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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
17/03/2025

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
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0

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