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A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 as Monotherapy and in Combination With Docetaxel in Participants With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation

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Trial Profile

A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 as Monotherapy and in Combination With Docetaxel in Participants With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 23 Mar 2025

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At a glance

  • Drugs PRT 3789 (Primary) ; Docetaxel
  • Indications Advanced breast cancer; Gastric cancer; Non-small cell lung cancer; Oesophageal cancer; Pancreatic cancer; Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Prelude Therapeutics

    • Most Recent Events

    • 10 Mar 2025 Interim results presented in a Prelude Therapeutics media release
    • 10 Mar 2025 According to a Prelude Therapeutics media release, company presented an encore oral presentation from this trial (PRT3789 plus docetaxel combination dose escalation arm of the trial through the first three cohorts (500 mg + docetaxel)) at the 2025 Japanese Society of Medical Oncology Annual Meeting on 8 Mar 2025.
    • 10 Mar 2025 According to a Prelude Therapeutics media release, company is nearing conclusion of monotherapy dose escalation which is now at the 665 mg once weekly IV dose and identifying dose(s) for advancement to any potential future trials. In addition, enrollment of patients in dose escalation in the combination of PRT3789 with docetaxel is ongoing.

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