AZD9793 for Liver Cancer
(RHEA-1 Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for individuals with advanced or metastatic solid tumors, specifically liver cancer or hepatocellular carcinoma. Participants must have tumors that test positive for a protein called GPC3.

Inclusion Criteria

My organs and bone marrow are functioning well.

Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

I am following local guidelines for contraception as required.

+8 more

Exclusion Criteria

I have not had radiation in the last 14 days, except for specific palliative reasons.

My heart condition meets the study's requirements.

Participation in another clinical study with an investigational product administered in the last 21 days or 5 half-lives whichever is shorter prior to enrolment

+13 more

Participant Groups

The study is testing AZD9793, an experimental antibody targeting the GPC3 protein on tumor cells. It's given as monotherapy either through IV (intravenous) or SC (subcutaneous) injections to evaluate safety, tolerability, and anti-cancer effects.

2Treatment groups

Experimental Treatment

Group I: Module 2: AZD9793 Subcutaneous (SC) monotherapyExperimental Treatment1 Intervention

Module 2: AZD9793 Subcutaneous (SC) monotherapy

Group II: Module 1: AZD9793 Intravenous (IV) monotherapyExperimental Treatment1 Intervention

Module 1: AZD9793 Intravenous (IV) monotherapy