Phase 2 Study of Gemcitabine, Cisplatin, Quemliclustat (AB680) and Zimberelimab(AB122) during First-Line Treatment of Advanced Biliary Tract Cancers
Investigation of Combination Therapy for Advanced Biliary Tract Cancer
Anita Turk, MD
Primary Investigator
Brief description of 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
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
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Age: 18 years - 100 years
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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 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.
This study investigates the effects of combining investigational medications with standard chemotherapy for advanced biliary tract cancer. Biliary tract cancer is a type of cancer that affects the bile ducts, which are tubes that carry bile from the liver to the gallbladder and small intestine. The purpose of this study is to see if adding investigational medications to the usual chemotherapy can improve the time patients live without their cancer getting worse.
Participants in the study will receive a combination of investigational medications and chemotherapy for 4 cycles, which is about 6 months. After these cycles, one of the chemotherapy drugs will be stopped, but the other will continue as long as it is tolerated. The study will monitor the safety and effectiveness of this treatment approach.
- Who can participate: Participants must have advanced biliary tract cancer and have not received treatment for advanced disease. They should have good organ function and an ECOG Performance Status of 0-2.
- Study details: Participants will receive investigational medications with chemotherapy until the disease progresses or side effects become too severe.
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