Trial NCT07644559
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
- Phase
- Phase 2
- Sponsor
- Verastem, Inc.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC); G12D Mutated KRAS
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* 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 1Performance status
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 criteria:
* Have any documented co-existing pathogenic or likely pathogenic RAS mutation(s) in KRAS
* 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 metastasisBrain metastases
* 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, P-CABs, or H2 blocker within 5 days
* Inability to swallow oral medication
* Other protocol-defined inclusion/exclusion criteria may apply
Restrictions found (2)
- Brain metastasesConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG PS 0 or 1
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County
- Dana-Farber Cancer Institute · Boston, Suffolk County