NCT06795022

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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+.

Detailed description

This is a first-time in human, modular Phase I/II, open-label multicentre study of AZD9793 monotherapy administered intravenously (Module 1), or AZD9793 monotherapy administered subcutaneously (Module 2) in patients with advanced or metastatic solid tumours. Each module contains dose-escalation (Part A) and dose-expansion (Part B).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	AZD9793 Intravenous (IV) monotherapy	T cell-engaging antibody that targets GPC3 on tumour cells
DRUG	AZD9793 Subcutaneous (SC) monotherapy	T cell-engaging antibody that targets GPC3 on tumour cells

Timeline

• Start date: 2025-03-27
• Primary completion: 2028-02-25
• Completion: 2028-07-25
• First posted: 2025-01-27
• Last updated: 2026-04-06

Locations

20 sites across 7 countries: United States, China, Hong Kong, Japan, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study