RecruitingPhase 1Phase 2NCT06267729

Study of AZD0754 in Participants With Metastatic Prostate Cancer

A Phase I/II Open Label Study to Evaluate the Safety, Cellular Kinetics, and Efficacy of AZD0754, a Chimeric Antigen Receptor (CAR) T-cell Therapy Directed Against STEAP2, in Adult Participants With Metastatic Prostate Cancer: APOLLO


Sponsor

AstraZeneca

Enrollment

60 participants

Start Date

Mar 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety, tolerability, and antitumour activity of AZD0754 CAR T-cell therapy in participants with metastatic prostate cancer.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AZD0754 in patients with metastatic prostate cancer that has continued to grow despite hormone therapy (castration-resistant), to evaluate how safe it is and whether it can slow or stop cancer progression. **You may be eligible if...** - You are 18 or older - You have metastatic prostate cancer confirmed by biopsy - Your cancer continues to grow despite having very low testosterone levels (castration-resistant) - Your PSA level is 1 ng/mL or higher - Your cancer has shown evidence of progression in the past 6 months - You are continuing androgen deprivation therapy (e.g., LHRH analog injections) **You may NOT be eligible if...** - You have small cell or neuroendocrine prostate cancer - You have had prior treatment with certain PARP inhibitors or platinum chemotherapy - You have active serious infections or significant organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAZD0754

Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce AZD0754. During AZD0754 production, subjects may receive bridging therapy for disease control. Upon successful generation of AZD0754 product, subjects will receive treatment with AZD0754 therapy. Study treatment will include lymphodepleting chemotherapy. After lymphodepleting chemotherapy AZD0754 is administered intravenously and patients will be required to stay at the hospital for a protocol specified monitoring period.

BIOLOGICALAZD2287

This is an Optional arm of the study, which subjects will separately consent to if they would like to participate. Subjects will receive doses of a radioactive imaging agent called AZD2287 followed by SPECT/CT imaging scans at two time points.


Locations(15)

Research Site

Duarte, California, United States

Research Site

Tampa, Florida, United States

Research Site

Atlanta, Georgia, United States

Research Site

Westwood, Kansas, United States

Research Site

Boston, Massachusetts, United States

Research Site

Boston, Massachusetts, United States

Research Site

St Louis, Missouri, United States

Research Site

Hackensack, New Jersey, United States

Research Site

New York, New York, United States

Research Site

New York, New York, United States

Research Site

Philadelphia, Pennsylvania, United States

Research Site

Dallas, Texas, United States

Research Site

Houston, Texas, United States

Research Site

East Melbourne, Australia

Research Site

Pamplona, Spain

View Full Details on ClinicalTrials.gov

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NCT06267729


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