A Phase 1/2a Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors

Launched by VERASTEM, INC. · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called VS-7375 for patients with certain types of advanced solid tumors that have a specific genetic change known as the KRAS G12D mutation. The goal is to see how safe the treatment is and how well it works, both on its own and when combined with other therapies. This trial is open to adults aged 18 and older who have already tried at least one other treatment for their cancer and have measurable disease. Participants will need to sign an agreement to join the study and meet specific health criteria to ensure their safety.

If you or someone you know is interested in this trial, it's important to know that participants will undergo regular check-ups and monitoring during the study to assess their health and how well the treatment is working. The trial is not yet recruiting participants, so it may take some time before it starts. Those who are pregnant, breastfeeding, or have certain health conditions may not be eligible to participate. Overall, this study could provide new hope for patients with these challenging types of cancer.

Gender

ALL

Eligibility criteria

• 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.
• • Must have received ≥1 prior line of standard systemic therapy for advanced or metastatic disease or experienced cancer progression within 6 months of neoadjuvant or adjuvant therapy.
• • 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 and specific KRAS G12D 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.