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Clinical Trials List

Protocol NumberD7987C00001
NCT Number(ClinicalTrials.gov Identfier)NCT05775159
Active

2023-01-30 - 2028-11-27

Phase II

Recruiting8

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)

  • Trial Applicant

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chen-Chun Lin Digestive System Department
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 盧勝男 Digestive System Department
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Lung Yu Digestive System Department
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳鴻昌 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ying-Chun Shen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TENG-YU LEE Digestive System Department
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳新炫 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Hepatocellular Carcinoma

Objectives

We are conducting this trial to gain a deeper understanding of the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of MEDI5752 and AZD2936, and also hope to gain a better understanding of the diseases and related health issues being studied. MEDI5752, a laboratory-made antibody, binds to two receptors on immune cells (receptors are proteins on the surface of cells); one is called programmed cell death protein-1 , PD-1), and the other is called cytotoxic T lymphocyte-associated antigen 4 (CTLA-4). The bispecific form of MEDI5752 blocks both signals with just one drug. We hope that by blocking these receptors, immune cells will enhance the immune system's ability to detect and fight cancer. AZD2936 is an anti-human PD-1 and T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT). Bispecific, humanized antibodies. In preclinical trials, dual blockade of TIGIT and PD-1 with AZD2936 enhanced human T cell function and promoted anti-tumor immune responses.

Test Drug

MEDI5752
AVASTIN
LENVIMA
AZD2936

Active Ingredient

MEDI5752
Bevacizumab
Lenvatinib
AZD2936

Dosage Form

IV Infusion
IV Infusion
PO
IV Infusion

Dosage

250 mg/vial
25 mg/mL
8 mg QD for body weight < 60 kg or 12 mg QD for body weight ? 60 kg
750 mg

Endpoints

Curative effect
• ORR is defined as the proportion of participants with a confirmed CR or a confirmed PR, as determined by the trial moderator at the local trial site according to RECIST 1.1.
• The analysis will include responses from participants within the evaluable analysis set. Participants will be analyzed according to the trial intervention to which they are assigned.
• Data obtained from the first dose until exacerbation, or if no exacerbation, until the last evaluable assessment, will be included in the ORR assessment, regardless of whether the participant discontinues treatment. Participants who discontinue treatment without response or worsening, receive subsequent therapy, and then respond will not be included as ORR responders.
• The assessment item of interest is the estimate of ORR.

Safety and tolerability
• Incidence of adverse events (AEs), adverse events of special interest (AESI), serious adverse events (SAEs), and AEs leading to treatment discontinuation
• Body checkup
• Laboratory test results
• Vital signs
• 12-lead ECG
The analysis will include participants in the security analysis set.
Participants will be analyzed based on their actual trial intervention.

Inclution 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

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.

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    290 participants

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