Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
About the study
GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Age ≥18 years at the time of signing the ICF.
- Provision of a signed and dated written ICF.
- Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology.
- Adequate organ and bone marrow function.
- At least 1 measurable not previously irradiated lesion per RECIST 1.1
- Life expectancy of at least 12 weeks at the time of screening.
- Willing and able to provide an adequate tumor sample.
EXCLUSION CRITERIA
Exclusion Criteria:
- History of allogeneic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness.
- History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency.
- Active infection, brain metastases or spinal cord compression.
- Participants co-infected with HBV and hepatitis D virus (HDV).
- Previous treatment in the present study.
- For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Hepatocellular Carcinoma,Biliary Tract Cancer
Age
18+
Phase
PHASE2
Participants Needed
260
Est. Completion Date
Jan 26, 2027
Treatment Type
INTERVENTIONAL
Sponsor
AstraZeneca
ClinicalTrials.gov NCT Identifier
NCT05775159
Study Number
D7987C00001
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