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Phase 2 Study of Daraxonrasib in Recurrent KRAS-Mutant Biliary Tract Cancer

NCT07793253 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Biliary Tract Cancers
  • Intrahepatic Cholangiocarcinoma (Icc)
  • Extrahepatic Cholangiocarcinoma
  • Gallbladder Carcinoma
  • Ampulla of Vater Carcinoma
  • Ampullary Carcinoma

Interventions

DRUG

Daraxonrasib

Daraxonrasib will be taken at a dose of 300 mg orally once daily in 28-day cycles.

Sponsors & Collaborators

  • Revolution Medicines, Inc.

    collaborator INDUSTRY

  • Cholangiocarcinoma Foundation

    collaborator UNKNOWN

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Nilo Azad, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2030-11-30
Completion
2030-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07793253 on ClinicalTrials.gov