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RecruitingPhase 1, Phase 2NCT06267729

Study of AZD0754 in Participants With Metastatic Prostate Cancer

◆ AI Clinical Summary

This study tests a new type of cancer treatment called CAR T-cell therapy (AZD0754) in men with prostate cancer that has spread to other parts of the body. Researchers will evaluate whether this treatment is safe and whether it can help slow or stop the growth of cancer.

Key Objective:This trial is testing whether CAR T-cell therapy can effectively treat metastatic prostate cancer while being safe and well-tolerated.

Who to Consider:Men with metastatic prostate cancer who have limited treatment options or who have not responded well to standard treatments should consider enrolling.

Trial Parameters

ConditionMetastatic Prostate Cancer
SponsorAstraZeneca
Study TypeINTERVENTIONAL
PhasePhase 1, Phase 2
Enrollment60
SexMALE
Min Age18 Years
Max Age130 Years
Start Date2024-03-12
Completion2026-11-24
Interventions
AZD0754AZD2287

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Brief 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 Criteria

Inclusion Criteria: Age 1. Participant must be 18 years or older at the time of signing the informed consent form. Type of Participant and Disease Characteristics 2. Participants with: 1. A histologically confirmed diagnosis of metastatic adenocarcinoma of the prostate without known neuroendocrine differentiation or small cell features. 2. Castration-resistant prostate cancer as defined by disease progression despite castration by orchiectomy or ongoing luteinising hormone-releasing hormone analogue. Participants receiving medical castration therapy with gonadotropin releasing hormone analogues should continue this treatment during the study. 3. Measurable PSA \>/=1 ng/mL AND 4. Evidence of progression within 6 months prior to screening according to one of the following: (i) Radiographic disease progression in soft tissue based on Response Evaluation Criteria in Solid Tumours Version 1.1 criteria with or without PSA progression as per Prostate Cancer Working Group Criteria 3 (PCWG3) (i

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