Clinical Research Directory

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 2L+ 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. 1L 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