Dose Escalation of DF6002 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications

Summary

Participation Requirements

Description

This study is a Phase 1/2, open-label, dose-escalation study with a consecutive parallel-group efficacy expansion study, designed to determine the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of DF6002 as monotherapy and in combination with nivolumab. The study con...

This study is a Phase 1/2, open-label, dose-escalation study with a consecutive parallel-group efficacy expansion study, designed to determine the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of DF6002 as monotherapy and in combination with nivolumab. The study consists of 3 parts: Phase 1: Dose-escalation as a monotherapy using a 3+3 design, with Phase 1 Cohort Expansion. Phase 1b: Dose-escalation as a combination with nivolumab using a 3+3 design, with Phase 1b Cohort Expansion. Phase 2: Efficacy Expansion using a group sequential design. In Phase 2, DF6002 will be evaluated as a monotherapy in the following indications: Cohort 2A: Advanced (unresectable or metastatic) melanoma. Cohort 2B: Advanced (unresectable or metastatic) non-small cell lung cancer (NSCLC). In Phase 2, DF6002 will be evaluated in combination with nivolumab in the following indication: Cohort 2C: Advanced (unresectable or metastatic) melanoma. Cohort 2D: Advanced (unresectable or metastatic) NSCLC. In each study phase, patients will receive DF6002 on Day 1 every 4 weeks (Q4W). Patients will receive DF6002 until confirmed progressive disease (PD), unacceptable toxicity (ie, dose-limiting toxicity [DLT]), or any reason for withdrawal from the study or Investigational Medicinal Product (IMP) occurs.

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