A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer

Inclusion criteria

• Histopathology confirmed metastatic CRC
• Measurable disease per RECIST 1.1
• Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
• ECOG PS=0 or 1
• L+ patients:
• Must have received at least 1 standard chemotherapy for metastatic colorectal adenocarcinoma
• Have documented disease progression during or following their most recent prior line of therapy
• Have either stable disease, partial response (PR), or complete response (CR) by RECIST v1.1 as the best overall response (BOR) during at least 1 prior systemic therapy.
• L patients:
• Treatment-naïve or received no more than 1 cycle of standard systemic therapy for metastatic disease.

Exclusion criteria

• Have any other documented co-existing common RAS mutation(s)
• Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter
• Major surgery within 4 weeks of first treatment dose
• Radiation therapy (RT) within 1 week of first treatment dose
• Receipt of prior direct RAS inhibitor
• Receipt of more than 1 investigational therapy
• Untreated or symptomatic CNS metastasis
• Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter
• Receipt of PPI or H2 blocker within 5 days
• Inability to swallow oral medication
• Other protocol-defined inclusion/exclusion criteria may apply