AZD5863 for Advanced Solid Cancers

Recruiting at 22 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, Anticoagulants

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: Unknown

240 Participants Needed

Trial Summary

What is the purpose of this trial?

This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes participants on anticoagulation therapy and those requiring chronic immunosuppressive therapy. It's best to discuss your specific medications with the trial team.

Eligibility Criteria

Adults over 18 with advanced solid tumors like pancreatic, esophageal, or stomach cancer can join this trial if they've had at least one prior treatment for advanced cancer. They need a life expectancy of 12 weeks or more, measurable tumor lesions, and positive CLDN18.2 expression in their tumor cells. Good physical health is required (ECOG PS: 0-1), as well as proper organ and bone marrow function.

Inclusion Criteria

My organs and bone marrow are functioning well, as tested within the last 28 days.

I am fully active or restricted in physically strenuous activity but can do light work.

My tumor tests positive for CLDN18.2.

Exclusion Criteria

I had severe side effects from previous immune cell therapies.

I have had an autoimmune or inflammatory disorder in the last 3 years.

I do not have active HIV, hepatitis B/C, or any uncontrolled infections.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive AZD5863 monotherapy in a dose-escalation format to determine the maximum tolerated dose

Duration of Cycle 1

Multiple visits for dose administration and monitoring

Dose Expansion

Participants receive AZD5863 monotherapy at the determined dose to further evaluate safety and efficacy

Approx. 2 years

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days post last dose

Follow-up visits for safety assessments

Treatment Details

Interventions

• AZD5863

Trial Overview The study tests AZD5863, an experimental drug that targets specific proteins on T cells and cancer cells to fight the tumor. It's given to see if it's safe and effective against certain types of solid tumors that have spread or cannot be removed by surgery.

Participant Groups

Group I: Module 2: AZD5863 Monotherapy Subcutaneous (SC) Experimental Treatment 1 Intervention

Module 2: AZD5863 Subcutaneous (SC) Monotherapy

Group II: Module 1: AZD5863 Monotherapy Intravenous (IV) Experimental Treatment 1 Intervention

Module 1: AZD5863 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