Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)
NCT ID: NCT06048133
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
33 participants
INTERVENTIONAL
2024-03-08
2027-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A
Quemliclustat (AB680), zimberelimab (AB122), gemcitabine, and cisplatin in subjects with untreated advanced BTC. Quemliclustat IV: Day 1, 15, and 29 of each cycle; Zimberelimab IV: Day 1 and 22 of each cycle; Gemcitabine IV: Day 1, 8, 22 and 29 of each cycle; Cisplatin IV: Day 1, 8, 22 and 29 of Cycles 1-4 only.
Gemcitabine
Gemcitabine IV: Day 1, 8, 22, and 29 every 42 days
Cisplatin
Cisplatin IV: Day 1, 8, 22, and 29 every 42 days of Cycles 1-4 only.
Zimberelimab
Zimberelimab IV: Day 1 and 22 every 42 days
Quemliclustat
Quemliclustat IV: Day 1, 15, 29 every 42 days
Interventions
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Gemcitabine
Gemcitabine IV: Day 1, 8, 22, and 29 every 42 days
Cisplatin
Cisplatin IV: Day 1, 8, 22, and 29 every 42 days of Cycles 1-4 only.
Zimberelimab
Zimberelimab IV: Day 1 and 22 every 42 days
Quemliclustat
Quemliclustat IV: Day 1, 15, 29 every 42 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
6. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial.
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.
9. History of trauma or major surgery within 28 days prior to the first dose of IP. (Note that placement of central venous access catheter (e.g., port or similar) is not considered a major surgical procedure.
10. Treatment with palliative radiation therapy within 14 days of study treatment initiation.
11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
12. Significant dementia or other mental condition that precludes the participant's ability to consent to the study.
13. Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational products.
18 Years
ALL
No
Sponsors
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Arcus Biosciences, Inc.
INDUSTRY
Gilead Sciences
INDUSTRY
University of Wisconsin, Madison
OTHER
Nataliya Uboha
OTHER
Responsible Party
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Nataliya Uboha
Sponsor Investigator
Principal Investigators
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Nataliya Uboha, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BTCRC-GI22-564
Identifier Type: -
Identifier Source: org_study_id
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