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New treatment option for Metastatic Prostate Cancer
Official title Study of AZD0754 in Participants With Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT06267729
What this study is testing
What is AZD0754?
AZD0754 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 130, men only
You may be able to join if
- Participant must be 18 years or older at the time of signing the informed consent form. Type of Participant and Disease Characteristics
- Participants with:
- A histologically confirmed diagnosis of metastatic adenocarcinoma of the prostate without known neuroendocrine differentiation or small cell features.
- Castration-resistant prostate cancer as defined by disease progression despite castration by orchiectomy or ongoing luteinising hormone-releasing...
- Measurable PSA \>/=1 ng/mL AND
You likely can't join if
- Participants with weight less than 39 kg
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease (≥ 2 years) before the first...
- Participants with known brain metastases.
- Prior solid organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion:
- Participants with vitiligo or autoimmune alopecia.
See the full eligibility criteria
Who can join
- Participant must be 18 years or older at the time of signing the informed consent form. Type of Participant and Disease Characteristics
- Participants with:
- A histologically confirmed diagnosis of metastatic adenocarcinoma of the prostate without known neuroendocrine differentiation or small cell features.
- 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...
- Measurable PSA \>/=1 ng/mL AND
- 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...
- Participant has previously received a NHA (ie, abiraterone, enzalutamide, apalutamide, darolutamide) and a taxane as part of their treatment for prostate cancer (whether before or in the metastatic castration-resistant...
- For participants with pathogenic mutations in BRCA1 or BRCA2, they must also have received a PARP-inhibitor or be intolerant of this therapy. For participants with non-BRCA HRR deficiency disease, treatment with a...
- For participants who have high microsatellite instability or deficient DNA mismatch repair they must also have received at least one line of checkpoint inhibitors (ie, pembrolizumab), not be eligible for, or be...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to apheresis.
- Minimum life expectancy of \> 12 weeks prior to apheresis in the opinion of the Investigator
- Adequate organ and marrow function.
- Consent and provision of tumour material to assess STEAP2 expression and other correlative biomarkers retrospectively with pre- and post-treatment biopsies. Fresh baseline and on-treatment biopsies are required unless...
What rules you out
- Participants with weight less than 39 kg
- 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...
- Participants with known brain metastases.
- Prior solid organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion:
- Participants with vitiligo or autoimmune alopecia.
- Participants with autoimmune hypothyroidism (eg, following Hashimoto thyroiditis) stable on hormone replacement.
- Any chronic inflammatory or autoimmune skin condition that does not require systemic therapy.
- Participants without active disease in the last 5 years may be included, but only after consultation with the Sponsor.
- Participants with coeliac disease controlled by diet alone.
- Stroke, intracranial haemorrhage, or seizure within 6 months of apheresis.
- Cardiac arrhythmias, (such as multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which are symptomatic or require treatment (Common Terminology Criteria for Adverse Events...
- Investigator judgement of one or more of the following:
- Mean resting corrected QT interval \> 470 ms, obtained from triplicate electrocardiograms (ECGs) performed at screening.
- History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and be associated with Torsades de...
- Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active known infection, cardiomyopathy of any aetiology, symptomatic congestive heart failure defined by New York Heart Association class ≥ 3)...
- Active, uncontrolled epilepsy. Participants without active/uncontrolled epilepsy in the last 5 years may be included.
- Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be...
- Seropositive for human immunodeficiency virus (HIV).
- Active hepatitis C infection (HCV). Participants testing positive for HCV antibody are eligible only if the polymerase chain reaction is negative for HCV RNA.
- Participants with hepatitis B virus (HBV) may be included under the following circumstances:
- Negative for hepatitis B surface antigen (HbsAg) and positive for anti-HBc antibody
- Positive for HbsAg, but for \> 6 months have had normal transaminases and HBV DNA levels between 0 - 2000 IU/mL (inactive carrier state) and willing to start and maintain antiviral treatment for at least the duration of...
- HBV DNA levels \> 2000 IU/mL but on prophylactic antiviral treatment for the past 3 months and will maintain the antiviral treatment during the study.
- Local requirements for the testing for infectious diseases and exclusions of applicable participants should be followed per local regulations. Prior/Concomitant Therapy
- Participants may not receive full-dose long-acting oral (eg, warfarin) or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose from the time of informed consent to...
- Received the following:
- Major surgery within 2 weeks prior to apheresis, or planned major surgery within 4 weeks of the study treatment administration (Note: participants with planned surgical procedures to be conducted under local anaesthesia...
- Corticosteroids (except inhaled corticosteroids) or other immunomodulators (including interleukins, interferons, and thymosins) of systemic therapeutic dose, and systemic corticosteroids at doses exceeding 10 mg/day of...
- Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy targeted therapy, biologic therapy, tumour embolisation, or monoclonal antibodies, investigational product) within 5...
- Any concurrent anticancer treatment with the following exceptions:
- Protocol-defined LDC
- Hormonal therapy for non cancer-related conditions (eg, hormone replacement therapy)
- Androgen deprivation therapy with a luteinising-hormone replacement hormone agonist/antagonist is required if needed to maintain testosterone level in the castration range (levels \< 50 ng/dL) and should be continued...
- Participants should not have received any live vaccines within 30 days prior to apheresis. Participants can receive coronavirus (COVID)-19 vaccines, at the discretion of the Investigator, following a benefit/risk...
- Prior treatment with a CAR-T therapy directed at any target or any therapy that is targeted to STEAP2.
- Participants with a known life-threatening allergy, hypersensitivity, or intolerance to AZD0754 or any of the excipients of the product, including dimethylsulfoxide. In addition to the above, the following exclusion...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Westwood, Kansas, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- East Melbourne, Australia
- Pamplona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Westwood, Kansas, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.