NCT07644559
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentVerastem, Inc.
~180 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:VS-7375cetuximab
At a glance
Recruiting sites
21 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1
Measured over 6 months
+1 more outcome measured
Conditions
Where it's being run
21 sites across 16 statesTexas3
California2
Michigan2
Virginia2
Florida1
Maryland1
Massachusetts1
Missouri1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Received only 1 prior Tx in the metastatic setting; prior adjuvant counts as a line if progressed within 6 months
Treatment-naïve or received ≤ 1 cycle of SoC for metastatic disease
Exclusion
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
What this trial measures
- Confirmed ORR by blinded independent central review (BICR) per RESIST v1.16 months
Overall Response Rate per RECIST version 1.1, per blinded independent central review (BICR)
- To characterize the safety and tolerability of VS-7375 monotherapy or in combination with cetuximab, administered on a daily oral schedule in participants with KRAS G12D-mutated PDAC.6 months
Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, and dose interruptions/reductions and discontinuations.