Testing AZD0516 alone and combined in metastatic prostate cancer
Tests AZD0516 safety in adults with prostate cancer that has spread.
Plain-language title generated from the registry record
Registry title: Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer
Key facts
- Where
- Milan, Naples, Rome, and Rozzano, ItalySee the 6 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 130 years old?
Source: NCT07181161, who can take part
Where in Italy
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyNot yet recruiting
- Istituto Europeo di Oncologia s.r.lMilan, ItalyNot yet recruiting
- Ospedale San Raffaele S.r.l.Milan, ItalyNot yet recruiting
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyNot yet recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNot yet recruiting
- Humanitas Mirasole S.p.A.Rozzano, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07181161EU 2024-520026-11-00
- Record updated
- 22 October 2026
- Original description
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.Read full original descriptionShow less
A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Metastatic Prostate Cancer
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.
Main Inclusion Criteria:; 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 Criteria:; 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.