NCT04423029

A Study of DF6002 Alone and in Combination With Nivolumab

A Phase 1/1b, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Dragonfly Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects and preliminary anti-tumor activity of DF6002 alone and in combination with Nivolumab in participants with advanced solid tumors.

Detailed description

Assess the safety and tolerability of subcutaneous (SC) and intravenous (IV) administration of DF6002, as monotherapy and in combination with nivolumab, and to determine the maximum tolerated dose (MTD) and recommended efficacy expansion dose (REED) of SC and IV DF6002, both as monotherapy and in combination with nivolumab, for patients with advanced (unresectable, recurrent, or metastatic) solid tumors.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	DF6002	Specified dose on specified days
DRUG	Nivolumab	Specified dose on specified days

Timeline

• Start date: 2020-07-13
• Primary completion: 2025-11-26
• Completion: 2025-11-26
• First posted: 2020-06-09
• Last updated: 2026-03-18

Locations

32 sites across 4 countries: United States, Australia, France, Spain

Regulatory

• FDA-regulated drug study