Wu Xi, China

A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy (KRYSTAL-10)

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation

* Phase 1 dose escalation of MRTX849 to determine maximum tolerated dose. * Phase 1b expansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 to recommend Phase 2 regimens. * Separate Phase 2 cohorts of patients stratified by histological diagnosis for evaluation of clinical activity of MRTX849. * MRTX849 will be administered orally in a continuous regimen. The **Pilot Phase 1b Combination with Pembrolizumab** arm of the study will evaluate the safety, tolerability, PK, and clinical activity of the investigational study agent, MRTX849, in combination with pembrolizumab in patients with NSCLC. The **Pilot Phase 1b Combination with Cetuximab** arm of the study will evaluate the safety, tolerability, PK, and clinical activity of MRTX849 in combination with cetuximab in patients with CRC. Lastly, the **Pilot Phase 1b Combination with Afatinib** arm of the study will evaluate the safety, tolerability, PK and clinical activity of MRTX849 in combination with afatinib in patients with NSCLC.

Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET

MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic changes of the MET gene (mutation or amplification [increase number of gene copies]). Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have previously received treatment with chemotherapy. The number of patients to be enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265 will be administered orally, twice daily. The study is designed to evaluate whether the number of patients experiencing tumor size reduction is substantially higher than would be expected with other available treatments