For Healthcare Professionals

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

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About the 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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Age ≥18 years at the time of signing the ICF.
  2. Provision of a signed and dated written ICF.
  3. Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology.
  4. Adequate organ and bone marrow function.
  5. At least 1 measurable not previously irradiated lesion per RECIST 1.1
  6. Life expectancy of at least 12 weeks at the time of screening.
  7. Willing and able to provide an adequate tumor sample.

EXCLUSION CRITERIA

Exclusion Criteria:


  1. History of allogeneic organ transplantation.
  2. Active or prior documented autoimmune or inflammatory disorders.
  3. Uncontrolled intercurrent illness.
  4. History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency.
  5. Active infection, brain metastases or spinal cord compression.
  6. Participants co-infected with HBV and hepatitis D virus (HDV).
  7. Previous treatment in the present study.
  8. For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study Details


Contition

Hepatocellular Carcinoma,Biliary Tract Cancer

Age

18+

Phase

PHASE2

Participants Needed

260

Est. Completion Date

Jan 26, 2027

Treatment Type

INTERVENTIONAL


Sponsor

AstraZeneca

ClinicalTrials.gov NCT Identifier

NCT05775159

Study Number

D7987C00001

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