KRAS G12D-mutated pancreatic cancer: VS-7375 with or without cetuximab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial evaluating the safety and activity of VS-7375 as a single agent and in combination with cetuximab in patients with metastatic pancreatic ductal adenocarcinoma carrying the KRAS G12D mutation. Eligible participants have confirmed PDAC with measurable disease and a KRAS G12D mutation, good performance status, and adequate organ function. Cohorts include patients who have progressed after prior therapy and treatment-naïve or minimally treated patients in the metastatic setting. Exclusion criteria include other pathogenic KRAS mutations, recent anti-cancer treatment, recent major surgery or radiation, and history of drug-induced interstitial lung disease.

Why it matters

Who can join: the full rules

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 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 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

Where it's running

• START- Los Angeles
  Los Angeles, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Valkyrie Clinical Trials
  Los Angeles, California, United States Recruiting
• BRCR Global- Coral Springs
  Coral Springs, Florida, United States Recruiting
• Mayo Clinical Florida
  Jacksonville, Florida, United States Recruiting
• BRCR Global- Tamarac
  Tamarac, Florida, United States Recruiting

Study contacts

• Study coordinator: Verastem Call Center
• Email: VS-7375-201TrialSupport@verastem.com
• Phone: 7812924204

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.