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

NCT07581184 | Recruiting Phase 1 FDA Drug

• 1 other identifier: AKY-2519-01
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [225Ac]Ac-AKY-2519

  An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE and the number of patients experiencing an SAE will be reported. Up to 30 days following last administration of \[225Ac\]Ac-AKY-2519

  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

  Dose-limiting toxicities (DLTs) is defined as any predefined AE occurring during the DLT observation period, except those that are clearly and incontrovertibly due to extraneous circumstances. The number of patients who experience a DLT will be reported separately for each cohort and by dose level within each cohort.

  From first administration of [225Ac]Ac-AKY-2519 to the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (6)

• Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [64Cu]Cu-AKY-2519

  Up to 30 days following last administration of [64Cu]Cu-AKY-2519

• Objective Response Rate (ORR)

  Up to 30 days following last administration of [225Ac]Ac-AKY-2519

• Duration of Response (DoR)

  Up to 5 years after first administration

• Progression-Free Survival (PFS)

  Up to 5 years after first administration

• Prostate Specific Antigen (PSA) >= 50% Response Rate (PSA50)

  Up to 30 days following last administration of [225Ac]Ac-AKY-2519

Study Arms (1)

[225Ac]Ac-AKY-2519

EXPERIMENTAL

Drug: [225Ac]Ac-AKY-2519 (therapeutic); Drug: [64Cu]Cu-AKY-2519 (imaging)

Interventions

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

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

[225Ac]Ac-AKY-2519

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

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

[225Ac]Ac-AKY-2519

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aktis Oncology, Inc.: lead

Study Sites (2)

Biogenix Molecular, LLC

Miami, Florida, 33165, United States

RECRUITING

BAMF Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Therapeutics; X-Rays

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Central Study Contacts

Tiffany Wang, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2032
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

US (2)