AZD9793 for Liver Cancer

(RHEA-1 Trial)

Recruiting at 4 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Autoimmune disorders, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

304 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have unresolved side effects from previous cancer treatments or if you have taken certain cancer therapies recently. It's best to discuss your current medications with the trial team.

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive AZD9793 monotherapy intravenously or subcutaneously to determine the maximum tolerated dose

4-8 weeks

Weekly visits for dose adjustments and monitoring

Dose Expansion

Participants receive AZD9793 at the determined dose to further evaluate safety and efficacy

12 weeks

Bi-weekly visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Long-term Follow-up

Participants are monitored for long-term safety and survival outcomes

Up to 2 years

Treatment Details

Interventions

• AZD9793

Trial Overview 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.

Participant Groups

Group I: Module 2: AZD9793 Subcutaneous (SC) monotherapy Experimental Treatment 1 Intervention

Module 2: AZD9793 Subcutaneous (SC) monotherapy

Group II: Module 1: AZD9793 Intravenous (IV) monotherapy Experimental Treatment 1 Intervention

Module 1: AZD9793 Intravenous (IV) monotherapy

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology