Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNataliya Uboha
About this trial
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 criteria
Qualifiers
Patients with cytologically or histologically confirmed BTC by AJCC version 8.
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.
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.
Age ≥ 18 years at the time of consent.
Disqualifiers
Prior therapy with gemcitabine, cisplatin, or any immune checkpoint inhibitors for the treatment of BTC.
Known hypersensitivity to recombinant proteins, or any excipient contained in treatment medication formulations.
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.
History of solid organ or allogeneic bone marrow transplantation.
Trial design
Treatments tested in this trial
- Gemcitabine
- Cisplatin
- Zimberelimab
- Quemliclustat
Treatment groups
33 Participants
are divided into 1 treatment groupLocations
4Indiana University Melvin and Bren Simon Comprehensive Cancer Center46202, IndianapolisIndiana, United States
University of Michigan Health System48109, Ann ArborMichigan, United States
Rutgers Cancer Institute of New Jersey08903, New BrunswickNew Jersey, United States
University of Wisconsin53705, MadisonWisconsin, United States
Sponsors and collaborators
Nataliya Uboha
Lead sponsor
Big Ten Cancer Research Consortium
Sponsor institution
Arcus Biosciences, Inc.
Collaborator
Gilead Sciences
Collaborator
University of Wisconsin, Madison
Collaborator
Source ClinicalTrials.gov