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Clinical Trial ยท PHASE1 ยท Recruiting

Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer

22 October 2026 NCT07181161 ClinicalTrials.gov โ†—
✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE1
Participants
MALE
Age Range
18 Years โ€“ 130 Years

About This Trial

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.

Who Can Join?

Main Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the prostate. Focal high grade neuroendocrine features are permitted. * Measurable PSA โ‰ฅ 1 ฮผg/L (โ‰ฅ 1 ng/mL). * Surgically or medically castrated with serum testosterone levels โ‰ค 50 ng/dL (โ‰ค 1.75 nmol/L) within โ‰ค 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…

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