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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07265674

Public ClinicalTrials.gov record NCT07265674. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 6:22 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multicenter, Randomized, Open-label, Study Evaluating the Efficacy and Safety of Nanvuranlat in Patients With Previously Treated Advanced Biliary Tract Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study is designed to 1) select a dose regimen for continued development and 2) evaluate nanvuranlat versus Physicians Best Choice (PBC) (FOLFOX, FOLFIRI, or Best Supportive Care (BSC)) in participants aged 18 years and over with BTC. Participants enrolling in Part A the trial will be randomly assigned to receive 1 of 3 nanvuranlat dose regimens or PBC. In Part B, participants will be randomly assigned to receive nanvuranlat or PBC. Participants will receive treatment every 2 weeks for as long as they do not experience safety issues, or their cancer gets worse, and the study doctor feels they should stop treatment. Health measurements including physical examinations, vital signs, ECGs, and safety laboratory tests will be performed to monitor safety, and tumor imaging will be performed to monitor cancer response to treatment. Other exploratory makers will be measured to better understand how nanvuranlat works.

Study identification

NCT ID
NCT07265674
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
J-Pharma Co., Ltd.
Industry
Enrollment
480 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 11, 2026 (Actual)
Primary completion
Oct 2027 (Estimated)
Completion
Oct 2027 (Estimated)
Last update posted
Sep 29, 2026

2026 – 2027

United States locations

U.S. sites
18
U.S. states
14
U.S. cities
18
Facility City State ZIP Site status
City of Hope (Site 107) Duarte California 91010 Recruiting
University of California at Irvine (Site 101) Orange California 92868 Recruiting
UCLA Medical Center (Site 117) Santa Monica California 90404 Not yet recruiting
Moffitt Cancer Center Magnolia Campus (Site 123) Tampa Florida 33612 Recruiting
City of Hope - Chicago Cancer Center (Site 128) Zion Illinois 60099 Recruiting
Norton Cancer Institute (Site 115) Louisville Kentucky 40127 Recruiting
Ochsner Medical Center (Site 120) New Orleans Louisiana 70121 Recruiting
Karmanos Cancer Center (Site 109) Detroit Michigan 48201 Recruiting
Masonic Cancer Center, University of Minnesota (Site 116) Minneapolis Minnesota 55455 Recruiting
Comprehensive Cancer Centers of Nevada - Central Valley (Site 124) Las Vegas Nevada 89169 Recruiting
Rutgers Cancer Institute of New Jersey (Site 103) New Brunswick New Jersey 08901 Recruiting
Rosewell Park Comprehensive Cancer Center (Site 114) Buffalo New York 14263 Recruiting
Memorial Sloan Kettering Cancer Center (Site 108) New York New York 10065 Recruiting
University Hospitals Cleveland Medical Center Seidman Cancer Center (Site 111) Cleveland Ohio 44106 Recruiting
James Cancer Hospital and Solove Research Institute (Site 119) Columbus Ohio 43219 Recruiting
Mercy Clinic (Site 110) Oklahoma City Oklahoma 73120 Recruiting
University of Texas Southwestern Medical Center (Site 104) Dallas Texas 75390 Recruiting
Fred Hutchinson Cancer Center Clinic (Site 122) Seattle Washington 98109 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07265674, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 29, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07265674 live on ClinicalTrials.gov.

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