Tests VS-7375 in adults with KRAS G12D-mutated metastatic colorectal cancer
Tests VS-7375, alone or with other drugs, in adults with colorectal cancer.
Plain-language title generated from the registry record
Registry title: A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer
Key facts
- Where
- Hobart, Hyde Park, Kurralta Park, Macquarie Park, Melbourne, South Brisbane, and Waratah, AustraliaSee the 7 sites
- Phase
- Phase 2
Where in Australia
- Icon Cancer Centre HobartHobart, AustraliaTaking people
- Icon Cancer Centre TownsvilleHyde Park, AustraliaTaking people
- Icon Cancer Centre AdelaideKurralta Park, AustraliaTaking people
- Macquarie University HospitalMacquarie Park, AustraliaTaking people
- Alfred HospitalMelbourne, AustraliaTaking people
- Icon Cancer Centre South BrisbaneSouth Brisbane, AustraliaTaking people
- Calvary Mater NewcastleWaratah, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Verastem, Inc.
- Trial code
- NCT07659795EU 2026-526473-42-00
- Record updated
- 26 October 2026
- Original description
This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab or panitumumab and cetuximab plus mFOLFOX in patients with metastatic KRAS G12D - mutated Colorectal CancerRead full original descriptionShow less
A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, With and Without an Anti-EGFR Antibody, and With an Anti-EGFR Antibody and Chemotherapy, in Patients With Metastatic KRAS G12D-Mutated Colorectal Adenocarcinoma (TARGET-D 203)
This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab or panitumumab and cetuximab plus mFOLFOX in patients with metastatic KRAS G12D - mutated Colorectal Cancer
Inclusion: Histopathology confirmed metastatic CRC; Measurable disease per RECIST 1.1; Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing); ECOG PS=0 or 1; 2L+ patients:; Must have received at least 1 standard chemotherapy for metastatic colorectal adenocarcinoma; Have documented disease progression during or following their most recent prior line of therapy; Have either stable disease, partial response (PR), or complete response (CR) by RECIST v1.1 as the best overall response (BOR) during at least 1 prior systemic therapy; 1L patients:; Treatment-naïve or received no more than 1 cycle of standard systemic therapy for metastatic disease.
Exclusion: Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter; Major surgery within 4 weeks of first treatment dose; Radiation therapy (RT) within 1 week of first treatment dose; Receipt of prior direct RAS inhibitor; Receipt of more than 1 investigational therapy; Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter; Inability to swallow oral medication; Have any other documented co-existing common RAS mutation(s); Untreated or symptomatic CNS metastasis; Receipt of PPI or H2 blocker within 5 days; Other protocol-defined inclusion/exclusion criteria may apply.