RecruitingPhase 3NCT07265674

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

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

Sponsor

J-Pharma Co., Ltd.

Enrollment

480 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Biliary Tract Cancer (BTC)Advanced Biliary Tract Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral drug called nanvuranlat for people with advanced biliary tract cancer (cancer of the bile ducts or gallbladder) that has already been treated with at least one round of platinum-based chemotherapy. Part A selects the best dose; Part B tests whether the drug improves survival compared to doctors' best available treatment. **You may be eligible if...** - You are 18 or older - You have confirmed biliary tract cancer (bile duct or gallbladder) that has spread or cannot be surgically removed - You have already received at least one round of platinum-based chemotherapy (with or without immunotherapy) for advanced disease - Your cancer is progressing or has not responded to your last treatment - You are in good enough health to carry out light daily activities - Your life expectancy is at least 90 days - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have active cancer spread to the brain - You have significant heart problems (recent heart attack, stroke, or uncontrolled heart failure) - You have active HIV, hepatitis B, or hepatitis C - You are pregnant or breastfeeding - You have significant fluid build-up in your abdomen or chest causing symptoms - You are receiving certain medications that strongly interact with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNanvuranlat

Nanvuranlat, IV administration

OTHERPhysician's Best Choice

1. FOLFOX regimen (Leucovorin, 5-Flurouracil and Oxaliplatin) administered on Day 1 of each 14 day cycle, or 2. FOLFIRI regimen (Leucovorin, 5-Flurouracil and Irinotecan) administered once during 14 day cycle, or 3. Best Supportive Care (BSC) including symptomatic therapeutics, palliative radiation for pre-existing metastases and transfusion of blood products administered at discretion of Investigator.

Locations(18)

Banner MD Anderson Cancer Center (Site 106)

Gilbert, Arizona, United States

City of Hope (Site 107)

Duarte, California, United States

University of California at Irvine (Site 101)

Orange, California, United States

UCLA Medical Center (Site 117)

Santa Monica, California, United States

Norton Cancer Institute (Site 115)

Louisville, Kentucky, United States

Ochsner Medical Center (Site 120)

New Orleans, Louisiana, United States

Henry Ford Cancer Center (Site 113)

Detroit, Michigan, United States

Karmanos Cancer Center (Site 109)

Detroit, Michigan, United States

Masonic Cancer Center, University of Minnesota (Site 116)

Minneapolis, Minnesota, United States

Rutgers Cancer Institute of New Jersey (Site 103)

New Brunswick, New Jersey, United States

Rosewell Park Comprehensive Cancer Center (Site 114)

Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center (Site 108)

New York, New York, United States

University Hospitals Cleveland Medical Center Seidman Cancer Center (Site 111)

Cleveland, Ohio, United States

James Cancer Hospital and Solove Research Institute (Site 119)

Columbus, Ohio, United States

Mercy Clinic (Site 110)

Oklahoma City, Oklahoma, United States

Allegheny Health Network (Site 121)

Pittsburgh, Pennsylvania, United States

University of Texas Southwestern Medical Center (Site 104)

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center (Site 102)

Hosuton, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07265674

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