Recruiting
Phase 1

\[64Cu\]Cu-AKY-2519, \[225Ac\]Ac-AKY-2519

Sponsor:

Aktis Oncology, Inc.

Code:

NCT07581184

Conditions

Castration Resistant Metastatic Prostate Cancer

Prostate Cancer

mCRPC (Metastatic Castration-resistant Prostate Cancer)

mCRPC

B7H3

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[225Ac]Ac-AKY-2519 (therapeutic)

[64Cu]Cu-AKY-2519 (imaging)

Study Details

Brief summary:

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™).

Conditions

Castration Resistant Metastatic Prostate Cancer

Prostate Cancer

mCRPC (Metastatic Castration-resistant Prostate Cancer)

mCRPC

B7H3

Study ID

NCT07581184

Start date

Jul, 2026

Status verified date

Jul, 2026

Completion date

Jun, 2032

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18 years
  • Histologic or cytologic confirmation of prostatic adenocarcinoma
  • ECOG Performance Status of 0 or 1
  • Adequate end-organ function
  • Ability to give informed consent and comply with study requirements
  • Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids
  • Castrate levels of serum testosterone (< 50 ng/dL)
  • Documented disease progression on most recent prior line of therapy, either by PSA or imaging-based progression
  • Cohort B: Received 2 or more prior doses of 177Lu-PSMA-617 (PLUVICTO)

Exclusion Criteria:

  • Prior treatment with more than 2 Androgen receptor pathway inhibitors (ARPIs) and/or more than 1 taxane-based therapy in the mCRPC setting
  • Prior treatment with a targeted radiotherapy

o Exception: Cohort B is required to have had at least 2 prior doses of 177Lu-PSMA-617 (PLUVICTO)
  • Prior treatment with a B7-H3 targeted therapy
  • Received an investigational agent within the previous 28 days
  • Impaired cardiac function or clinically significant cardiac disease
  • Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity

Study Design

Enrollment

138 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: [225Ac]Ac-AKY-2519

Interventions

[225Ac]Ac-AKY-2519 (therapeutic)

\[225Ac\]Ac-AKY-2519 Injection

[64Cu]Cu-AKY-2519 (imaging)

\[64Cu\]Cu-AKY-2519 Injection

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 ]
  • Occurrence of dose-limiting toxicity (DLT) in mCRPC participants with and without prior 177Lu-PSMA-617 exposure [ Time Frame: From first administration of [225Ac]Ac-AKY-2519 to the end of Cycle 1 (each cycle is 28 days) ]

Central Contacts and Locations

Central contacts

Tiffany Wang, MD

+1-857-216-8482AKY-2519-01inquiries@aktisoncology.com

Locations

Hoag Memorial Hospital Presbyterian

Recruiting

Irvine, California, United States, 92618

Contacts

Gary Ulaner

949-557-0285gary.ulaner@hoag.org

Biogenix Molecular, LLC

Recruiting

Miami, Florida, United States, 33165

Contacts

Study Coordinator

786-791-1799jjoseph@cira-health.com

BAMF Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Study Coordinator

616-330-2735ResearchClinicalTeam@bamfhealth.com

XCancer

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Tony Romero

402-697-2229tony@xcancer.com

More Information

Sponsor

Aktis Oncology, Inc.

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • AKY-2519
  • BActinium-1
  • AKY-2519-01
  • B7-H3

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Aktis Oncology, Inc. on 2026-07-14.