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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

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Trial Profile

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: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 22 May 2024

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At a glance

  • Drugs DF-9001 (Primary) ; Nivolumab (Primary) ; Pembrolizumab (Primary)
  • Indications Carcinoma; Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Mouth neoplasm; Non-small cell lung cancer; Oropharyngeal cancer; Renal cell carcinoma; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Dragonfly Therapeutics

Most Recent Events

  • 21 May 2024 According to a Dragonfly Therapeutics media release, first patients are expected to receive DF9001 in combination with pembrolizumab in Q4 2024. Clinical trial sites are currently open for monotherapy dosing in the U.S., with additional sites in North America and Europe expected to open in 2024.
  • 21 May 2024 According to a Dragonfly Therapeutics media release, company announced that it has entered into a clinical collaboration with Merck (known as MSD outside the US and Canada), to evaluate DF9001, Dragonfly's EGFR immune engager, in combination with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced solid tumors expressing EGFR.
  • 13 May 2024 Planned number of patients changed from 362 to 242.

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