safety issue: ]
Objective Response Rate (ORR) [Time Frame: Phase 1 and 2 up to approximately 36 months] [Designated as safety issue: ]
Duration of Response (DoR) [Time Frame: Phase 1 and 2 up to approximately 36 months] [Designated as safety issue: ]
Disease Control Rate (DCR) [Time Frame: Phase 1 and 2 up to approximately 36 months] [Designated as safety issue: ]
Clinical Benefit Rate (CBR) [Time Frame: Phase 1 and 2 up to approximately 36 months] [Designated as safety issue: ]
Progression-free survival (PFS) [Time Frame: Phase 1 and 2 up to approximately 36 months] [Designated as safety issue: ]
Overall Survival (OS) [Time Frame: Phase 1 and 2 up to approximately 36 months] [Designated as safety issue: ]