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Evaluating a new treatment for advanced prostate cancer

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

Phase 1 Interventional AstraZeneca · NCT06879041

This study is testing a new combination of drugs to see if they are safe and effective for people with advanced prostate cancer that hasn’t responded to other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment136 (estimated)
Ages18 Years and up
SexMale
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy, radiation, prednisone
Locations16 sites (Palo Alto, California and 15 other locations)
Trial IDNCT06879041 on ClinicalTrials.gov

What this trial studies

This Phase I clinical trial aims to assess the safety and tolerability of the investigational drug AZD2284, along with AZD2287 and AZD2275, in patients with metastatic castration-resistant prostate cancer. The study is divided into two parts: Part A focuses on determining the optimal dosing regimen and imaging the expression of specific proteins, while Part B involves dose escalation to evaluate the therapeutic efficacy of AZD2284. Participants will undergo various imaging techniques and receive escalating doses of the treatment based on findings from Part A.

Who should consider this trial

Good fit: Ideal candidates include men with histologically confirmed metastatic castration-resistant prostate cancer who have undergone prior androgen-deprivation therapy.

Not a fit: Patients who have received radiopharmaceuticals or radiation therapy recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer that is resistant to standard hormone therapies.

How similar studies have performed: Other studies using radiopharmaceuticals for prostate cancer have shown promising results, indicating potential for success in this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Main Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Histologically confirmed diagnosis of adenocarcinoma of the prostate without strong clinical suspicion of majority neuroendocrine differentiation.
* 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
* Part A only: Metastatic prostate cancer considered to be stable or progressing metastatic castration resistant prostate cancer (mCRPC).
* Part B only: Progressing mCRPC defined as meeting at least one of following documented criteria -

  1. Serum/plasma PSA progression
  2. Soft-tissue progression
  3. Progression of bone disease
* Part B Dose Escalation: Previously treated with at least 2 prior lines of systemic anti-cancer therapy for mCRPC. Prior lines must include:

  1. At least 1 androgen receptor pathway inhibitor (ARPI)
  2. A poly (adp-ribose) polymerase (PARP) inhibitor for participants with known BRCA mutation
  3. A checkpoint inhibitor for participants with known microsatellite instability-high (MSI-H), deficient mismatch pair (dMMR), or tumor mutational burden (TMB) ≥ 10 mut/Mb
* Part B Dose Expansion: Previously treated with at least 1 prior line of systemic anti-cancer therapy for mCRPC. Prior lines must include:

  1. At least 1 ARPI
  2. A PARP inhibitor for participants with known BRCA mutation per local practice, unless ineligible per Investigator decision.
  3. A checkpoint inhibitor for participants with known MSI-H, dMMR, or TMB ≥ 10 mut/Mb.
  4. No previous cytotoxic chemotherapy for CRPC. Taxanes for metastatic hormone sensitive prostate cancer (mHSPC) is acceptable if the last cycle Day 1 was \> 12 months before first study treatment.
  5. Previous treatment with prostate specific membrane antigen radioligand therapy (PSMA-RLT) or Radium-223 is allowed but not required. Participants who have had prior radiation therapy, including therapeutic radiopharmaceuticals, external bean radiation therapy (EBRT), and/or brachytherapy are eligible, subject to satisfying all other inclusion/exclusion criteria. Therapeutic radiopharmaceuticals will be considered a prior line of systemic therapy.

Main Exclusion Criteria:

* Treatment with any radiopharmaceutical within 6 weeks of the first dose of Investigational Medicinal Product (IMP).
* Radiation therapy (RT) or external beam radiation therapy (EBRT) 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
* Diffuse and intense osseous radiotracer uptake on bone scintigraphy or PSMA imaging characteristic of a superscan.
* Chronic corticosteroid use greater than 10 mg prednisone equivalent daily.

Where this trial is running

Palo Alto, California and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Castration-Resistant Prostate CancerDose Escalation StudyMetastatic Prostate CancerRadiopharmaceuticalRadiotheranosticsCastration-Resistant Prostate CancerRadiotherapySix Transmembrane Epithelial Antigen of the Prostate 2
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.