Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer

Summary

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.

Eligibility

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:

* 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.

Conditions5

Interventions6

Locations10 sites

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