A Phase I Study of [225Ac]-AZD2284 in Patients with Metastatic Castration-Resistant Prostate Cancer
Study identifier:D7580C00001
ClinicalTrials.gov identifier:NCT06879041
EudraCT identifier:N/A
CTIS identifier:N/A
Recruiting
Official Title
A Phase I, First-in-human, Dose Escalation Study Of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
Medical condition
metastatic castration-resistant prostate cancer
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD2287, AZD2275, AZD2284
Sex
Male
Estimated Enrollment
134
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 10 Mar 2025
Estimated Primary Completion Date: 16 Apr 2029
Estimated Study Completion Date: 16 Apr 2029
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| 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. |
