A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer

Part of paid clinical trials in Palo Alto, California.

Sponsor
AstraZeneca
Study ID
NCT06879041
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD2287 — DRUG
    Participants will receive AZD2287
  • AZD2275 — DRUG
    Participants will receive AZD2275
  • AZD2284 — DRUG
    Participants will receive AZD2284

Study Details

The main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275.

Key Dates

Start date
Mar 10, 2025
Status verified
May 2026
Primary completion
Apr 16, 2029
Completion
Apr 16, 2029

Study Design

Enrollment
136 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Cohort A1: AZD2287 (Hot only)
    Participants will receive AZD2287. If eligible for treatment, will receive dose level (DL)1 of AZD2284.
  • Experimental: Part A: Cohort A2: AZD2275 + AZD2287 (Cold +Hot)
    Participants will receive DL1 of AZD2275 followed by AZD2287. If eligible for treatment, will receive DL1 of AZD2284.
  • Experimental: Part A: Cohort A3: AZD2275 + AZD2287 (Cold +Hot)
    Participants will receive DL2 of AZD2275 followed by AZD2287. If eligible for treatment, will receive DL1 of AZD2284.
  • Experimental: Part B (Actinium-225 Dose Escalation): DL1: AZD2284
    Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL1 of AZD2284.
  • Experimental: Part B (Actinium-225 Dose Escalation): DL2: AZD2284
    Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL2 of AZD2284.
  • Experimental: Part B (Actinium-225 Dose Escalation): DL3: AZD2284
    Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL3 of AZD2284.
  • Experimental: Part B (Actinium-225 Dose Escalation): DL4: AZD2284
    Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL4 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.

Primary Outcome Measure

Number of participants with adverse event (AEs) [ Time Frame: Part A: Up to Day 28; Part B: Up to 5 years ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Research SitePalo AltoCalifornia94304-
Research SiteSan DiegoCalifornia92103-
Research SiteMiamiFlorida33165-
Research SiteTampaFlorida33612-
Research SiteChicagoIllinois60637-
Research SiteMetairieLouisiana70006-
Research SiteBostonMassachusetts02215-
Research SiteRochesterMinnesota55902-
Research SiteOmahaNebraska68130-
Research SiteNew YorkNew York10032-
Research SiteClevelandOhio44195-
Research SitePortlandOregon97239-

Find similar trials in Palo Alto, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Research Site· Palo Alto, CAResearch Site· San Diego, CAResearch Site· Miami, FLResearch Site· Tampa, FLResearch Site· Chicago, ILResearch Site· Metairie, LA

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