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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Gemcitabine
DrugGemcitabine IV: Day 1, 8, 22, and 29 every 42 days
Cisplatin
DrugCisplatin IV: Day 1, 8, 22, and 29 every 42 days of Cycles 1-4 only.
Zimberelimab
DrugZimberelimab IV: Day 1 and 22 every 42 days
Quemliclustat
DrugQuemliclustat IV: Day 1, 15, 29 every 42 days
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Arm AExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Estimate the progression free survival (PFS) with gemcitabine, cisplatin, quemliclustat (AB680) and zimberelimab (AB122) in patients with advanced BTCs.
Progression free survival (PFS), as determined by RECIST v1.1, is defined as the time from study registration to the date of documented disease progression or death from any cause.
Time frame
2 yearsSecondary outcomes
1
Estimate the overall survival (OS)
Overall survival, defined as the time from study enrollment to date of death due to any cause. Subjects without documented death at the time of analysis will be censored at the date of last known contact.
Time frame
2 years2
Estimate the objective response rate (ORR)
Objective response rate, defined as the proportion of subjects with a complete or partial response to treatment according to RECIST, version 1.1.
Time frame
2 years3
Estimate the disease control rate (DCR)
Disease control rate, defined as the proportion of subjects with stable disease, complete or partial response to treatment according to RECIST, version 1.1.
Time frame
2 years4
Estimate the duration of response (DOR)
Duration of Response (DOR) is defined as the time that measurement criteria are met for complete or partial response according to RECIST 1.1 (whichever status is recorded first) until the date recurrent or progressive disease, or death, is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started).
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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