Status:
RECRUITING
A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Metastatic Castration-Resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275.
Detailed Description
This is a first-in-human, Phase I, non-randomized, open-label clinical trial designed to evaluate AZD2284, AZD2287, and AZD2275. This trial will consist of 2 Parts: Part A (Imaging): * Part A (Cold...
Eligibility Criteria
Inclusion
- Main
- 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
- Main
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
Key Trial Info
Start Date :
March 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 16 2029
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT06879041
Start Date
March 10 2025
End Date
April 16 2029
Last Update
July 23 2025
Active Locations (11)
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1
Research Site
Miami, Florida, United States, 33165
2
Research Site
Chicago, Illinois, United States, 60637
3
Research Site
Boston, Massachusetts, United States, 02215
4
Research Site
Omaha, Nebraska, United States, 68130