RecruitingPhase 2NCT07644559
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
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)
Sponsor
Verastem, Inc.
Enrollment
180 participants
Start Date
Jun 1, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Min Age: 18 Years
Inclusion Criteria9
- Histopathology 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 Criteria10
- Have any other documented co-existing common RAS mutation(s)
- 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
- History of drug-induced Interstitial Lung Disease
- Receipt of prior direct RAS inhibitor
- Untreated or symptomatic CNS metastasis
- 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
- Receipt of PPI or H2 blocker within 5 days
- Inability to swallow oral medication
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Interventions
DRUGVS-7375
Taken by mouth
DRUGcetuximab
Subcutaneous infusion
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07644559
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