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Castration Resistant Metastatic Prostate CancerPhase 1BActinium-1NCT07581184

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

A Phase 1 study testing [225Ac]Ac-AKY-2519 (therapeutic) and [64Cu]Cu-AKY-2519 (imaging) in people with Castration Resistant Metastatic Prostate Cancer and Prostate Cancer, run by Aktis Oncology, Inc. at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
[225Ac]Ac-AKY-2519 (therapeutic) and [64Cu]Cu-AKY-2519 (imaging)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
8 sitesUnited States
Study dates
17 Jun 2026to Jun 2032
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Janet Horton, MD, MHSc contact

+1-857-216-8482

AKY-2519-01inquiries@aktisoncology.com

8 sites in 1 country

United States8 sites, 8 recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Praful Ravi, 617-632-6328, Praful_Ravi@DFCI.HARVARD.EDU

    Recruiting

  • BAMF Health

    Grand Rapids, Michigan, 49503

    Study Coordinator, 616-330-2735, ResearchClinicalTeam@bamfhealth.com

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Irvine, California, 92618

    Gary Ulaner, 949-557-0285, gary.ulaner@hoag.org

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66103

    Study Coordinator, 913-945-7552, CTNurseNav@kumc.edu

    Recruiting

  • East Jefferson General Hospital - LCMC Health

    Metairie, Louisiana, 70006

    Study Coordinator, 504-503-6191, jennifer.schwartz@lcmchealth.org

    Recruiting

  • Biogenix Molecular, LLC

    Miami, Florida, 33165

    Study Coordinator, 786-791-1799, jjoseph@cira-health.com

    Recruiting

  • XCancer

    Omaha, Nebraska, 68130

    Tony Romero, 402-697-2229, tony@xcancer.com

    Recruiting

  • UPMC

    Pittsburgh, Pennsylvania, 15232

    Ravi Patel, MD, 412-623-6720, patelr20@upmc.edu

    412-623-6720

    Recruiting

Other trials in United States

About this study

Official title: BActinium-1: A Phase 1b, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Intravenous Administration of B7-H3 Radiopharmaceutical ([225Ac]Ac-AKY-2519) in Metastatic Castration-Resistant Prostate Cancer

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™).

Read the detailed description

This Phase 1b study consists of a dose escalation portion and a backfill portion. The dose escalation portion will investigate ascending doses of [225Ac]Ac-AKY-2519 across two cohorts enrolling in parallel:

  • Cohort A: participants with metastatic castration-resistant prostate cancer (mCRPC) with NO prior exposure to 177Lu-PSMA-617 (PLUVICTO™) and
  • Cohort B: participants with metastatic castration-resistant prostate cancer (mCRPC) with prior exposure to 177Lu-PSMA-617 (PLUVICTO™)

The backfill portion may enrich in two select dose levels from each cohort (Cohort A: mCRPC 177Lu-PSMA-617 (PLUVICTO™)-naïve; Cohort B: mCRPC 177Lu-PSMA-617 (PLUVICTO™)-experienced) to gather further information on the safety and efficacy and to determine the recommended phase 2 dose (RP2D) for each cohort.

Being tested
[225Ac]Ac-AKY-2519 (therapeutic), [64Cu]Cu-AKY-2519 (imaging)
Keywords
AKY-2519, BActinium-1, AKY-2519-01, B7-H3
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    [225Ac]Ac-AKY-2519 Injection

  • [64Cu]Cu-AKY-2519 (imaging)Drug

    [64Cu]Cu-AKY-2519 Injection

Study groups in NCT07581184
Study groupRoleWhat they receive
[225Ac]Ac-AKY-2519ExperimentalNot described
Receives: Drug: [225Ac]Ac-AKY-2519 (therapeutic); Drug: [64Cu]Cu-AKY-2519 (imaging)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

Secondary outcomes (6)

  1. Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [64Cu]Cu-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 will be reported.

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

  2. Objective Response Rate (ORR)

    ORR is defined as the percentage of patients who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator based on PCWG3-modified RECIST v1.1.

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

  3. Duration of Response (DoR)

    Duration of Response (DoR) is defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause.

    Measured: Up to 5 years after first administration

  4. Progression-Free Survival (PFS)

    PFS is defined as the time from treatment initiation to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.

    Measured: Up to 5 years after first administration

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

    Will assess PSA decline of >= 50% from baseline (PSA50), using the Prostate Cancer Working Group 3 (PCWG3) criteria.

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

  6. Prostate Specific Antigen (PSA) >= 90% Response Rate (PSA90)

    Will assess PSA decline of >= 90% from baseline (PSA90), using the Prostate Cancer Working Group 3 (PCWG3) criteria.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2026
  2. Study start17 Jun 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionJun 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07581184
Sponsor's protocol ID
AKY-2519-01
Acronym
BActinium-1
Status last verified
Oct 2026
First submitted
6 May 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [225Ac]Ac-AKY-2519 (therapeutic) and [64Cu]Cu-AKY-2519 (imaging) in people with Castration Resistant Metastatic Prostate Cancer and Prostate Cancer, run by Aktis Oncology, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Janet Horton, MD, MHSc (+1-857-216-8482, AKY-2519-01inquiries@aktisoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07581184.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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