A Phase 1 Dose-Escalation and Expansion Study to Assess Safety and Preliminary Antitumor Activity of Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy
The primary purpose of part 1 (dose escalation) of this study is to identify the recommended dose and to characterize the safety and tolerability of Debio 0123 in combination with carboplatin and etoposide. The primary purpose of part 2 (dose expansion) of this study is to characterize the safety and tolerability of Debio 0123 at the recommended dose when administered in combination with carboplatin and etoposide.
• Histologically or cytologically confirmed SCLC
• Tumor that is not bleeding
• Prior platinum-based chemotherapy (carboplatin and/or cisplatin)
‣ Part 1 (dose escalation): Recurrence or progression after a minimum of 45 days since the last dose of prior standard platinum-based therapy
⁃ Part 2 (expansion): Recurrence or progression after a minimum of 90 days since the last dose of prior standard platinum-based therapy
• Measurable disease per RECIST 1.1
• Willingness and ability to undergo tumor biopsy unless an archived tumor sample is available
• ECOG performance status of 0-1
• Life expectancy of at least 3 months in the best judgment of the Investigator
• Adequate bone marrow, hepatic and renal function, adequate coagulation status
• Willingness and ability to comply with scheduled visits, study treatment plans, laboratory tests, and other study procedures.