First in human study to evaluate AZD9793 in participants with advanced or metastatic solid tumours - RHEA-1

Study identifier:D7040C00001

ClinicalTrials.gov identifier:NCT06795022

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

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)

Medical condition

Hepatocellular Carcinoma

Phase

Phase 1/2

Healthy volunteers

No

Study drug

AZD9793 Intravenous (IV) monotherapy, AZD9793 Subcutaneous (SC) monotherapy)

Sex

All

Estimated Enrollment

304

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 27 Feb 2025
Estimated Primary Completion Date: 28 Jan 2028
Estimated Study Completion Date: 15 Jun 2028

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2025 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria