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

1. Age ≥18 years at the time of signing the ICF.
2. Provision of a signed and dated written ICF.
3. Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology.
4. Adequate organ and bone marrow function.
5. At least 1 measurable not previously irradiated lesion per RECIST 1.1
6. Life expectancy of at least 12 weeks at the time of screening.
7. Willing and able to provide an adequate tumor sample.

Exclusion criteria

1. History of allogeneic organ transplantation or in the waiting-list of allogeneic organ transplantation.
2. Active or prior documented autoimmune or inflammatory disorders.
3. Uncontrolled intercurrent illness.
4. History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency.
5. Active infection, brain metastases or spinal cord compression.
6. History of hepatic encephalopathy within 12 months prior to treatment allocation.
7. Previous treatment in the present study.
8. For substudy 1, participants co-infected with HBV and hepatitis D virus (HDV).

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.