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RECRUITING Phase 3

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

NCT07265674 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Nanvuranlat
  • OTHER Physician's Best Choice

Study Locations (18)

California

  • City of Hope (Site 107) — Duarte
  • University of California at Irvine (Site 101) — Orange
  • UCLA Medical Center (Site 117) — Santa Monica

Michigan

  • Henry Ford Cancer Center (Site 113) — Detroit
  • Karmanos Cancer Center (Site 109) — Detroit

New York

  • Rosewell Park Comprehensive Cancer Center (Site 114) — Buffalo
  • Memorial Sloan Kettering Cancer Center (Site 108) — New York

Ohio

  • University Hospitals Cleveland Medical Center Seidman Cancer Center (Site 111) — Cleveland
  • James Cancer Hospital and Solove Research Institute (Site 119) — Columbus

Texas

  • University of Texas Southwestern Medical Center (Site 104) — Dallas
  • University of Texas MD Anderson Cancer Center (Site 102) — Hosuton

Arizona

  • Banner MD Anderson Cancer Center (Site 106) — Gilbert

Kentucky

  • Norton Cancer Institute (Site 115) — Louisville

Louisiana

  • Ochsner Medical Center (Site 120) — New Orleans

Trial Details

FieldValue
Enrollment Target 480 participants
Start Date 2026-01
Est. Completion 2027-10
Phase Phase 3

Sponsor

J-Pharma Co.

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07265674

The ClinicalTrials.gov registry entry for NCT07265674 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is J-Pharma Co., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Biliary Tract Cancer (BTC) appearing as the primary indexed condition, and to 2 interventions — of which Nanvuranlat is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07265674 reports 18 study locations spanning 12 distinct geographic areas — top geographies include California, Michigan, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07265674 about?

NCT07265674 is a clinical study titled "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". 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 a...

What is the current status of trial NCT07265674?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 480 participants. The study started on 2026-01. Estimated completion is 2027-10.

What conditions does trial NCT07265674 study?

This clinical trial studies the following conditions: Biliary Tract Cancer (BTC), Advanced Biliary Tract Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07265674?

The interventions under investigation include: Nanvuranlat (DRUG), Physician's Best Choice (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07265674?

This trial is sponsored by J-Pharma Co., which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07265674 being conducted?

This trial has 18 study locations across Arizona, California, Kentucky, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial