Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
The purpose of this study is to evaluate the anti-tumor efficacy of daraxonrasib monotherapy in patients with unresectable or advanced/metastatic, KRAS-mutant BTC who have progressed on or are intolerant of 1st line systemic therapy.
Inclusion Criteria: * Unresectable locally advanced or metastatic histologically or cytologically confirmed biliary tract cancer * Must have documented disease progression or intolerance of one prior systemic chemotherapy regimen (with or without immunotherapy) for unresectable and/or advanced stage disease. * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1. * Have measurable disease based on RECIST 1.1. * Documented KRAS mutation * Adequate organ and marrow function defined by study-specified laboratory tests and procedures. * Willingness to provide serial…
Daraxonrasib will be taken at a dose of 300 mg orally once daily in 28-day cycles.
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