Actively Recruiting
A Phase I, First-in-human, Dose Escalation 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
N/A
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and dosing of three drugs—AZD2284, AZD2287, and AZD2275—in patients with metastatic castration-resistant prostate cancer. This first-in-human, Phase I trial aims to understand how these drugs behave in the body and to explore their potential effects in this advanced prostate cancer population. The study is divided into two parts: Part A focuses on imaging and dosing optimization, while Part B focuses on dose escalation and therapeutic evaluation. Participants in Part A receive AZD2287 alone or combined with AZD2275 to find the best dosing approach. In Part B, different doses of AZD2284 are given based on findings from Part A, with several dose levels tested to assess safety and potential effectiveness. Expansion cohorts in Part B further explore the effects of AZD2284 at selected doses. Throughout the study, participants will undergo imaging scans such as SPECT/CT, laboratory tests, and monitoring for side effects and drug levels. Researchers will track adverse events, dose-limiting toxicities, and radiation doses, as well as tumor uptake of the drugs. Longer-term outcomes like prostate-specific antigen response, progression-free survival, and overall survival will be followed for up to five years. The total duration of follow-up varies by study part and dose level.
CONDITIONS
Brief 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...
- Male patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically confirmed prostate adenocarcinoma without majority neuroendocrine differentiation
- Prior bilateral orchiectomy and/or ongoing androgen-deprivation therapy with castrate serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L)
- At least one metastatic lesion on recent CT, MRI, or bone scan obtained within 28 days before first study drug dose
- Adequate organ function
- Part A: metastatic prostate cancer stable or progressing
- Part B: progressing metastatic castration-resistant prostate cancer with documented PSA, soft-tissue, or bone progression
- Part B Dose Escalation: previously treated with at least 2 prior systemic anti-cancer therapies including at least 1 androgen receptor pathway inhibitor, and if applicable, PARP inhibitor or checkpoint inhibitor
- Part B Dose Expansion: previously treated with at least 1 prior systemic anti-cancer therapy including at least 1 androgen receptor pathway inhibitor; prior chemotherapy for castration-resistant prostate cancer not allowed; prior radiation therapies allowed under conditions
You will not qualify if you...
- Treatment with any radiopharmaceutical within 6 weeks before first study drug dose
- Radiation therapy or external beam radiation within 28 days before first study drug dose with unresolved side effects above Grade 1
- Use of systemic cytotoxic or investigational therapy within 28 days or 5 half-lives before first study drug dose
- Prior treatment-related adverse events not resolved to Grade 1 or lower
- Severe or uncontrolled illness unrelated to cancer or social issues limiting study compliance
- Known or suspected allergies to study drugs or their components
- Clinically relevant proteinuria
- Diffuse intense bone scan or PSMA imaging uptake indicating superscan
- Chronic corticosteroid use exceeding 10 mg prednisone equivalent daily
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 days after a dose of AZD2287
Participants receive AZD2287, with or without AZD2275 pre-administration, to identify optimal dosing and biodistribution.
Multiple visits over approximately 8 days
Duration - Up to 84 days of receiving AZD2284
Participants receive escalating doses of AZD2284 along with AZD2287 (± AZD2275 as determined in Part A) to assess safety, tolerability, and efficacy.
Multiple visits during treatment period
Duration - Duration varies based on cohort assignment
Participants receive the determined dose of AZD2284 to further evaluate safety and efficacy.
Multiple visits during treatment period
Duration - Up to 5 years
Participants are monitored for safety, tolerability, and overall survival for up to 5 years after treatment.
Regular follow-up visits over the monitoring period
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
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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