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

Inclusion Criteria

• Confirmed diagnosis of pancreatic cancer.
• Cancer that can be measured using standard criteria.
• Confirmed presence of the KRAS G12D mutation in the cancer cells.
• Good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Adequate organ function as determined by medical tests.

For VS-7375 + cetuximab (second-line treatment):

• Have received only one previous treatment for metastatic cancer; if previous treatment was given after surgery and cancer returned within 6 months, it counts as one treatment.

For VS-7375 + cetuximab (first-line treatment):

• Have not received any treatment or have received one or fewer cycles of standard care for metastatic cancer.

Exclusion Criteria

• Have other common RAS mutations in addition to KRAS G12D.
• Have received any anti-cancer treatment within 4 weeks before starting the study, or within a shorter time if specified by the drug.
• Have had major surgery within 4 weeks before starting the study.
• Have had radiation therapy within 1 week before starting the study, or within 2 weeks if it was to the brain or lungs.
• Have a history of lung disease caused by drugs.
• Have previously received a direct RAS inhibitor.
• 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.