Status:
RECRUITING
Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Metastatic Prostate Cancer
Eligibility:
MALE
18-130 years
Phase:
PHASE1
PHASE2
Brief Summary
The main purpose of this study is to assess the safety and tolerability of AZD0516 as monotherapy and/or in combination with other anti-cancer agents for treatment of metastatic prostate cancer.
Detailed Description
This is a first-in-human modular, Phase I/IIa, open-label, multi-centre study of AZD0516 in participants with metastatic prostate cancer. The study will consist of individual modules, each evaluating ...
Eligibility Criteria
Inclusion
- Main
- Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the prostate. Focal high grade neuroendocrine features are permitted.
- Measurable PSA ≥ 1 μg/L (≥ 1 ng/mL).
- Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) within ≤ 28 days before treatment allocation. Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) modulator for participants who have not undergone bilateral orchiectomy must be initiated at least 2 weeks prior to consent and must continue throughout the study.
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
- Adequate organ and marrow function in the absence of blood transfusion or growth factor support (within 21 days prior to the scheduled first dose of study intervention).
- Provision of baseline archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumour sample is mandatory.
- Documented current evidence of metastatic prostate cancer
- Life expectancy of at least 12 weeks in the opinion of the investigator
- Documented mCRPC progression at screening as assessed by the investigator with at least one of the following criteria:
- PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the screening visit should be ≥ 1 μg/L (1 ng/mL).
- Radiographic disease progression in soft tissue based on response evaluation criteria in solid tumors (RECIST) v1.1 criteria with or without PSA progression as per prostate cancer working group 3 (PCWG3).
- Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on a bone scan as per PCWG3 with or without PSA progression.
- Main
Exclusion
- Cancer related spinal cord compression, or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent for at least 4 weeks prior to study enrolment.
- History of leptomeningeal carcinomatosis.
- Unresolved toxicities of Grade ≥ 2 (National Cancer Institute Common Terminology Criteria for Adverse Events v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy).
- Uncontrolled intercurrent illness within the last 12 months.
- Cardiovascular disorder (History of arrhythmia, uncontrolled hypertension, symptomatic hypotension, history of brain perfusion problems, symptomatic heart failure, prior or current cardiomyopathy, severe valvular heart disease)
- History of malignancy
- History of non-infectious interstitial lung disease (ILD)/pneumonitis
- Active infection exclusions, including tuberculosis and infections with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).
- Any known predisposition to bleeding
- Clinically severe pulmonary compromise
- Participants with Myelodysplastic syndrome (MDS)/Acute Myeloid Leukemia (AML) or with features suggestive of MDS/AML.
- Previous treatment with a STEAP2 targeting modality, chemotherapeutic agent that inhibits topoisomerase activity or metabolic enzymes.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 18 2029
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT07181161
Start Date
October 1 2025
End Date
January 18 2029
Last Update
December 17 2025
Active Locations (51)
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1
Research Site
Fayetteville, Arkansas, United States, 72703
2
Research Site
Los Angeles, California, United States, 90095
3
Research Site
Boston, Massachusetts, United States, 02114
4
Research Site
Ann Arbor, Michigan, United States, 48109