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Compares treatment options for Advanced Biliary Tract Cancer
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
ClinicalTrials.gov ID: NCT07265674
What this study is testing
What is Nanvuranlat?
Nanvuranlat is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for advanced biliary tract cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Individuals are eligible to be included in the study only if all of the following criteria apply:
- 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...
- Willing to participate in LAT1 testing and NAT2 and transporter genotyping. Note: For LAT1 testing, if the participant does not have archival tissue...
You likely can't join if
- Individuals will be excluded from study participation if they meet any of the following criteria:
- Received systemic therapy or an investigational agent before washing out, as follows:
- \< 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...
See the full eligibility criteria
Who can join
- \- Individuals are eligible to be included in the study only if all of the following criteria apply:
- 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...
- Cancer must be metastatic, locally advanced and unresectable, or not amenable to treatment with local therapies that could offer a reasonable likelihood of clinical benefit.
- Histologic or cytologic diagnosis of BTC.
- Has BTC that is classified as either an IHC, EHC, or GBC based on surgical, clinical, or laparoscopic findings and/or radiological imaging (eg, CT, MRI).
- Has received 1 prior appropriate platinum (cisplatin, carboplatin, or oxaliplatin)-based therapy for advanced disease (locally advanced or metastatic) with or without a mAb targeting PD-1 or PD-L1.
- Disease progression during or within 6 months of neoadjuvant or adjuvant treatment with a platinum-containing regimen will count as having received 1 prior regimen.
- If a patient has a mutation/fusion of IDH1, FGFR2 or NTRK, or an amplified, mutated, or overexpressed form of HER2, or a recognized aberration in a validated "driver" of BTC, and was treated with an appropriate targeted...
- ECOG PS of 0 or 1.
- Expected life expectancy of at least 90 days after the first day of treatment as per the site Investigator.
- At least 1 measurable lesion by RECIST v1.1 based on imaging (eg, CT, MRI) performed within 28 days prior to initiation of study intervention. Those who have received prior local therapy, including but not limited to...
- Resolution to ≤ Grade 1 by the NCI CTCAE v 5.0 (or higher) of all clinically significant toxic effects of prior chemotherapy or other treatments, except for alopecia and peripheral neuropathy (these must have resolved...
- Adequate hematologic function:
- ANC ≥ 1.5 × 109/L. Myeloid growth factors must not have been administered within 7 days before the participant's first dose of study intervention.
- Hemoglobin ≥ 8.5 g/dL and no RBC transfusions during the 14 days before the participant's first dose of study intervention.
- Platelet count ≥ 100 × 109/L and no platelet transfusions during the 14 days before the participant's first dose of study intervention.
- Adequate baseline organ function, as demonstrated by the following:
- eGFR ≥ 50 mL/min as estimated by CKD-EPI 2021.
- Bilirubin ≤ 2 × ULN (local institution).
- AST and ALT ≤ 5 × ULN (local institution).
- Adequate coagulation function as defined by INR ≤ 1.5 OR a PT ≤ 1.5 × ULN AND an aPTT ≤ 1.5 × ULN if not receiving anticoagulation therapy. Note: Participants may receive subtherapeutic doses of warfarin while on study...
- Women of childbearing potential must be willing to use a highly effective method of contraception throughout the study and study follow up or for at least 9 months after the last dose of study intervention. Note: A...
- Abstinence from sexual activity.
- Hormonal contraception (eg, injection, implant, pill, patch, or vaginal ring as available in each country) associated with inhibition of ovulation (both estrogen and progestogen and progestogen only) in use for at least...
- Intrauterine device in use for at least 30 days before administration of study intervention.
- Intrauterine hormone-releasing system in use for at least 30 days before administration of study intervention.
- Bilateral tubal occlusion/ligation at least 6 months before administration of study intervention.
- Partner who has been vasectomized at least 6 months before administration of study intervention.
- Males and their female partners must use a highly effective method of birth control if female partner(s) is of childbearing potential, and males must not donate sperm during the study and for 9 months after the last...
What rules you out
- Individuals will be excluded from study participation if they meet any of the following criteria:
- Received systemic therapy or an investigational agent before washing out, as follows:
- \< 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...
- Underwent hepatic radiation, chemoembolization, or radiofrequency ablation \< 4 weeks prior to Cycle 1 Day 1.
- Underwent major surgery \< 3 weeks before Screening and has not recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention.
- Known active CNS metastases and/or carcinomatous meningitis. Those with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of PD for at least 4 weeks by...
- Clinically significant cardiovascular disease (eg, uncontrolled or any New York Heart Association Class 3 or 4 heart failure, uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6...
- Resting QTcF \> 470 msec at screening.
- An additional active malignancy that is progressing or has required active treatment within the past 3 years. Cases involving a past cancer history with substantial potential for recurrence must be discussed with the...
- Require strong inhibitors of P-gp, BCRP, OATP1B1, OATP1B3, OATP1A2, and OAT3 transporters unless they can be transferred to other medications within ≥ 5 half-lives of treatment.
- Require sensitive substrates of OATP1B1 and OATP1B3 unless they can be transferred to other medications within ≥ 5 half-lives of treatment.
- Known positive status for HIV, has not been treated with established appropriate antiretroviral therapy for at least 4 weeks, and has a hydrophobic interaction chromatography viral load \< 400 copies/mL and a CD4+...
- Active or chronic HBV and active (not cured) HCV. Participants who are HBV carriers without active disease (HBV DNA titer \< 1000 copies/mL or 200 IU/mL) or cured HCV (negative HCV RNA test) with confirmed viral...
- An uncontrolled intercurrent illness including, but not limited to medical illness; uncontrolled infection requiring therapy; psychiatric illness; alcohol or drug dependence; social situations or a history or current...
- Requires therapeutic doses of warfarin (ie, requires monitoring). A washout period of 7 days before administration of a participant's first dose of study intervention is required for those in whom therapeutic doses of...
- Clinically significant edema or intracavitary fluid collections (eg, ascites, pleural effusion, pericardial effusions) resulting in moderate symptoms and/or requiring frequent drainage.
- Previously developed shock, anaphylaxis, or renal disorder due to SBECD.
- WOCBP who is pregnant, lactating, or discontinued lactation \< 12 weeks prior to Screening, or who plans to become pregnant or initiate lactation during the study.
- Known reaction or contraindication to any component of study intervention (ie, oxaliplatin, leucovorin [including levoleucovorin], and 5-FU [FOLFOX] and irinotecan, leucovorin, and 5-FU [FOLFIRI]).
- Known DPD deficiency. Screening for DPD deficiency is not mandated but should be considered in people who have had severe toxicity due to fluoropyrimidine-based therapy in the past.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Orange, California, United States
- Santa Monica, California, United States
- Tampa, Florida, United States
- Zion, Illinois, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Las Vegas, Nevada, United States
- New Brunswick, New Jersey, United States
- Buffalo, New York, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Orange, California, United States; Santa Monica, California, United States; Tampa, Florida, United States; Zion, Illinois, United States; Louisville, Kentucky, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.