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)

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. - GEMINI-Hepatobiliary

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230260

Enrollment

260

Registered

2023-07-27

Start date

2023-09-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma, Biliary Tract Cancer

Interventions

- Drug: MEDI5752 CTLA-4/Anti-PD-1 Bispecific Antibody - Drug: Bevacizumab 15 mg/kg, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age 18 years or more 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

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
1. Objective response rate (ORR) [ Time Frame: Through study completion, an average of 2 years ] ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1 (For HCC sub-study 1) 2. The number of participants with adverse events/serious adverse events [ Time Frame: Through study completion, an average of 2 years ] Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline. 3. Progression free survival (PFS) [ Time Frame: Through study completion, an average of 2 years ] PFS is defined as the time from the start of studyintervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression, whichever occurs first. (For BTC sub-study 2)	—

Measure

Time frame

1. Objective response rate (ORR) [ Time Frame: Through study completion, an average of 2 years ] ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1 (For HCC sub-study 1) 2. The number of participants with adverse events/serious adverse events [ Time Frame: Through study completion, an average of 2 years ] Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline. 3. Progression free survival (PFS) [ Time Frame: Through study completion, an average of 2 years ] PFS is defined as the time from the start of studyintervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression, whichever occurs first. (For BTC sub-study 2)

—

Countries

China, Hong Kong, Italy, Japan, Republic of Korea, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactKazushige Hibi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026