A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Key facts
- Where
- Toronto, KanadaSee the 2 sites
- Phase
- 2. fázis
Where in Kanada
- Princess Margaret Cancer CenterToronto, KanadaTaking people
- Sunnybrook Health Sciences CentreToronto, KanadaTaking 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
- NCT07644559
- Record updated
- 2026. november 6.
- Original description
This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic CancerRead full original descriptionShow less
A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and With Cetuximab, in Patients With Metastatic KRAS G12D-Mutated Pancreatic Cancer (TARGET-D 201)
This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer
Inclusion: Histologic or cytologic confirmed PDAC; Measurable disease per RECIST 1.1; Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing); ECOG PS=0 or 1; Adequate organ function; VS-7375 + cetuximab (2L PDAC) :; -Received only 1 prior Tx in the metastatic setting; prior adjuvant counts as a line if progressed within 6 months; VS-7375 + cetuximab (1L PDAC) :; -Treatment-naïve or received ≤ 1 cycle of SoC 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; RT to brain or lung within 2 weeks of first treatment dose; Receipt of prior direct RAS inhibitor; 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; History of drug-induced Interstitial Lung Disease; Have any documented co-existing pathogenic or likely pathogenic RAS mutation(s) in KRAS; Untreated or symptomatic CNS metastasis; Receipt of PPI, P-CABs, or H2 blocker within 5 days; Other protocol-defined inclusion/exclusion criteria may apply.