A Dose-Finding Study of the Second Mitochondrial Activator of Caspases (SMAC) Mimetic Debio 1143 When Given in Combination With Avelumab to Participants With Advanced Solid Malignancies and to Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Platinum-Based Therapy

Official Title

A Phase-Ib Dose-Finding Study of the SMAC Mimetic Debio 1143 When Given in Combination With the Anti-PD-L1 Antibody Avelumab to Patients With Advanced Solid Malignancies and, in an Expansion Cohort, to Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Platinum-Based Therapy

Summary:

The study is primarily designed to assess the safety and tolerability of escalating oral doses of Debio 1143 and preliminary anti-tumour activity when combined with the standard dose of avelumab in participants with advanced solid malignancies.

Trial Description

Primary Outcome:

  • Part A: Maximum Tolerated Dose (MTD)
  • Part B: Objective Response Rate (ORR)
Secondary Outcome:
  • Part A and B: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
  • Part A and B: Change in Tumour Size
  • Part A and B: Objective Response Rate
  • Part A and B: Best Overall Response (BOR)
  • Part A and B: Duration of Response
  • Part A and B: Disease Control Rate
  • Part A and B: Progression Free Survival (PFS)
  • Part A and B: Overall Survival (OS)
  • Part A and B: Assessment of Pharmacokinetic Parameters

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society