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.
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 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) renal cell carcinoma (RCC).
In Phase 2, DF6002 will be evaluated in combination with nivolumab in the following
indication
Cohort C: Advanced (unresectable or metastatic) urothelial carcinoma.
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.
Details
Treatment
Pembrolizumab,
Nivolumab,
DF6002
Clinical Study Identifier
NCT04423029
Sponsor
Dragonfly Therapeutics
Last Modified on
25 January 2021
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