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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: 19 Nov 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

  • 23 Oct 2025 According to a Verastem Oncology media release, following the ongoing monotherapy dose escalation to 900 mg QD, the Company expects to select the recommended Phase 2 dose and advance subsequent efficacy and safety analysis of monotherapy VS-7375 in patient expansion cohorts with advanced PDAC and NSCLC.
  • 23 Oct 2025 According to a Verastem Oncology media release, Enrollment initiated for VS-7375 in combination with cetuximab in patients with advanced KRAS G12D mutant solid tumors, including colorectal cancerPlan to report an interim safety and efficacy update on the Phase 1/2a trial in the first half of 2026
  • 23 Oct 2025 Preliminary results published in the Verastem Oncology Media Release.

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