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CAR T-cell Therapy

AZD0754 for Prostate Cancer (APOLLO Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with castration-resistant prostate cancer as defined by disease progression despite castration by orchiectomy or ongoing luteinising hormone-releasing hormone analogue

Participants with a histologically confirmed diagnosis of metastatic adenocarcinoma of the prostate without known neuroendocrine differentiation or small cell features

Must not have

Participants with known brain metastases

Participants with active, uncontrolled epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test the safety and effectiveness of AZD0754 CAR T-cell therapy in people with advanced prostate cancer."

Who is the study for?

This trial is for individuals with metastatic prostate cancer. Participants should meet specific health criteria to be eligible, but the exact inclusion and exclusion details are not provided.

What is being tested?

The study is testing AZD0754 CAR T-cell therapy's safety, how well people can handle it, and its effectiveness in treating metastatic prostate cancer.

What are the potential side effects?

While specific side effects of AZD0754 are not listed, common side effects of CAR T-cell therapies may include flu-like symptoms, fatigue, fever, and potential neurological events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is growing despite hormone therapy.

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My prostate cancer has spread, and it's not small cell or neuroendocrine type.

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I have had treatments like abiraterone or taxane for prostate cancer, or I cannot or will not take taxane.

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My PSA level is at least 1 ng/mL and it has increased in the last 6 months.

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I have HRR deficiency or a BRCA mutation and have tried or can't tolerate PARP inhibitors.

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I have received at least one checkpoint inhibitor treatment for my cancer with high microsatellite instability.

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastases.

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I have epilepsy that is not well-controlled.

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I haven't had a stroke, brain bleed, or seizure in the last 6 months.

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I have an active hepatitis C infection.

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I weigh less than 42 kg.

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I have an irregular heartbeat.

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I have not received any live vaccines in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of participants with Dose-limiting Toxicity (DLTs)/DLT-like events, Adverse Events (AEs), including Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs).

Secondary study objectives

Best Overall Response (BOR)

Biomarker - STEAP2 expression in Tumor

Disease Control Rate (DCR)

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