TriangleThe film gives the main points. The full list below is copied from the registry; the study team makes the final decision.
- Age18 Years to no maximum
- SexAll
- Healthy volunteersNo
You may be able to join if
- 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
You cannot join if
- 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 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, P-CABs, or H2 blocker within 5 days
- Inability to swallow oral medication
- Other protocol-defined inclusion/exclusion criteria may apply