RecruitingMetastatic Prostate Cancer

Study of AZD0754 in Participants With Metastatic Prostate Cancer

Eligible age

18–130 yrs

Accepts

Men

Locations

10 states

Healthy volunteers

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About this study

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.

Sponsor: AstraZeneca

You may qualify if…

✓ 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:

You may not qualify if…

✕ 1. Participants with weight less than 39 kg
✕ 2. History of another primary malignancy except for malignancy treated with curative intent with no known active disease (≥ 2 years) before the first dose of study intervention and of low potential risk for recurrence. Such exceptions include non-melanoma cancer of the skin that has undergone curative therapy or adequately treated carcinoma in situ without evidence of disease.
✕ 3. Participants with known brain metastases.
✕ 4. Prior solid organ transplantation.
✕ 5. Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion:
✕ 1. Participants with vitiligo or autoimmune alopecia.
✕ 2. Participants with autoimmune hypothyroidism (eg, following Hashimoto thyroiditis) stable on hormone replacement.
✕ 3. Any chronic inflammatory or autoimmune skin condition that does not require systemic therapy.