VS-7375 with or without antibodies for KRAS G12D colorectal cancer

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 phase 2 trial evaluates the safety and potential effectiveness of VS-7375 as a single agent and in combination with EGFR inhibitors (cetuximab or panitumumab) or with cetuximab plus mFOLFOX6 in patients whose colorectal cancer has metastasized and carries the KRAS G12D mutation. Participants must have measurable disease, confirmed KRAS G12D status, and good performance status. The study includes both second-line or later patients as well as those who are treatment-naïve or have had limited prior therapy. Key exclusions include other common RAS mutations, recent anti-cancer therapy, major surgery, or recent radiation therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histopathology confirmed metastatic CRC
* Measurable disease per RECIST 1.1
* Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
* ECOG PS=0 or 1

  2L+ patients:
* Must have received at least 1 standard chemotherapy for metastatic colorectal adenocarcinoma
* Have documented disease progression during or following their most recent prior line of therapy
* Have either stable disease, partial response (PR), or complete response (CR) by RECIST v1.1 as the best overall response (BOR) during at least 1 prior systemic therapy.

  1L patients:
* Treatment-naïve or received no more than 1 cycle of standard systemic therapy 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
* Receipt of prior direct RAS inhibitor
* Receipt of more than 1 investigational therapy
* 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

Where it's running

• HonorHealth
  Scottsdale, Arizona, United States Recruiting
• START Los Angeles
  Los Angeles, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Valkyrie Clinical Trials (contact for more locations)
  Los Angeles, California, United States Recruiting
• BRCR - Coral Springs
  Coral Springs, Florida, United States Recruiting
• BRCR - Tamarac
  Tamarac, Florida, United States Recruiting

Study contacts

• Study coordinator: Verastem Call Center
• Email: VS-7375-203TrialSupport@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.