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

Brief description of study

Study 849-001 is a multi-center, Phase 1/2, multiple expansion cohort trial evaluating the safety, PK, metabolites, PD and clinical activity/efficacy of MRTX849 in patients with advanced solid tumor malignancies with KRAS G12C mutation. This protocol is designed as recommended in US FDA draft guidance for conduct of first-in-human multiple expansion cohort trials (FDA-2018). Oversight of this clinical trial is provided by the Sponsor, Investigators, local IRBs, a specifically commissioned Central IRB and an IDMC. Plans for communication of emerging study results are outlined in Section 9.9.3. Plans for communication of study decisions and protocol changes are outlined in Section 13.2.


Clinical Study Identifier: s19-00037
ClinicalTrials.gov Identifier: NCT03785249
Principal Investigator: Joshua K Sabari.
Other Investigators: Anam Qureshi, Elaine Shum, Scot Niglio, Vamsidhar Velcheti, Kirby Rodriguez, Janice Mehnert, Maya Dimitrova, Eneil De La Pena, Salman Rafi Punekar, Jonathan B Kahn, Keriann M Scavone, Nina Beri, Caitlin Elizabeth Ryan, David R. Wise, Abraham Chachoua, Jessica Wang, Carol M Lee, Sally Lau, Samantha VanMaanen, Kristen Spencer, Gabrielle Fridman, Nancy Chan, Douglas K Marks.


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