This study has two parts: Part 1 and Part 2. The purpose of this study in Part 1, Dose Escalation Part is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of Debio 0123 as monotherapy with repeated dosing in adults with advanced solid tumors that recurred or progressed after prior therapy and/or for whom no standard therapy of proven benefit is available. The purpose in Part 2, Expansion Part of this study, is to characterize the safety and tolerability of Debio 0123 in each study arm and overall when administered as monotherapy at the MTD/RP2D determined during the Dose Escalation Part 1 and to evaluate the preliminary anti-tumor activity of Debio 0123 when administered as monotherapy to participants in each study arm.
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Part 1: Maximum Tolerated Dose (MTD) as Determined by Percentage of Participants with Dose Limiting Toxicities (DLTs)
Timeframe: Cycle 1 (each cycle is 21 days)
Part 1: Recommended Phase 2 Dose (RP2D) as Determined by Percentage of Participants with DLTs and Cumulative Safety Data
Timeframe: Cycle 1 (each cycle is 21 days)
Part 2: Percentage of Participants with Serious Adverse Events (SAEs)
Timeframe: Up to 30 days after the last dose of study treatment (up to 13 months)
Part 2: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Laboratory Abnormalities
Timeframe: Up to 30 days after the last dose of study treatment (up to 13 months)
Part 2: Percentage of Participants with Treatment Discontinuations and Treatment Modifications due to Adverse Events (AEs) and Laboratory Abnormalities
Timeframe: Up to end of study treatment (up to 12 months)
Part 2: Overall Response Rate (ORR)
Timeframe: From the start of study treatment until disease progression (up to 12 months)