Actively Recruiting
Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)
Led by Nataliya Uboha · Updated on 2026-01-23
33
Participants Needed
4
Research Sites
172 weeks
Total Duration
On this page
Sponsors
N
Nataliya Uboha
Lead Sponsor
A
Arcus Biosciences, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed biliary tract cancer by AJCC version 8.
- Locally advanced, recurrent, or metastatic biliary tract cancer without prior systemic treatment for advanced disease.
- Prior adjuvant therapy allowed if recurrence occurred 6 months or more after completion.
- Age 18 years or older at consent.
- ECOG Performance Status of 0 to 2 within 28 days before enrollment.
- Presence of measurable or evaluable disease per RECIST v1.1.
- Adequate organ function as specified in the study protocol.
- Negative pregnancy test within 14 days before enrollment for females of childbearing potential.
- Willingness to use effective contraception or abstain from heterosexual vaginal intercourse during the study and for specified periods after treatment.
- Ability to understand and follow study procedures for the entire study duration.
You will not qualify if you...
- Previous treatment with gemcitabine, cisplatin, or immune checkpoint inhibitors for biliary tract cancer.
- Known allergy to recombinant proteins or any ingredients in study medications.
- Active autoimmune disease requiring systemic treatment in the past 2 years (excluding replacement therapies).
- History of solid organ or bone marrow transplantation.
- Pregnant or breastfeeding women.
- Prior or concurrent cancers that could interfere with study assessments.
- Untreated central nervous system metastases.
- Medical conditions making treatment unsafe, including interstitial lung disease or recent serious infections.
- Major trauma or surgery within 28 days before first treatment dose.
- Palliative radiation therapy within 14 days before starting treatment.
- Psychiatric or substance abuse disorders interfering with trial participation.
- Significant mental conditions preventing informed consent.
- Live vaccines given within 4 weeks before starting study treatments.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
4
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
N
Nataliya Uboha, MD, PhD
CONTACT
L
LeaEtta Hyer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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