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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT07793253
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Nov 30, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2030
Completion
Nov 30, 2030

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Daraxonrasib

Primary Outcome Measure

Objective Response (ORR) [ Time Frame: 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-

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By research site
Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

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