A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT06879041
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
134 participants
INTERVENTIONAL
2025-03-10
2029-04-16
Brief Summary
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Detailed Description
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This trial will consist of 2 Parts:
Part A (Imaging):
* Part A (Cold Antibody Exploration): aims to determine the optimal dosing regimen, with or without unconjugated antibody (AZD2275) pre-administration to improve the biodistribution of AZD2287.
* Part A Expansion: aims to explore the prevalence of PSMA and STEAP2 expression by imaging.
Part B (Therapeutic):
* Part B (Actinium-225 Dose Escalation): aims to assess the safety, tolerability, and efficacy of escalating doses of AZD2284 informed by the optimal dosing regimen identified in Part A.
* Part B Expansion Cohorts 1 and 2: aims to explore efficacy of AZD2284.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: Cohort A1: AZD2287 (Hot only)
Participants will receive 1 dose of AZD2287. If eligible for treatment, will receive low dose of AZD2284.
AZD2287
AZD2287 is administered through intravenous injection.
AZD2284
AZD2284 is administered through intravenous injection.
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.
AZD2287
AZD2287 is administered through intravenous injection.
AZD2275
AZD2275 is administered through intravenous infusion.
AZD2284
AZD2284 is administered through intravenous injection.
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.
AZD2287
AZD2287 is administered through intravenous injection.
AZD2275
AZD2275 is administered through intravenous infusion.
AZD2284
AZD2284 is administered through intravenous injection.
Part A Expansion: AZD2287 + AZD2275 (Cold + Hot)
Participants will receive dose of AZD2275 determined earlier in the study followed by 1 dose of AZD2287.
AZD2287
AZD2287 is administered through intravenous injection.
AZD2275
AZD2275 is administered through intravenous infusion.
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.
AZD2287
AZD2287 is administered through intravenous injection.
AZD2275
AZD2275 is administered through intravenous infusion.
AZD2284
AZD2284 is administered through intravenous injection.
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.
AZD2287
AZD2287 is administered through intravenous injection.
AZD2275
AZD2275 is administered through intravenous infusion.
AZD2284
AZD2284 is administered through intravenous injection.
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.
AZD2287
AZD2287 is administered through intravenous injection.
AZD2275
AZD2275 is administered through intravenous infusion.
AZD2284
AZD2284 is administered through intravenous injection.
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.
AZD2287
AZD2287 is administered through intravenous injection.
AZD2275
AZD2275 is administered through intravenous infusion.
AZD2284
AZD2284 is administered through intravenous injection.
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.
AZD2287
AZD2287 is administered through intravenous injection.
AZD2275
AZD2275 is administered through intravenous infusion.
AZD2284
AZD2284 is administered through intravenous injection.
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.
AZD2287
AZD2287 is administered through intravenous injection.
AZD2275
AZD2275 is administered through intravenous infusion.
AZD2284
AZD2284 is administered through intravenous injection.
Interventions
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AZD2287
AZD2287 is administered through intravenous injection.
AZD2275
AZD2275 is administered through intravenous infusion.
AZD2284
AZD2284 is administered through intravenous injection.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Miami, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Boston, Massachusetts, United States
Research Site
Omaha, Nebraska, United States
Research Site
New York, New York, United States
Research Site
Cleveland, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
East Melbourne, , Australia
Research Site
CapeTown, , South Africa
Research Site
Durban, , South Africa
Research Site
Pretoria, , South Africa
Countries
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Central Contacts
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Other Identifiers
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D7580C00001
Identifier Type: -
Identifier Source: org_study_id
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