NCT03270176

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Neoplasms

Interventions

Type	Name	Description
DRUG	Debio 1143	Debio 1143 100 to 250 mg, capsule orally for 10 days every 2 weeks.
DRUG	Avelumab	Avelumab 10 mg/kg intravenous infusion every 2 weeks.

Timeline

• Start date: 2017-10-10
• Primary completion: 2022-03-22
• Completion: 2022-03-22
• First posted: 2017-09-01
• Last updated: 2022-06-01

Locations

9 sites across 3 countries: Canada, Poland, Romania