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

Running, not enrolling · Phase 2

Conditions studied: Hepatocellular Carcinoma, Biliary Tract Cancer

In brief

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.

Key facts

Study ID

NCT05775159

Run by

AstraZeneca

People needed

294

Starts

2023-04-24

Expected to finish

2027-10-28

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — New York, New York, United States
• Research Site — Beijing, China
• Research Site — Beijing, China
• Research Site — Beijing, China
• Research Site — Chengdu, China
• Research Site — Chengdu, China
• Research Site — Chongqing, China
• Research Site — Fuzhou, China
• Research Site — Guangzhou, China
• Research Site — Guangzhou, China
• Research Site — Harbin, China
• Research Site — Nanning, China
• Research Site — Shanghai, China
• Research Site — Hong Kong, Hong Kong
• Research Site — Shatin, Hong Kong
• Research Site — Florence, Italy
• Research Site — Milan, Italy
• Research Site — Naples, Italy
• Research Site — Rozzano, Italy
• Research Site — Chūōku, Japan
• Research Site — Kashiwa, Japan
• Research Site — Yokohama, Japan
• Research Site — Seongnam-si, South Korea
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea

Full record on ClinicalTrials.gov

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