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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 criteria:
* 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
* Other protocol-defined inclusion/exclusion criteria may apply
Primary outcome measure(s)
Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1 — 6 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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