Register a trial

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06879041




Registration number
NCT06879041
Ethics application status
Date submitted
11/03/2025
Date registered
25/03/2025

Titles & IDs
Public title
A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
Scientific title
A Phase I, First-in-human, Dose Escalation Study Of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
Secondary ID [1] 0 0
D7580C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-Resistant Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD2287
Treatment: Drugs - AZD2275
Treatment: Drugs - AZD2284

Experimental: Part A: Cohort A1: AZD2287 (Hot only) - Participants will receive 1 dose of AZD2287. If eligible for treatment, will receive low dose of AZD2284.

Experimental: Part A: Cohort A2: AZD2275 + AZD2287 (Cold +Hot) - Participants will receive low dose of AZD2275 followed by 1 dose of AZD2287. If eligible for treatment, will receive low dose of AZD2284.

Experimental: Part A: Cohort A3: AZD2275 + AZD2287 (Cold +Hot) - Participants will receive medium dose of AZD2275 followed by 1 dose of AZD2287. If eligible for treatment, will receive low dose of AZD2284.

Experimental: Part A Expansion: AZD2287 + AZD2275 (Cold + Hot) - Participants will receive dose of AZD2275 determined earlier in the study followed by 1 dose of AZD2287.

Experimental: Part B (Actinium-225 Dose Escalation): low dose: AZD2284 - Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive low dose of AZD2284.

Experimental: Part B (Actinium-225 Dose Escalation): medium dose: AZD2284 - Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive medium dose of AZD2284.

Experimental: Part B (Actinium-225 Dose Escalation): high dose 1: AZD2284 - Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive high dose of AZD2284.

Experimental: Part B (Actinium-225 Dose Escalation): high dose 2: AZD2284 - Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive high dose of AZD2284.

Experimental: Part B: Cohort E1 - Participants will receive dose of AZD2284 determined by the earlier results. Expansion cohort may be opened to further characterize the safety and efficacy of the dose level.

Experimental: Part B: Cohort E2 - Participants will receive dose of AZD2284 determined by the earlier results. Expansion cohort may be opened to further characterize the safety and efficacy of the dose level.


Treatment: Drugs: AZD2287
AZD2287 is administered through intravenous injection.

Treatment: Drugs: AZD2275
AZD2275 is administered through intravenous infusion.

Treatment: Drugs: AZD2284
AZD2284 is administered through intravenous injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse event (AEs)
Timepoint [1] 0 0
Part A: From Screening (Day -28) to Day 28; Part B: Screening (Day -42 to Day -14) up to 5 years
Primary outcome [2] 0 0
Number of participants with Dose Limiting Toxicities (DLTs)
Timepoint [2] 0 0
Part B: Screening (Day -42 to Day -14) up to 2 cycles (84 days) of AZD2284
Primary outcome [3] 0 0
Estimates of residence time
Timepoint [3] 0 0
Part A: Up to Day 8 after dosing with AZD2287 on Day 1
Primary outcome [4] 0 0
Absorbed radiation doses for AZD2287 and AZD2284
Timepoint [4] 0 0
Part A: Up to Day 8 after dosing with AZD2287 on Day 1; Part B: Up to Day 8 after dosing with AZD2287 on Day -14
Primary outcome [5] 0 0
Compare organ uptake of AZD2287 with and without pre-dose administration of AZD2275
Timepoint [5] 0 0
Part A: Up to Day 8 after dosing with AZD2287 on Day 1; Part B: Up to Day 8 after dosing with AZD2287 on Day -14
Primary outcome [6] 0 0
Tumor uptake of AZD2287 in selected regions of interest on SPECT/CT and/or planar images
Timepoint [6] 0 0
Part A: Up to Day 8 after dosing with AZD2287 on Day 1; Part B: Up to Day 8 after dosing with AZD2287 on Day -14
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Up to 12 months after the last dose of AZD2284
Secondary outcome [2] 0 0
Proportion of participants with Prostate-Specific Antigen (PSA) 50
Timepoint [2] 0 0
Up to 12 months after the last dose of AZD2284
Secondary outcome [3] 0 0
Proportion of participants with PSA90
Timepoint [3] 0 0
Up to 12 months after the last dose of AZD2284
Secondary outcome [4] 0 0
Time to maximum PSA % decline
Timepoint [4] 0 0
Up to 12 months after the last dose of AZD2284
Secondary outcome [5] 0 0
Duration of Response (DoR)
Timepoint [5] 0 0
Up to 12 months after the last dose of AZD2284
Secondary outcome [6] 0 0
Radiographic Progression Free Survival (rPFS)
Timepoint [6] 0 0
Up to 12 months after the last dose of AZD2284
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
Part A: Up to Day 28; Part B: Up to 5 years
Secondary outcome [8] 0 0
Pharmacokinetic Clearance
Timepoint [8] 0 0
Part A: Up to Day 28; Part B: Up to Cycle 2 (each cycle is 42 days)
Secondary outcome [9] 0 0
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Timepoint [9] 0 0
Part A: Up to Day 28; Part B: Up to Cycle 2 (each cycle is 42 days)
Secondary outcome [10] 0 0
Maximum observed drug concentration (Cmax)
Timepoint [10] 0 0
Part A: Up to Day 28; Part B: Up to Cycle 2 (each cycle is 42 days)
Secondary outcome [11] 0 0
Half-life (t1/2)
Timepoint [11] 0 0
Part A: Up to Day 28; Part B: Up to Cycle 2 (each cycle is 42 days)
Secondary outcome [12] 0 0
Changes in plasma concentrations of AZD2287 and AZD2284 following AZD2275 pre-administration compared to AZD2287 and AZD2284 alone
Timepoint [12] 0 0
Part A: Up to Day 28; Part B: Up to Cycle 2 (each cycle is 42 days)
Secondary outcome [13] 0 0
Number of participants with positive antidrug antibodies (ADAs)
Timepoint [13] 0 0
Part A dose exploration: Up to Day 28; Part B: Up to End of Trial (approximately 1 year)

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/04/2029
Actual
Sample size
Target
134
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Nebraska
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
South Africa
State/province [6] 0 0
CapeTown
Country [7] 0 0
South Africa
State/province [7] 0 0
Durban
Country [8] 0 0
South Africa
State/province [8] 0 0
Pretoria

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06879041