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.
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.
Any systemic anti-cancer therapy for advanced BTC within 3 weeks of enrollment or 5 half-lives of the drug, whichever is shorter.
Prior treatment with any KRAS, RTK, or MEK inhibitor or other RAS-pathway targeting signal transduction inhibitor agents
Major surgery, extended field radiotherapy, or local regional therapy within 4 weeks from first dose of study drug, limited field radiotherapy within 2 weeks of first dose, or failure to recover from side effects of these prior therapies
Known additional malignancy that is progressing and requires active treatment.
Single group
Daraxonrasib
DrugDaraxonrasib will be taken at a dose of 300 mg orally once daily in 28-day cycles.
Objective Response (ORR)
ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Subjects who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders.
Overall Survival (OS)
OS is defined as the number of months from the date of treatment initiation until death from any cause or end of follow-up. OS will be censored on the date the participant was last known to be alive for participants without documentation of death at the time of analysis. Estimation based on the Kaplan-Meier curve.
Progression free survival (PFS)
PFS is defined as the number of months from the date of treatment initiation to radiographic disease progression using RECIST v1.1 criteria or death due to any cause, whichever occurs first. Progression of disease (PD) will be censored at the date of the last scan for participants without documentation of disease progression at the time of analysis. Progression will be censored at the time of treatment initiation for participants that do not have a follow up scan. Estimation based on the Kaplan-Meier curve.
Duration of response (DOR)
DOR, defined as the number of months from the date of response to the date of clinically determined disease progression or death from any cause, in participants achieving CR or PR.
Disease control rate (DCR)
DCR is defined as the proportion of participants who achieved CR, PR and stable disease (SD). Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Click on the lead sponsor to view all of their trials.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Revolution Medicines, Inc.
Collaborator
Cholangiocarcinoma Foundation
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
