NCT06108479

Study of DF6215 in Patients With Advanced Solid Tumors

A Phase I/Ib, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 Monotherapy and in Combination Therapy in Patients With Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Dragonfly Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase I/Ib, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 Monotherapy and in Combination Therapy in Patients with Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors; is designed to assess the safety, tolerability, and preliminary efficacy of DF6215 alone or in combination with pembrolizumab in patients with advanced solid tumors. The study is open-label, meaning both participants and investigators are aware of the treatment being administered.

Detailed description

This Phase I/Ib trial involves multiple parts and includes both dose-escalation and dose-expansion phases. The primary objectives are to evaluate the safety and tolerability of DF6215, an investigational biologic agent, when administered either as a monotherapy or in combination with pembrolizumab, a known immunotherapy drug, and evaluate the clinical activity of DF6215 monotherapy and in combination with pembrolizumab. Secondary objectives include assessing pharmacokinetics, pharmacodynamics, and preliminary efficacy based on tumor response using RECIST 1.1 criteria. The trial will enroll adult patients with advanced (unresectable, recurrent, or metastatic) solid tumors, and the study design allows for dose modifications based on safety monitoring and the occurrence of dose-limiting toxicities (DLTs). The trial will also incorporate a safety monitoring committee to review data at regular intervals to ensure patient safety .

Conditions

• Solid Tumor, Adult
• Solid Tumor Cancer

Interventions

Type	Name	Description
DRUG	DF6215	Immunotherapy (cytokine) targeting effector cells.
DRUG	pembrolizumab	Anti-PD-1 immunotherapy agent
DRUG	KEYTRUDA®	Anti-PD-1 immunotherapy agent

Timeline

• Start date: 2023-11-28
• Primary completion: 2025-12-04
• Completion: 2025-12-04
• First posted: 2023-10-31
• Last updated: 2026-03-18

Locations

21 sites across 3 countries: United States, Australia, France

Regulatory

• FDA-regulated drug study