NCT04143711

Study of DF1001 in Patients With Advanced Solid Tumors

A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Dragonfly Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

DF1001-001 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 human epidermal growth factor receptor 2 (HER2). 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 either HER2 activated non-small cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 + sacituzumab govitecan-hziy.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	DF1001	Immunotherapy agent targeting NK cells.
DRUG	Nivolumab	Anti-PD-1 immunotherapy agent
DRUG	Nab paclitaxel	A chemotherapy treatment combining paclitaxel with albumin
DRUG	Sacituzumab Govitecan-hziy	A Trop-2 (Tumor-associated calcium signal transducer 2) directed antibody and topoisomerase inhibitor drug conjugate

Timeline

• Start date: 2019-11-11
• Primary completion: 2025-12-05
• Completion: 2025-12-05
• First posted: 2019-10-29
• Last updated: 2026-03-18

Locations

44 sites across 6 countries: United States, Belgium, Denmark, France, Netherlands, South Korea

Regulatory

• FDA-regulated drug study