Actively Recruiting
A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
Led by AstraZeneca · Updated on 2026-05-12
136
Participants Needed
16
Research Sites
214 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275.
CONDITIONS
Official Title
A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically confirmed adenocarcinoma of the prostate without strong suspicion of majority neuroendocrine differentiation
- Prior bilateral orchiectomy and/or ongoing androgen-deprivation therapy with castrate level testosterone (< 50 ng/dL or < 1.7 nmol/L)
- At least one metastatic lesion on CT, MRI, or bone scan within 28 days before first investigational drug dose
- Adequate organ function
- For Part A: metastatic prostate cancer stable or progressing
- For Part B: progressing metastatic castration-resistant prostate cancer defined by PSA progression, soft-tissue progression, or bone disease progression
- For Part B Dose Escalation: prior treatment with at least 2 systemic anti-cancer therapies including at least 1 androgen receptor pathway inhibitor, a PARP inhibitor if BRCA mutation positive, and a checkpoint inhibitor if MSI-H, dMMR, or tumor mutational burden ≥ 10 mut/Mb
- For Part B Dose Expansion: prior treatment with at least 1 systemic anti-cancer therapy including at least 1 androgen receptor pathway inhibitor, a PARP inhibitor if BRCA mutation positive unless ineligible, a checkpoint inhibitor if MSI-H, dMMR, or tumor mutational burden ≥ 10 mut/Mb, no prior cytotoxic chemotherapy for CRPC, taxanes allowed if last cycle > 12 months before study, prior PSMA radioligand therapy or Radium-223 allowed
- Prior radiation therapy including radiopharmaceuticals, external beam radiation, or brachytherapy allowed if other criteria met
You will not qualify if you...
- Treatment with any radiopharmaceutical within 6 weeks before first investigational drug dose
- Radiation therapy or external beam radiation within 28 days before first investigational drug dose with unresolved events above Grade 1
- Systemic cytotoxic or investigational therapy within 28 days or 5 half-lives before first investigational drug dose
- Any prior treatment-related adverse events not resolved to Grade 1 or less
- Severe or uncontrolled illnesses or social situations limiting study compliance
- Known or suspected allergies or contraindications to investigational drugs or components
- Clinically relevant proteinuria
- Diffuse and intense bone radiotracer uptake characteristic of a superscan
- Chronic corticosteroid use over 10 mg prednisone equivalent daily
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Research Site
Palo Alto, California, United States, 94304
Not Yet Recruiting
2
Research Site
San Diego, California, United States, 92103
Not Yet Recruiting
3
Research Site
Miami, Florida, United States, 33165
Actively Recruiting
4
Research Site
Tampa, Florida, United States, 33612
Actively Recruiting
5
Research Site
Chicago, Illinois, United States, 60637
Actively Recruiting
6
Research Site
Metairie, Louisiana, United States, 70006
Not Yet Recruiting
7
Research Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
Research Site
Rochester, Minnesota, United States, 55902
Not Yet Recruiting
9
Research Site
Omaha, Nebraska, United States, 68130
Actively Recruiting
10
Research Site
New York, New York, United States, 10032
Not Yet Recruiting
11
Research Site
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
12
Research Site
Portland, Oregon, United States, 97239
Not Yet Recruiting
13
Research Site
East Melbourne, Australia, 3002
Actively Recruiting
14
Research Site
CapeTown, South Africa, 7925
Not Yet Recruiting
15
Research Site
Durban, South Africa, 4013
Withdrawn
16
Research Site
Pretoria, South Africa, 181
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
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