VS-7375 + Cetuximab for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of a new drug, VS-7375, both alone and with other treatments, for individuals with advanced solid tumors carrying a specific KRAS G12D mutation. The trial explores multiple treatment combinations to determine the best dose. Ideal candidates have this mutation and have previously tried at least one standard treatment for their cancer, which either failed or resulted in cancer returning within six months. Participants must have non-removable tumors and cancer that has spread. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications, but you cannot have had chemotherapy, targeted therapy, or radiotherapy within 4 weeks before starting the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that VS-7375 appears safe for treating advanced solid tumors with the KRAS G12D mutation. Studies indicate that people generally tolerate this treatment well. Early results suggest it could be a safe option for managing these tumors.
When combined with cetuximab, VS-7375 has also demonstrated promising safety and tolerability. This combination is under close study, and initial findings are positive, indicating it may not cause significant side effects.
These treatments are currently in early clinical trials, which are the initial phase of testing for safety and effectiveness. While this stage focuses mainly on safety, long-term effects are still under investigation. However, early data on VS-7375, both alone and with cetuximab, is promising in terms of safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatments involving VS-7375 because they offer a novel approach to targeting solid tumors with a KRAS G12D mutation. Unlike standard treatments that might not specifically target this mutation, VS-7375 works by directly interacting with the KRAS protein, potentially disrupting its role in cancer cell growth. Additionally, combining VS-7375 with established chemotherapy drugs like carboplatin and gemcitabine, as well as targeted therapies like cetuximab, could enhance the treatment's effectiveness and offer new hope for patients with limited options. This targeted approach may lead to more effective treatments with potentially fewer side effects compared to broad-spectrum chemotherapy.
What evidence suggests that this trial's treatments could be effective for advanced solid tumors with a KRAS G12D mutation?
Research has shown that VS-7375 may help treat advanced solid tumors with a specific change in the KRAS gene, known as G12D. In one study, 80% of evaluable patients experienced tumor shrinkage. Another report found that 41% of patients with heavily treated pancreatic cancer saw their tumors shrink or disappear after treatment. In this trial, some participants will receive VS-7375 in combination with cetuximab to explore its efficacy further. Overall, early data suggest that VS-7375 could be a promising treatment for tumors with the KRAS G12D mutation.13678
Are You a Good Fit for This Trial?
Adults with advanced solid tumors that have a specific KRAS G12D mutation can join this trial. They must have tried at least one standard treatment or had their cancer return within 6 months after initial therapy. Good heart and organ function are required, as well as an agreement to use effective birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
To determine the recommended phase 2 dose (RP2D) for VS-7375 and cetuximab + VS-7375 in patients with advanced solid tumors harboring a KRAS G12D mutation
Dose Expansion
To determine the efficacy of VS-7375 and cetuximab + VS-7375 at the recommended phase 2 dose (RP2D) in patients with advanced KRAS G12D-mutated solid tumors
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VS-7375
Find a Clinic Near You
Who Is Running the Clinical Trial?
Verastem, Inc.
Lead Sponsor