AKY-2519 (B7‑H3 targeted radioligand) for metastatic castration‑resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1b, open‑label, multicenter study gives participants a diagnostic imaging dose ([64Cu]Cu‑AKY‑2519) and/or escalating therapeutic doses of an alpha emitter ([225Ac]Ac‑AKY‑2519) to measure safety, tolerability, dosimetry, and pharmacokinetics and to look for early signs of anti‑tumor activity. The trial enrolls two parallel cohorts: Cohort A without prior 177Lu‑PSMA‑617 exposure and Cohort B with prior 177Lu‑PSMA‑617 exposure, with a dose‑escalation stage followed by a backfill stage at selected dose levels. Investigators will collect imaging, laboratory, and clinical response data and use those results to recommend phase 2 dose(s) for each cohort. The primary focus is safety and dose finding; efficacy is evaluated as a secondary, preliminary outcome.

Why it matters

Who can join: the full rules

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

Where it's running

• Hoag Memorial Hospital Presbyterian
  Irvine, California, United States Recruiting
• Biogenix Molecular, LLC
  Miami, Florida, United States Recruiting
• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting
• East Jefferson General Hospital - LCMC Health
  Metairie, Louisiana, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• BAMF Health
  Grand Rapids, Michigan, United States Recruiting

Study contacts

• Study coordinator: Janet Horton, MD, MHSc
• Email: AKY-2519-01inquiries@aktisoncology.com
• Phone: +1-857-216-8482

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519

  This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.

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• FX-111 safety and pharmacokinetics in metastatic castration-resistant prostate cancer

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• Lutetium-177 Ludotadipep for advanced prostate cancer

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• Lower-dose ARPI therapy for metastatic prostate cancer

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• SHR-1701 plus focused stereotactic radiation for metastatic castration‑resistant prostate cancer

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• KTX-2001 (alone and with darolutamide) for men with metastatic castration‑resistant prostate cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.