Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
260

Summary

Conditions
  • Head and Neck Squamous Cell Carcinoma
  • Endometrial Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Lung Cancer
  • Melanoma
  • Ovarian Cancer
  • Urothelial Carcinoma
  • Prostate Cancer
  • Renal Cell Carcinoma
  • Solid Tumor
  • Triple -Negative Breast Cancer
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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.

Tracking Information

NCT #
NCT04423029
Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Tapan Maniar, MD Dragonfly Therapeutics