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RecruitingLast updated: 23 September 2025

This study is recruiting people with metastatic castration-resistant prostate cancer (mCRPC) to assess how safe and tolerable new targeted imaging and treatment agents areA Phase I, First-in-human, Dose Escalation Study Of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Clinical summary

Summary

This study will consist of 2 parts:

Part A (Imaging):

  • Part A (Cold Antibody Exploration): aims to determine the optimal dosing regimen, with or without receiving an unconjugated antibody (called AZD2275) pre-administration to improve the biodistribution of AZD2287, which is a diagnostic imaging agent used to assess PSMA and STEAP2 in prostate cancer cells.
  • Part A Expansion: aims to explore the prevalence of PSMA and STEAP2 expression by imaging.

Part B (Therapeutic):

  • Part B (Actinium-225 Dose Escalation): aims to assess the safety, tolerability and efficacy of escalating doses of AZD2284, which delivers targeted alpha radiation to prostate cancer cells, informed by the optimal dosing regimen identified in Part A.
  • Part B Expansion Cohorts 1 & 2: aims to explore efficacy of AZD2284.

Conditions

This trial is treating people with metastatic castration-resistant prostate cancer who have had prior bilateral orchiectomy and/or ongoing androgen-deprivation therapy

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate or neuroendocrine differentiated prostate cancer.
  • Must have had prior bilateral orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
  • At least one metastatic lesion present on baseline Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or bone scan obtained ≤ 28 days prior to the first dose of Investigational Medicinal Product (IMP). Participants may have non-measurable lesions including bone only metastases.
  • Adequate organ function

Exclusion

  • Treatment with any radiopharmaceutical within 6 weeks of the first dose of Investigational Medicinal Product (IMP).
  • Radiation therapy (RT) within 28 days prior to the first dose and all RT-related events have not recovered to Grade ≤ 1.
  • Administration of any systemic cytotoxic or investigational therapy ≤ 28 days of the first dose of IMP or 5 half-lives, whichever is shorter.
  • All prior treatment-related adverse events must have resolved to Grade ≤ 1.
  • Concurrent severe and/or uncontrolled illness not related to cancer and/or social situation that would limit compliance with study requirements.
  • Known or suspected allergies or contraindications to any of the investigational drugs or any component of the investigational drug formulation.
  • Clinically relevant proteinuria

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AstraZeneca

Scientific Title

A Phase I, First-in-human, Dose Escalation Study Of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer

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