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. - GEMINI-Hepatobiliary

Hibi Kazushige0 个研究点目标入组 260 人开始时间: 2023年7月27日最近更新: 2024年5月27日

试验速览

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•Age 18 years or more 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.

•- 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.

发起方

Hibi Kazushige