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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

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Trial Profile

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: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 21 Mar 2025

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At a glance

  • Drugs DF 1001 (Primary) ; Sacituzumab govitecan (Primary) ; Nivolumab; Paclitaxel; Pembrolizumab
  • Indications Advanced breast cancer; Bladder cancer; Carcinoma; Colorectal cancer; Gastric cancer; HER2 negative breast cancer; HER2 positive breast cancer; Non-small cell lung cancer; Oesophageal cancer; Renal cancer; Solid tumours; Triple negative breast cancer; Ureteral neoplasms; Urethral cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Dragonfly Therapeutics

Most Recent Events

  • 15 Feb 2024 According to a Dragonfly Therapeutics media release, company to collaborate with Gilead to study combine DF1001 and Trodelvy in metastatic breast cancer and NSCLC. Dragonfly will have operational control of the study and first patients are expected to receive this combination in Q2 2024. Clinical trial sites are currently open in the U.S., France, Belgium, Denmark and the Netherlands. Additional sites in North America, Europe and Asia Pacific will open in 2024.
  • 25 Jan 2024 Planned number of patients changed from 490 to 378.
  • 25 Jan 2024 Protocol amended to change number of treatment arms from 17 to 22. Combo Therapy with DF1001 and Sacituzumab Govitecan-hziy to be evaluated, primary endpoint added. Planned patient number changed.

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