Master Protocol of Novel Immunomodulators as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Hepatobiliary Cancer

Phase 1

Recruiting

• Conditions: Advanced Hepatobiliary Cancer; MedDRA version: 20.0Level: PTClassification code: 10073071Term: Hepatocellular carcinoma Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10008593Term: Cholangiocarcinoma Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10017614Term: Gallbladder cancer Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code: 10004598Term: Bile duct carcinoma Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-502317-29-00
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-10
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 260

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

HCC only: History of allogeneic organ transplantation or in the waiting-list 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., HCC only: History of hepatic encephalopathy within 12 months prior to treatment allocation., Previous treatment in the present study., Participants co-infected with HBV and hepatitis D virus (HDV), BTC only: History of allogeneic organ transplantation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified