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 pembrolizumab.
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 pembrolizumab 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) renal cell carcinoma (RCC).
In Phase 2, DF6002 will be evaluated in combination with pembrolizumab in the following
indicationCohort C: Advanced (unresectable or metastatic) urothelial carcinoma.
In each study phase, patients will receive DF6002 on Day 1 every 3 weeks (Q3W). 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.
