Back to search results

Study of Nanvuranlat for Advanced Biliary Tract Cancer

This study is testing a new treatment called Nanvuranlat for people aged 18 and older with advanced biliary tract cancer (cancer of the bile ducts). The study has two parts. Part A will help researchers choose the best dose of Nanvuranlat. Part B will compare Nanvuranlat to treatments doctors usually choose, such as FOLFOX or FOLFIRI regimens. The main goal is to see if Nanvuranlat helps people live longer. You will receive treatment every two weeks for as long as it is safe and your cancer doesn't worsen. This study is looking for 480 participants.

Study design
This is a Phase 3, multi-center, randomized, open-label study with two parts. You would be randomly assigned to receive either Nanvuranlat or a standard treatment.
What's involved
You would receive treatment every two weeks, administered on Day 1 of each cycle, for as long as it is safe and your cancer doesn't worsen.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be tracked for approximately 24 months in Part A and 36 months in Part B after your first dose of study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07265674

A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer

Recruiting
PHASE3Ages 18+InterventionalTreatment
J-Pharma Co., Ltd.
~480 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:NanvuranlatPhysician's Best Choice

At a glance

Recruiting sites
15 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Preliminary Overall Survival (OS)
Measured over From date of first dose of study intervention until death [Approx. 24 months].
+1 more outcome measured

Conditions

Advanced Biliary Tract Cancer
Biliary Tract Cancer (BTC)

Explore related trials

Extrahepatic CholangiocarcinomaGallbladder CarcinomaIntrahepatic CholangiocarcinomaMalignant neoplasm of biliary tract

NCT07265674

Where you'd take part

This study runs at 18 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope - Chicago Cancer Center (Site 128)

    Zion, Illinoisno site contact published

    Recruiting

  • City of Hope (Site 107)

    Duarte, Californiano site contact published

    Recruiting

  • Comprehensive Cancer Centers of Nevada - Central Valley (Site 124)

    Las Vegas, Nevadano site contact published

    Recruiting

  • Fred Hutchinson Cancer Center Clinic (Site 122)

    Seattle, Washingtonno site contact published

    Recruiting

  • James Cancer Hospital and Solove Research Institute (Site 119)

    Columbus, Ohiono site contact published

    Recruiting

  • Karmanos Cancer Center (Site 109)

    Detroit, Michiganno site contact published

    Recruiting

  • Masonic Cancer Center, University of Minnesota (Site 116)

    Minneapolis, Minnesotano site contact published

    Recruiting

  • Memorial Sloan Kettering Cancer Center (Site 108)

    New York, New Yorkno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Eric K Rowinsky, MD · STUDY_DIRECTOR · Uniphar Development, LLC
  • Ghassan Abou-Alfa, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Masuhiro Yoshitake
[email protected]
+81-3-6432-4270
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Abstinence from sexual activity.
Hormonal contraception (eg, injection, implant, pill, patch, or vaginal ring as available in each country) associated with inhibition of ovulation (both estrogen and progestogen and progestogen only) in use for at least 30 days before administration of study intervention.
Intrauterine device in use for at least 30 days before administration of study intervention.
Intrauterine hormone-releasing system in use for at least 30 days before administration of study intervention.
Bilateral tubal occlusion/ligation at least 6 months before administration of study intervention.
Partner who has been vasectomized at least 6 months before administration of study intervention. 17. Males and their female partners must use a highly effective method of birth control if female partner(s) is of childbearing potential, and males must not donate sperm during the study and for 9 months after the last dose of study intervention.

Exclusion

Individuals will be excluded from study participation if they meet any of the following criteria:

What this trial measures

  • Part A: Preliminary Overall Survival (OS)From date of first dose of study intervention until death [Approx. 24 months].

    OS is defined as the time from the date of Cycle 1 Day 1 to the date of death from any cause.

  • Part B: Overall SurvivalFrom date of first dose of study intervention until death [Approx. 36 months]

    OS is defined as the time from the date of Cycle 1 Day 1 to the date of death from any cause.