Phase 2 Study of VS-7375 for Patients with KRAS G12D-Mutated Colorectal Cancer

Inclusion Criteria

• Have advanced colorectal cancer confirmed by lab tests.

• Have cancer that can be measured using standard criteria.

• Have a confirmed KRAS G12D mutation in the cancer cells.

• Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

  For patients who have had previous treatments:

• Must have received at least one standard chemotherapy treatment for advanced colorectal cancer.

• Have cancer that has progressed during or after the last treatment.

• Have had stable disease or some level of response to at least one previous treatment.

  For patients who are new to treatment:

• Have not received treatment or have had no more than one cycle of standard treatment for advanced cancer.

Exclusion Criteria

• Have other common RAS mutations in addition to KRAS G12D.
• Have had any cancer treatment within four weeks before starting the study, or within a shorter time if specified by the drug guidelines.
• Have had major surgery within four weeks before starting the study.
• Have had radiation therapy within one week before starting the study.
• Have previously received a direct RAS inhibitor.
• Have received more than one experimental treatment.
• Have untreated or symptomatic cancer that has spread to the brain.
• Are taking certain medications that affect liver enzymes or stomach acid within a specified time before starting the study.
• Cannot swallow pills.
• Other specific criteria may apply as defined by the study protocol.