Phase 2 Study of Gemcitabine, Cisplatin, Quemliclustat (AB680) and Zimberelimab(AB122) during First-Line Treatment of Advanced Biliary Tract Cancers
Anita Turk, MD
Primary Investigator
Brief description of study
What is the purpose of this study?
The purpose of this study is to find out if adding two drugs called quemliclustat and zimberelimab to the usual chemotherapy drugs can increase the amount of time a person lives with biliary tract cancer without it getting worse. Researchers also want to study the safety and effectiveness of the combination.
Detailed description of study
What will happen during the study?
Study participants will receive 4 cycles of combination therapy as detailed below. After 4 cycles (~6
months), cisplatin will be discontinued, while gemcitabine will be continued as long as clinically
tolerated at the discretion of the treating physician. Additional chemotherapy dose modifications will be
allowed as clinically indicated. Subjects will be treated until disease progression or development of
intolerable toxicities
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Biliary Tract Cancers
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria:
1. Patients with cytologically or histologically confirmed BTC.
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. ECOG Performance Status from 0-2.
4. Adequate bone marrow function, as assessed by:
a. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
b. Platelet count ≥ 100,000 x 109/L
c. Hemoglobin ≥ 8 g/dL
5. Adequate renal function, with creatinine < 1.5 x the upper limit of
institutional normal (ULN) or Cockcroft calculated creatinine clearance
of ≥60 mL/min.
6. Adequate liver function, as measured by:
a. AST and ALT ≤ 3 x ULN
b. Total bilirubin ≤ 1.5 x ULN
Exclusion Criteria:
1. History of autoimmune disease requiring systemic treatment in the past
2 years.
2. Pregnancy or breastfeeding.
3. Active infection requiring systemic therapy.
4. History of solid organ or allogeneic bone marrow transplantation.
5. Underlying medical condition that will make administration of study
drugs hazardous in the opinion of the treating physician.
6. Prior treatment with immune checkpoint inhibitors.
