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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: J-Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 3, multicenter, randomized, open-label, 2-part study designed to select a dose regimen for continued development (Part A) and evaluate the efficacy and safety of nanvuranlat versus PBC (Part B) for the treatment of patients with advanced (locally advanced or metastatic) BTC who have previously received 1 prior standard therapy for advanced BTC plus appropriate therapies targeting druggable molecular mutations/aberrations. Randomization will be stratified by disease subtypes: IHC, EHC, and GBC. Part A (Dose Regimen Selection) - Three nanvuranlat dose regimens will be evaluated in Part A. Cohorts 1 and 2 will receive 50 or 75 mg of nanvuranlat via a 90-minute infusion, once daily for 5 days, followed by 9 days treatment free (Nanvuranlat-5/9). Cohort 3 will receive 375 mg of nanvuranlat via a 46-hour infusion once every 14 days (Nanvuranlat-46). Participants will be randomized 1:1:1:1 to 4 cohorts. Each treatment cycle will be 14 days and study intervention will be administered beginning on Day 1 during each treatment cycle, except for those participants receiving BSC who will receive care at the discretion of the Investigator. Part B (Efficacy Evaluation) - Participants will be randomized 1:1 to either nanvuranlat (dose regimen selected in Part A) or PBC (FOLFOX, FOLFIRI, or BSC). Each treatment cycle will be 14 days and study intervention will be administered beginning on Day 1 during each treatment cycle, except for those participants receiving BSC who will receive care at the discretion of the Investigator.

Conditions

• Advanced Biliary Tract Cancer
• Biliary Tract Cancer (BTC)

Interventions

Type	Name	Description
DRUG	Nanvuranlat	Nanvuranlat, IV administration
OTHER	Physician'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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2025-12-05
• Last updated: 2026-04-09

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study