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

• Status: Not yet recruiting
• Trial end date: 2025-10-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Bevacizumab; Lenvatinib

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:

• History of allogeneic organ transplantation or in the waiting-list 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.

• History of hepatic encephalopathy within 12 months prior to treatment allocation.

• Previous treatment in the present study.

• For substudy 1, participants co-infected with HBV and hepatitis D virus (HDV).