Actively Recruiting
Study of AZD0754 in Participants With Metastatic Prostate Cancer
Led by AstraZeneca · Updated on 2026-02-23
60
Participants Needed
15
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of AZD0754 in Participants With Metastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years or older at the time of signing the informed consent form.
- Histologically confirmed metastatic adenocarcinoma of the prostate without neuroendocrine or small cell features.
- Castration-resistant prostate cancer with disease progression despite castration by surgery or hormone therapy.
- Measurable PSA level of 1 ng/mL or higher.
- Evidence of disease progression within 6 months prior to screening by imaging or PSA criteria.
- Previous treatment with novel hormonal agents (abiraterone, enzalutamide, apalutamide, darolutamide) and taxane chemotherapy; exceptions allowed if ineligible or refusing taxanes.
- For BRCA1/2 mutation carriers, prior PARP inhibitor treatment or intolerance.
- For non-BRCA homologous recombination repair deficiency, PARP inhibitor treatment at investigator's discretion.
- For high microsatellite instability or deficient DNA mismatch repair, prior checkpoint inhibitor treatment or ineligibility/intolerance.
- ECOG performance status of 0 or 1 prior to leukapheresis.
- Life expectancy greater than 12 weeks before leukapheresis.
- Adequate organ and bone marrow function.
- Consent to provide tumor tissue for STEAP2 expression and biomarker analysis, with fresh or archival biopsies not older than 10 years.
You will not qualify if you...
- Weight less than 39 kg.
- History of other primary malignancy except low-risk cancers treated curatively with no active disease for at least 2 years.
- Known brain metastases.
- Prior solid organ transplant.
- Active or prior autoimmune or inflammatory disorders, except certain stable or controlled conditions.
- Stroke, brain bleeding, or seizures within 6 months prior to leukapheresis.
- Symptomatic or uncontrolled serious cardiac arrhythmias.
- Prolonged QT interval or family history of long QT syndrome.
- Uncontrolled illnesses including infections, heart failure, lung disease, unstable angina, recent heart attack, or bleeding disorders.
- Active uncontrolled epilepsy.
- Persistent moderate or worse toxicities from prior cancer treatments, except alopecia.
- HIV positive status.
- Active hepatitis C infection.
- Hepatitis B infection unless controlled and on antiviral therapy.
- Use of full-dose therapeutic anticoagulants or thrombolytics from consent to 28 days post AZD0754 infusion.
- Recent major surgery or certain corticosteroid/immunomodulator treatments near leukapheresis.
- Recent anticancer therapies within specified washout periods.
- Concurrent anticancer treatments except specified allowed therapies.
- Live vaccines within 30 days prior to leukapheresis.
- Prior CAR T-cell therapy or therapy targeting STEAP2.
- Known life-threatening allergy or intolerance to AZD0754 or its components.
- In Australia, participants with human T-lymphotropic virus (HTLV).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Research Site
Duarte, California, United States, 91010
Actively Recruiting
2
Research Site
Tampa, Florida, United States, 33612
Actively Recruiting
3
Research Site
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Research Site
Westwood, Kansas, United States, 66205
Not Yet Recruiting
5
Research Site
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
6
Research Site
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
7
Research Site
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Research Site
Hackensack, New Jersey, United States, 07601
Actively Recruiting
9
Research Site
New York, New York, United States, 10032
Actively Recruiting
10
Research Site
New York, New York, United States, 10065
Actively Recruiting
11
Research Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
Research Site
Dallas, Texas, United States, 75235
Not Yet Recruiting
13
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
14
Research Site
East Melbourne, Australia, 3002
Actively Recruiting
15
Research Site
Pamplona, Spain, 31008
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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