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RecruitingHepatocellular CarcinomaBiliary Tract Cancer

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

Eligible age

18+ yrs

Accepts

All genders

Locations

8 states

Healthy volunteers

No

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About this study

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.

Sponsor: AstraZeneca

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's recruiting

Alabama

Birmingham

California

Costa Mesa · Los Angeles · Orange

Florida

Miami Beach

Kansas

Kansas City

New York

New York

Texas

Dallas

Virginia

Fairfax

Source: ClinicalTrials.gov · NCT05775159 · last updated 2026-04-17