Study identifier:D7580C00001
ClinicalTrials.gov identifier:NCT06879041
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, First-in-human, Dose Escalation Study Of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
metastatic castration-resistant prostate cancer
Phase 1
No
AZD2287, AZD2275, AZD2284
Male
134
Interventional
18 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
PAREXEL
The main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275.
This is a first-in-human, Phase I, non-randomized, open-label clinical trial designed to evaluate AZD2284, AZD2287, and AZD2275. 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.
Location
Status
Location
East Melbourne, Australia, 3002
Status
Not yet recruiting
Location
Omaha, NE, United States, 68130
Status
Recruiting
Location
Durban, South Africa, 4013
Status
Not yet recruiting
Location
Portland, OR, United States, 97239
Status
Not yet recruiting
Location
Chicago, IL, United States, 60637
Status
Not yet recruiting
Location
Boston, MA, United States, 02215
Status
Not yet recruiting
Location
CapeTown, South Africa, 7925
Status
Not yet recruiting
Location
Miami, Florida, United States, 33165
Status
Recruiting
Arms | Assigned Interventions |
---|---|
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. | Drug: AZD2287 AZD2287 is administered through intravenous injection. Drug: AZD2284 AZD2284 is administered through intravenous injection. |
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. | Drug: AZD2287 AZD2287 is administered through intravenous injection. Drug: AZD2275 AZD2275 is administered through intravenous infusion. Drug: AZD2284 AZD2284 is administered through intravenous injection. |
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. | Drug: AZD2287 AZD2287 is administered through intravenous injection. Drug: AZD2275 AZD2275 is administered through intravenous infusion. Drug: AZD2284 AZD2284 is administered through intravenous injection. |
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. | Drug: AZD2287 AZD2287 is administered through intravenous injection. Drug: AZD2275 AZD2275 is administered through intravenous infusion. |
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. | Drug: AZD2287 AZD2287 is administered through intravenous injection. Drug: AZD2275 AZD2275 is administered through intravenous infusion. Drug: AZD2284 AZD2284 is administered through intravenous injection. |
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. | Drug: AZD2287 AZD2287 is administered through intravenous injection. Drug: AZD2275 AZD2275 is administered through intravenous infusion. Drug: AZD2284 AZD2284 is administered through intravenous injection. |
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. | Drug: AZD2287 AZD2287 is administered through intravenous injection. Drug: AZD2275 AZD2275 is administered through intravenous infusion. Drug: AZD2284 AZD2284 is administered through intravenous injection. |
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. | Drug: AZD2287 AZD2287 is administered through intravenous injection. Drug: AZD2275 AZD2275 is administered through intravenous infusion. Drug: AZD2284 AZD2284 is administered through intravenous injection. |
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. | Drug: AZD2287 AZD2287 is administered through intravenous injection. Drug: AZD2275 AZD2275 is administered through intravenous infusion. Drug: AZD2284 AZD2284 is administered through intravenous injection. |
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. | Drug: AZD2287 AZD2287 is administered through intravenous injection. Drug: AZD2275 AZD2275 is administered through intravenous infusion. Drug: AZD2284 AZD2284 is administered through intravenous injection. |
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