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

Description

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.

Conditions

Hepatocellular Carcinoma, Biliary Tract Cancer

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Study Overview

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Study Details

Study overview

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.

A Phase II, Open-Label, Multi-Drug, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary)

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

Condition
Hepatocellular Carcinoma
Intervention / Treatment

-

Contacts and Locations

Birmingham

Research Site, Birmingham, Alabama, United States, 35233

Costa Mesa

Research Site, Costa Mesa, California, United States, 92627

Los Angeles

Research Site, Los Angeles, California, United States, 90089

Orange

Research Site, Orange, California, United States, 92868

Miami Beach

Research Site, Miami Beach, Florida, United States, 33140

Dyer

Research Site, Dyer, Indiana, United States, 46311

Kansas City

Research Site, Kansas City, Kansas, United States, 66103

New York

Research Site, New York, New York, United States, 10065

Dallas

Research Site, Dallas, Texas, United States, 75251

Fairfax

Research Site, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2027-01-26