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.
At least 18 years of age inclusive at the time of signing the informed consent.
Provides informed written consent according to local laws or regulations.
Able and willing to comply with scheduled visits, treatment plans, procedures, and laboratory tests, including peripheral blood and urine sampling during the study.
Willing to participate in LAT1 testing and NAT2 and transporter genotyping. Note: For LAT1 testing, if the participant does not have archival tissue and a fresh biopsy is not in the best interest of the participant, they will still be eligible for the trial.
< 2 weeks prior to Cycle 1 Day 1 for systemic non-immune-based therapy
< 3 weeks prior to Cycle 1 Day 1 for immune-based therapy
≤ 5 half-lives or 3 weeks (whichever is longer) prior to Cycle 1 Day 1 for an investigational agent
Received radiotherapy to metastatic sites within 2 weeks of Cycle 1 Day 1. Patients must have recovered from all radiation-related toxicities and not require corticosteroids. A 1 week washout is permitted for palliative radiation with a limited port ≤ 2 weeks of radiotherapy to non-CNS disease.
Parallel
Nanvuranlat
DrugNanvuranlat, IV administration
Physician's Best Choice
Other intervention1. 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.
Part A: Preliminary Overall Survival (OS)
OS is defined as the time from the date of Cycle 1 Day 1 to the date of death from any cause.
Part B: Overall Survival
OS is defined as the time from the date of Cycle 1 Day 1 to the date of death from any cause.
Part B: Progression Free Survival
PFS is defined as the time from the date of Cycle 1 Day 1 to the date of objectively determined progression of disease per the Investigators using RECIST version 1.1 or death from any cause, whichever occurs first.
Part B: Objective Response Rate
ORR, defined as the proportion of patients achieving a best response of CR or PR per the Investigators using RECIST version 1.1.
Part B: Incidence of treatment-emergent adverse events (TEAEs)
Incidence of TEAEs, including serious adverse events (SAEs)
Part B: Relative Dose Intensity
Relative dose intensity is defined as the ratio of completed infusions to the total planned infusions of the study drug during the first 8 weeks of treatment.
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J-Pharma Co., Ltd.
Lead sponsor
Uniphar Development, LLC
Collaborator
