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A Phase 1/2a, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients With Advanced KRAS G12D-Mutated Solid Tumors

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Trial Profile

A Phase 1/2a, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients With Advanced KRAS G12D-Mutated Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 14 Oct 2025

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At a glance

  • Drugs Carboplatin (Primary) ; Cetuximab (Primary) ; Gemcitabine (Primary) ; Paclitaxel (Primary) ; Pembrolizumab (Primary) ; Pemetrexed (Primary) ; VS 7375 (Primary)
  • Indications Adenocarcinoma; Colorectal cancer; Non-small cell lung cancer; Pancreatic ductal carcinoma; Solid tumours
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Verastem Oncology

Most Recent Events

  • 01 Oct 2025 Treatments section is updated to increase the number of treatment arms from 4 to 10 by the addition of 6 more experimental arms, with more drugs added a combination therapy with the study drug.
  • 01 Oct 2025 Planned number of patients changed from 130 to 330.
  • 24 Jul 2025 According to a Verastem Oncology media release, the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to VS-7375 for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic PDAC who have received at least one prior line of standard systemic therapy.

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