NCT05597839

Study of DF9001 in Patients With Advanced Solid Tumors

A Phase 1/1b First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF9001 as a Monotherapy and in Combination Therapies in Patients With Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors, and Expansion in Selected Indications

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Dragonfly Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

DF9001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express epidermal growth factor receptor (EGFR). The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having selected solid tumors (monotherapy and in combination with pembrolizumab).

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	DF9001	Immunotherapy agent targeting NK cells.
DRUG	KEYTRUDA® (pembrolizumab)	Anti-PD-1 immunotherapy agent

Timeline

• Start date: 2022-11-15
• Primary completion: 2025-08-15
• Completion: 2025-08-15
• First posted: 2022-10-28
• Last updated: 2025-10-29

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study