Actively Recruiting
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
Led by J-Pharma Co., Ltd. · Updated on 2026-05-14
480
Participants Needed
23
Research Sites
78 weeks
Total Duration
On this page
Sponsors
J
J-Pharma Co., Ltd.
Lead Sponsor
U
Uniphar Development, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at the time of signing consent
- Provide informed written consent
- Able and willing to follow scheduled visits, treatments, procedures, and laboratory tests including blood and urine samples
- Willing to participate in LAT1 testing and genotyping for NAT2 and transporters
- Have metastatic, locally advanced unresectable BTC or disease not suitable for local therapies
- Histologic or cytologic diagnosis of biliary tract cancer
- BTC classified as intrahepatic, extrahepatic, or gallbladder cancer
- Received one prior platinum-based therapy for advanced disease, with or without PD-1/PD-L1 targeted therapy
- ECOG performance status of 0 or 1
- Expected life expectancy of at least 90 days after first treatment
- At least one measurable lesion by RECIST v1.1 within 28 days before starting study intervention
- Resolution of prior treatment toxic effects to Grade 1 or less (except alopecia and neuropathy which can be Grade 2)
- Adequate blood counts: ANC ≥ 1.5 x 10^9/L, hemoglobin ≥ 8.5 g/dL, platelet count ≥ 100 x 10^9/L
- Adequate organ function: eGFR ≥ 50 mL/min, bilirubin ≤ 2 x upper limit of normal, AST and ALT ≤ 5 x upper limit of normal
- Adequate coagulation function (INR ≤ 1.5 or PT and aPTT ≤ 1.5 x upper limit of normal if not on anticoagulants)
- Women of childbearing potential must use effective contraception during the study and for 9 months after last dose
- Males and female partners must use effective contraception during the study and for 9 months after last dose
You will not qualify if you...
- Received systemic therapy or investigational agent less than 2 weeks (non-immune therapy), 3 weeks (immune therapy), or ≤ 5 half-lives prior to first study dose
- Radiotherapy to metastatic sites within 2 weeks prior to first dose, unless recovered and not requiring corticosteroids
- Hepatic radiation, chemoembolization, or radiofrequency ablation less than 4 weeks prior to first dose
- Major surgery less than 3 weeks before screening without adequate recovery
- Active CNS metastases or carcinomatous meningitis, except stable treated brain metastases without recent corticosteroids
- Clinically significant cardiovascular disease or uncontrolled conditions
- Resting QTcF > 470 msec at screening
- Additional active malignancy progressing or requiring treatment within past 3 years, with some exceptions
- Use of strong inhibitors or sensitive substrates of certain drug transporters unless switched before treatment
- Untreated or uncontrolled HIV, active hepatitis B or C, or uncontrolled infections
- Uncontrolled illnesses including psychiatric, substance dependence, or social situations interfering with participation
- Require therapeutic doses of warfarin (low doses for catheter patency allowed)
- Significant edema or fluid collections causing symptoms or frequent drainage
- Previous severe reactions to study drug components
- Women who are pregnant, lactating, or planning pregnancy during the study
- Known reactions or contraindications to chemotherapy components (oxaliplatin, leucovorin, 5-FU, irinotecan)
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
AI-Screening
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Trial Site Locations
Total: 23 locations
1
City of Hope (Site 107)
Duarte, California, United States, 91010
Actively Recruiting
2
University of California at Irvine (Site 101)
Orange, California, United States, 92868
Actively Recruiting
3
UCLA Medical Center (Site 117)
Santa Monica, California, United States, 90404
Not Yet Recruiting
4
Mount Sinai Comprehensive Cancer Center (Site 125)
Miami Beach, Florida, United States, 33140
Not Yet Recruiting
5
Moffitt Cancer Center Magnolia Campus (Site 123)
Tampa, Florida, United States, 33612
Not Yet Recruiting
6
City of Hope - Chicago Cancer Center (Site 128)
Zion, Illinois, United States, 60099
Actively Recruiting
7
University of Iowa Hospitals and Clinics (Site 126)
Iowa City, Iowa, United States, 54242
Not Yet Recruiting
8
Norton Cancer Institute (Site 115)
Louisville, Kentucky, United States, 40127
Not Yet Recruiting
9
Ochsner Medical Center (Site 120)
New Orleans, Louisiana, United States, 70121
Not Yet Recruiting
10
Karmanos Cancer Center (Site 109)
Detroit, Michigan, United States, 48201
Not Yet Recruiting
11
Masonic Cancer Center, University of Minnesota (Site 116)
Minneapolis, Minnesota, United States, 55455
Not Yet Recruiting
12
Comprehensive Cancer Centers of Nevada - Central Valley (Site 124)
Las Vegas, Nevada, United States, 89169
Actively Recruiting
13
Rutgers Cancer Institute of New Jersey (Site 103)
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
14
Rosewell Park Comprehensive Cancer Center (Site 114)
Buffalo, New York, United States, 14263
Not Yet Recruiting
15
Memorial Sloan Kettering Cancer Center (Site 108)
New York, New York, United States, 10065
Not Yet Recruiting
16
University Hospitals Cleveland Medical Center Seidman Cancer Center (Site 111)
Cleveland, Ohio, United States, 44106
Actively Recruiting
17
James Cancer Hospital and Solove Research Institute (Site 119)
Columbus, Ohio, United States, 43219
Not Yet Recruiting
18
Mercy Clinic (Site 110)
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
19
Oregan Health and Science University (Site 127)
Portland, Oregon, United States, 97210
Not Yet Recruiting
20
Allegheny Health Network (Site 121)
Pittsburgh, Pennsylvania, United States, 15212
Not Yet Recruiting
21
University of Texas Southwestern Medical Center (Site 104)
Dallas, Texas, United States, 75390
Actively Recruiting
22
University of Texas MD Anderson Cancer Center (Site 102)
Hosuton, Texas, United States, 77030
Not Yet Recruiting
23
Fred Hutchinson Cancer Center Clinic (Site 122)
Seattle, Washington, United States, 98109
Not Yet Recruiting
Research Team
M
Masuhiro Yoshitake
CONTACT
K
Kazuo Sekiguchi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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