New antibody takes aim at Hard-to-Treat liver cancer

NCT ID NCT06795022

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study tests a new drug called AZD9793 in people with advanced liver cancer that has spread. The drug is an antibody designed to help the body's immune cells find and attack cancer cells. The main goals are to check if the drug is safe and if it can shrink tumors. About 304 adults will take part in this early-phase trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: AZD9793 (an antibody that helps immune cells attack cancer cells)
What this could lead to: If it works, this could point toward a new treatment option for people with advanced liver cancer that has not responded to other therapies.
What could go wrong: This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects from immune activation can be serious.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 304 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Age ≥ 18 at the time of signing the informed consent. * GPC3 positive tumour as determined by a central laboratory using an analytically validated IHC assay. Patients who previously received any therapy targeting GPC3 must undergo central laboratory GPC3 testing on tumour tissue collected after completion of the prior GPC3-targeted therapy. * Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening. * Predicted life expectancy of ≥ 12 weeks. * Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol. * Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol. * Confirmed advanced recurrent and/or metastatic and/or unresectable HCC, which is histopathologically proven based on the criteria established by the World Health Organization. * Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C. * Child-Pugh Score class A. * Previous therapy: Part A: Patients who have received at least one prior line of standard systemic therapy for HCC as per National Comprehensive Cancer Network or other local scientific guidelines and for which a clinical study is the best option for next treatment based on prior response and/or tolerability and/or patient/investigator decision. Part B: Patients must not have received more than one prior line of systemic therapy in the advanced recurrent and/or metastatic setting. Key Exclusion Criteria: * Unresolved toxicity from prior anticancer therapy, including imAEs, of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for vitiligo, peripheral neuropathy related to prior anti-cancer therapy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities. * Prior to enrolment, participation in another clinical study with an investigational product administered in the last 21 days or 5 half-lives whichever is shorter. * CAR-T cell therapy within the last 6 months prior to enrolment on this study. * Known allergy or hypersensitivity to AZD9793 or any of the excipients of the product as outlined in the IB. * Requires chronic immunosuppressive therapy (including steroids \> 10 mg prednisone/day or equivalent). * Received radiation within 14 days prior to first dose of study treatment; palliative radiation to reduce the risk of tumour lysis syndrome (TLS) or CRS/neurotoxicity in participants with bulky disease is permitted. * Undergone a major surgical procedure within 14 days prior to first dose of study treatment days to allow adequate healing * Experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy. * Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS). * Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment. * Cardiac conditions as defined by the protocol. * History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention. * Central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent. * Infectious disease including active human immunodeficiency virus (HIV), and uncontrolled active systemic fungal, bacterial or other infection. * Known fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular malignant cholangiocarcinoma.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma Simpson-Golabi-Behmel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

20 sites in 7 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Research Site
WITHDRAWN

La Jolla, California, 92093, United States
Research Site
RECRUITING

Los Angeles, California, 90089, United States
Research Site
NOT_YET_RECRUITING

Baltimore, Maryland, 21201, United States
Research Site
NOT_YET_RECRUITING

Boston, Massachusetts, 02114, United States
Research Site
RECRUITING

St Louis, Missouri, 63108, United States
Research Site
NOT_YET_RECRUITING

Hackensack, New Jersey, 07601, United States
Research Site
RECRUITING

Houston, Texas, 77030, United States
Research Site
RECRUITING

Chengdu, 610041, China
Research Site
RECRUITING

Guangzhou, 510515, China
Research Site
NOT_YET_RECRUITING

Harbin, 150049, China
Research Site
RECRUITING

Shanghai, 201114, China
Research Site
RECRUITING

Pokfulam, 999077, Hong Kong
Research Site
RECRUITING

Shatin, 000000, Hong Kong
Research Site
RECRUITING

Kashiwa, 277-8577, Japan
Research Site
RECRUITING

Yokohama, 241-8515, Japan
Research Site
NOT_YET_RECRUITING

Seoul, 06351, South Korea
Research Site
RECRUITING

Seoul, 5505, South Korea
Research Site
NOT_YET_RECRUITING

Barcelona, 8035, Spain
Research Site
NOT_YET_RECRUITING

Pamplona, 31005, Spain
Research Site
RECRUITING

Taipei, 10002, Taiwan
Research Site
RECRUITING

Taoyuan, 333, Taiwan

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