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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: 03 Jul 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; Registrational; Therapeutic Use
  • Acronyms TARGET-D 101
  • Sponsors Verastem Oncology

Most Recent Events

  • 23 Jun 2026 According to a Verastem Oncology Media Release, company look forward to sharing additional data on VS-7375 in patients with KRAS G12D-mutated cancers later this year. Company will report an update on the this trial in 2H 2026. Complete target enrollment in TARGET-D 101 PDAC and NSCLC monotherapy cohorts and mCRC cetuximab combination cohorts by the end of June 2026.
  • 23 Jun 2026 Results presented in a Verastem Oncology media release.
  • 16 Jun 2026 According to a Verastem Oncology Media Release, enrollment is ongoing with monotherapy dose escalation progressing from 400 mg through 900 mg QD doses without dose-limiting toxicities or major safety concerns observed to date. The study is currently evaluating a 1200 mg QD monotherapy dose and a 900 mg QD dose of VS-7375 in combination with full-dose cetuximab, as well as combinations with either gemcitabine plus nab-paclitaxel or carboplatin/pemetrexed/pembrolizumab.

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