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RECRUITINGPHASE2

Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)

Study of Gemcitabine, Cisplatin, Quemliclustat (AB680) and Zimberelimab (AB122) During First-line Treatment of Advanced Biliary Tract Cancers (QUIC)

NCT06048133•Nataliya Uboha

View on ClinicalTrials.gov

Summary

This is a phase 2 study of gemcitabine, cisplatin, zimberelimab (AB122) and quemliclustat (AB680) in subjects with untreated advanced biliary tract cancers (BTC). The study will include a safety run-in involving 6 study participants. The goal of the safety run-in is to screen for early safety signals of the proposed drug combination. Trial enrollment can continue while full safety assessment is being completed for the first 6 subjects. Participants will receive 4 cycles of combination therapy as described. After 4 cycles (\~6 months), cisplatin will be discontinued, while gemcitabine, zimberelimab (AB122), and quemliclustat (AB680) will be continued. Subjects will be treated until disease progression or development of intolerable toxicities. In total, there will be up to 39 participants on the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with cytologically or histologically confirmed BTC by AJCC version 8.
•2. Patients must have late stage (locally advanced, recurrent or metastatic) BTC. Patients must not have received systemic treatment for advanced disease. Prior adjuvant therapy is allowed as long as recurrences occurred 6 months or later from all treatment completion.
•3. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
•4. Age ≥ 18 years at the time of consent.
•5. ECOG Performance Status of 0-2 within 28 days prior to registration.
•6. Presence of measurable or evaluable disease, as defined by RECIST v1.1.
•7. Adequate organ function as detailed in the protocol.
•8. Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 14 days prior to registration. NOTE: Biliary cancer may secrete hormones to produce a false-positive pregnancy test. Female subjects of childbearing potential with a positive pregnancy test should have a thorough history and additional work up as determined by the treating physician to rule out pregnancy (e.g. serial βHCG measurements, ultrasound). Once pregnancy has been ruled out, the subject may proceed with screening and enrollment.
•9. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study and for up to 14 months after the last dose of study drug(s). Males able to father a child must be willing to abstain from heterosexual vaginal intercourse or to use an effective method(s) of contraception from initiation of treatment, during the study and for up to 11 months after the last dose of study drug(s). See the protocol for specific timeframes for each drug.
•10. Ability of the subject to understand and comply with study procedures for the entire length of the study, as determined by the enrolling physician or protocol designee.

Exclusion Criteria

•1. Prior therapy with gemcitabine, cisplatin, or any immune checkpoint inhibitors for the treatment of BTC.
•2. Known hypersensitivity to recombinant proteins, or any excipient contained in treatment medication formulations.
•3. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
•NOTE: participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study.
•4. History of solid organ or allogeneic bone marrow transplantation.
•5. Pregnant or breastfeeding. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.
•7. Untreated central nervous system (CNS) metastasis. Screening of asymptomatic patients for CNS metastasis is not required for enrollment.
•8. Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of IP(s) hazardous, including but not limited to
•* Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis.
•* Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of the study treatments.
+5 more criteria

Locations (4)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

University of Wisconsin

Madison, Wisconsin, United States

Key Dates

Start Date

March 8, 2024

Primary Completion Date

January 1, 2026

Completion Date

July 1, 2027

Last Updated

January 23, 2026

Enrollment

ESTIMATED participants

Conditions

Biliary Tract CarcinomaCholangiocarcinomaBile Duct Cancer

Interventions

Gemcitabine

DRUG

Cisplatin

DRUG

Zimberelimab

DRUG

Quemliclustat

DRUG

Contacts

Nataliya Uboha, MD, PhD

CONTACT

608-265-9966 nvuboha@medicine.wisc.edu

LeaEtta Hyer

CONTACT

317-634-5842 lhyer@hoosiercancer.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)

Inclusion Criteria

Exclusion Criteria

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