SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation
Sponsored by Navire Pharma Inc., a BridgeBio company
About this trial
Last updated a year ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 2 years ago
What is this trial about?
What are the Participation Requirements?
Key Inclusion Criteria: * Patients must have histologically documented, locally advanced and unresectable, or metastatic solid tumor with documentation of a KRAS-G12C mutation within 2 years prior to screening. * Patients must have measurable disease by RECIST v1.1. * Patients must have a minimum life expectancy of >12 weeks after start of study treatment. * Patients must have progression or disease recurrence on or after all available standard of care therapies. * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * Patients must have adequate organ function. Key Exclusion Criteria: * Patients that have participated in an interventional clinical study within the last 4 weeks. * Patients that have received radiotherapy or proton therapy with a limited field of radiation for palliation within 1 week of the start of study treatment, OR radiation to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the start of study treatment. * Patients with untreated and/or active CNS metastases. * Patients that have a history of allogenic bone marrow transplant.
