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

Part of paid clinical trials in Duarte, California.

Sponsor
J-Pharma Co., Ltd.
Study ID
NCT07265674
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nanvuranlat — DRUG
    Nanvuranlat, IV administration
  • Physician's Best Choice — OTHER
    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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nanvuranlat 50mg
    Nanvuranlat 50mg administered via a 90-minute intravenous infusion once daily for 5 consecutive days, followed by 9 days off treatment
  • Experimental: Navuranlat 75mg
    Nanvuranlat 75mg administered via a 90-minute intravenous infusion once daily for 5 consecutive days, followed by 9 days off treatment
  • Experimental: Navuranlat 375mg
    Nanvuranlat 375mg administered via a 46-hour continuous intravenous infusion once every 14 days
  • Other: Physicians Best Choice (PBC)
    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.

Primary Outcome Measure

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

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
City of Hope (Site 107)DuarteCalifornia91010-
University of California at Irvine (Site 101)OrangeCalifornia92868-
UCLA Medical Center (Site 117)Santa MonicaCalifornia90404-
Mount Sinai Comprehensive Cancer Center (Site 125)Miami BeachFlorida33140-
Moffitt Cancer Center Magnolia Campus (Site 123)TampaFlorida33612-
City of Hope - Chicago Cancer Center (Site 128)ZionIllinois60099-
University of Iowa Hospitals and Clinics (Site 126)Iowa CityIowa54242-
Norton Cancer Institute (Site 115)LouisvilleKentucky40127-
Ochsner Medical Center (Site 120)New OrleansLouisiana70121-
Karmanos Cancer Center (Site 109)DetroitMichigan48201-
Masonic Cancer Center, University of Minnesota (Site 116)MinneapolisMinnesota55455-
Comprehensive Cancer Centers of Nevada - Central Valley (Site 124)Las VegasNevada89169-
Rutgers Cancer Institute of New Jersey (Site 103)New BrunswickNew Jersey08901-
Rosewell Park Comprehensive Cancer Center (Site 114)BuffaloNew York14263-
Memorial Sloan Kettering Cancer Center (Site 108)New YorkNew York10065-
University Hospitals Cleveland Medical Center Seidman Cancer Center (Site 111)ClevelandOhio44106-
James Cancer Hospital and Solove Research Institute (Site 119)ColumbusOhio43219-
Mercy Clinic (Site 110)Oklahoma CityOklahoma73120-
Oregan Health and Science University (Site 127)PortlandOregon97210-
Allegheny Health Network (Site 121)PittsburghPennsylvania15212-
University of Texas Southwestern Medical Center (Site 104)DallasTexas75390-
University of Texas MD Anderson Cancer Center (Site 102)HosutonTexas77030-
Fred Hutchinson Cancer Center Clinic (Site 122)SeattleWashington98109-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAUniversity of California at Irvine· Orange, CAUCLA Medical Center· Santa Monica, CAMount Sinai Comprehensive Cancer Center· Miami Beach, FLMoffitt Cancer Center Magnolia Campus· Tampa, FLCity of Hope - Chicago Cancer Center· Zion, IL

Related Studies