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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: 21 Feb 2026

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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

  • 04 Feb 2026 According to a Verastem Oncology media release, the company expects to select the RP2D and plan to initiate the PDAC and NSCLC combination expansion cohorts in 2H 2026.
  • 04 Feb 2026 According to a Verastem Oncology media release, the company expects to complete enrollment in combination dose-escalation cohorts in mid-2026 and in combination dose-escalation cohorts in mid-2026.
  • 04 Feb 2026 According to a Verastem Oncology media release, the company expects to select the recommended Phase 2 dose (RP2D) with cetuximab and initiate the CRC combination expansion cohort in 1H 2026 and Engage with the FDA to discuss its development path forward, including potential registration-directed clinical trials in PDAC, NSCLC, and CRC.

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