VS-7375 for adults with KRAS G12D-mutated advanced solid tumors.

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 1/2, multicenter, dose-escalation and expansion trial of VS-7375 given alone and in combination with several standard therapies in patients whose tumors harbor the KRAS G12D mutation. Phase 1 will define safety, tolerability, and recommended doses, while Phase 2 will explore anti-tumor activity in specific tumor cohorts such as pancreatic, colorectal, and non–small cell lung cancers. Key eligibility includes adults with measurable, advanced or metastatic disease, ECOG 0–1, and adequate organ and cardiac function. The trial is being conducted at multiple academic centers in the United States and includes endpoints for safety and objective response by RECIST v1.1.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Individuals ≥18 years of age.
* Agreement to sign and date an informed consent form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
* Histologic or cytologic evidence of locally advanced unresectable or metastatic solid tumor harboring a KRAS G12D mutation.
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate organ function
* Adequate cardiac function
* Recovered from all AEs due to previous therapies to Grade ≤1 or baseline
* Agreement to use highly effective contraception

Key Exclusion Criteria:

* Underwent major surgical procedure as defined by the Investigator, other than for diagnosis, within 4 weeks prior to Cycle 1 Day 1
* Receipt of chemotherapy, targeted therapy, or radiotherapy (excluding palliative radiation) within 4 weeks or 5 half-lives, whichever is shorter, or immunotherapy within 4 weeks prior to Cycle 1 Day 1.
* Treatment with any investigational drug at least 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1.
* History of treatment with direct RAS inhibitors.
* Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases.
* Inability to swallow oral medications.
* Evidence or history of uncontrolled, clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, coagulation, neurologic, dermatologic, autoimmune, or allergic disease.
* Individuals who are pregnant or breastfeeding.

Where it's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• Laura & Isaac Perlmutter Cancer Center at NYU Langone
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Verastem Call Center
• Email: clinicaltrials@verastem.com
• Phone: 1 781 292 4204

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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.