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An Open-Label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GFH375 in Patients With KRAS G12D Mutant Advanced Solid Tumors

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Trial Profile

An Open-Label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GFH375 in Patients With KRAS G12D Mutant Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 28 Apr 2025

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At a glance

  • Drugs GFH 375 (Primary)
  • Indications Adenocarcinoma; Colorectal cancer; Non-small cell lung cancer; Pancreatic ductal carcinoma; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors GenFleet Therapeutics

Most Recent Events

  • 23 Apr 2025 According to Verastem Oncology media release, company announced the acceptance of an abstract, by their partner GenFleet Therapeutics, for rapid oral presentation of the preliminary dose escalation phase of the Phase 1/2 study of VS-7375 (also known as GFH375) conducted by GenFleet at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting being held on May 30-June 3, 2025, in Chicago, IL.
  • 23 Apr 2025 According to Verastem Oncology media release, company announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of VS-7375, an oral KRAS G12D (ON/OFF) inhibitor for clinical evaluation. The Company expects to initiate a Phase 1/2a study in mid-2025 with plans for multiple expansion cohorts, including combinations, in advanced solid tumors, such as pancreatic cancer, colorectal cancer, and non-small cell lung cancer.
  • 02 Apr 2025 Planned number of patients changed from 290 to 390.

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