RecruitingPhase 1Phase 2NCT06795022

First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours

A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD9793, a T Cell-engaging Antibody Targeting Glypican-3 (GPC3) in Adult Participants With Advanced or Metastatic Solid Tumours (RHEA-1)


Sponsor

AstraZeneca

Enrollment

304 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This research is designed to determine if experimental treatment with AZD9793, a T cell-engaging antibody that targets GPC3, is safe, tolerable and has anti-cancer activity in patients with advanced or metastatic solid tumours which are GPC3+.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study of a new drug called AZD9793, designed to target a protein called GPC3 that is found on certain cancer cells. It is being tested in people with advanced liver cancer (hepatocellular carcinoma) or other solid tumors that have spread or cannot be removed surgically. **You may be eligible if...** - You are 18 or older - Your tumor tests positive for the GPC3 protein - You have advanced, recurrent, or metastatic liver cancer (HCC) or another solid tumor - Your cancer has at least one measurable lesion on imaging - You are in reasonably good health and able to carry out daily activities (ECOG 0-1) - Your organs (liver, kidneys, bone marrow) are functioning adequately - You have a life expectancy of at least 12 weeks **You may NOT be eligible if...** - Your tumor does not express GPC3 - You have severe organ dysfunction - You are pregnant or not using adequate contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD9793 Intravenous (IV) monotherapy

T cell-engaging antibody that targets GPC3 on tumour cells

DRUGAZD9793 Subcutaneous (SC) monotherapy

T cell-engaging antibody that targets GPC3 on tumour cells


Locations(20)

Research Site

La Jolla, California, United States

Research Site

Los Angeles, California, United States

Research Site

Baltimore, Maryland, United States

Research Site

St Louis, Missouri, United States

Research Site

Hackensack, New Jersey, United States

Research Site

Houston, Texas, United States

Research Site

Chengdu, China

Research Site

Guangzhou, China

Research Site

Harbin, China

Research Site

Shanghai, China

Research Site

Pokfulam, Hong Kong

Research Site

Shatin, Hong Kong

Research Site

Kashiwa, Japan

Research Site

Yokohama, Japan

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Barcelona, Spain

Research Site

Pamplona, Spain

Research Site

Taipei, Taiwan

Research Site

Taoyuan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06795022


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