Study on VS-7375 for Patients with KRAS G12D-Mutated Solid Tumors

Inclusion Criteria

• Must be 18 years or older.
• Agree to sign a consent form to participate in the study.
• Have a confirmed diagnosis of an advanced solid tumor with a KRAS G12D mutation that cannot be surgically removed or has spread to other parts of the body.
• Have received at least one previous treatment for advanced cancer or had cancer return within 6 months after initial treatment.
• Have measurable cancer that can be tracked using standard criteria.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have good organ and heart function as determined by medical tests.
• Have recovered from any side effects of previous treatments to a mild level or back to normal.
• Agree to use effective birth control methods during the study.

Exclusion Criteria

• Have had major surgery, other than for diagnosis, within 4 weeks before starting the study treatment.
• Have received chemotherapy, targeted therapy, or radiation therapy (except for palliative care) within 4 weeks or 5 half-lives of the drug, whichever is shorter, before starting the study treatment.
• Have taken any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before starting the study treatment.
• Have previously been treated with drugs that specifically target the KRAS G12D mutation.
• Have untreated or worsening cancer that has spread to the brain or central nervous system.
• Cannot swallow pills or capsules.
• Have uncontrolled or significant medical conditions affecting blood, kidneys, liver, hormones, lungs, stomach, heart, mental health, blood clotting, nerves, skin, immune system, or allergies.
• Are pregnant or breastfeeding.