A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer

Part of paid clinical trials in Miami, Florida.

Sponsor
Aktis Oncology, Inc.
Study ID
NCT07581184
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • B7H3
  • Castration Resistant Metastatic Prostate Cancer
  • Prostate Cancer
  • mCRPC
  • mCRPC (Metastatic Castration-resistant Prostate Cancer)

Eligibility Criteria

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

Interventions

  • [225Ac]Ac-AKY-2519 (therapeutic) — DRUG
    \[225Ac\]Ac-AKY-2519 Injection
  • [64Cu]Cu-AKY-2519 (imaging) — DRUG
    \[64Cu\]Cu-AKY-2519 Injection

Study Details

This is a Phase 1b, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \[64Cu\]Cu-AKY-2519 and/or \[225Ac\]Ac-AKY-2519, as well as the preliminary anti-tumor activity of \[225Ac\]Ac-AKY-2519 in participants with metastatic castration-resistant prostate cancer (mCRPC) with and without prior exposure to 177Lu-PSMA-617 (PLUVICTO™).

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2032

Study Design

Enrollment
138 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: [225Ac]Ac-AKY-2519

Primary Outcome Measure

Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [225Ac]Ac-AKY-2519 [ Time Frame: Up to 30 days following last administration of [225Ac]Ac-AKY-2519 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Biogenix Molecular, LLCMiamiFlorida33165
Study Coordinator
[email protected]
786-791-1799
BAMF HealthGrand RapidsMichigan49503
Study Coordinator
[email protected]
616-330-2735

Find similar trials in Miami, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Biogenix Molecular, LLC· Miami, FLBAMF Health· Grand Rapids, MI

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