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Daraxonrasib for Biliary Tract Cancer

NA
Overseen ByNilo Azad, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

NA

Nilo Azad, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults with advanced or inoperable biliary tract cancer (including bile duct, gallbladder, and related cancers) that has a KRAS mutation. Participants must have already tried standard treatment without success or couldn't tolerate it.

Inclusion Criteria

Willingness to provide serial tissue and blood samples for mandatory translational research
Evidence of post-menopausal status or a negative pregnancy test in women of childbearing potential (WOCBP)
Agreement to use acceptable form of birth control while on study
See 9 more

Exclusion Criteria

I have serious heart or blood vessel disease.
I have not had systemic treatment for advanced bile duct cancer in the last 3 weeks.
Known psychiatric or substance use disorder that would interfere with cooperation with the requirements of the trial
See 16 more

What Are the Treatments Tested in This Trial?

Interventions

  • Daraxonrasib

Trial Overview

The study tests daraxonrasib as a single drug to see if it can shrink tumors in people with KRAS-mutant biliary tract cancer who have few other options. All participants receive the same treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DaraxonrasibExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials
578
Recruited
33,600+

Cholangiocarcinoma Foundation

Collaborator

Revolution Medicines, Inc.

Industry Sponsor

Trials
14
Recruited
4,500+

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