RightFit
RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests [64Cu]Cu-AKY-2519 and/or [225Ac]Ac-AKY-2519 for safety, how they move through the body, and radiation dose. It also checks whether [225Ac]Ac-AKY-2519 fights tumors. It is for adults with prostate cancer that has spread and keeps growing despite very low testosterone, whether or not they have had PLUVICTO.

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™).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, with prostate adenocarcinoma confirmed by a tissue or cell test.
  • Fully active or able to do light work, even if heavy activity is limited.
  • Major organs work well enough for the study.
  • Able to agree to join after learning about the study and follow study rules.
  • If cancer has spread to the brain or spinal cord, it has been treated, is stable, causes no symptoms, and does not need steroid medicines.
  • Testosterone level below 50 ng/dL.
  • Cancer worsened during the most recent treatment, based on scans or PSA, a blood marker for prostate cancer.
  • For Group B: Had at least 2 doses of 177Lu-PSMA-617 (PLUVICTO).

Who can't join

  • Had more than 2 androgen receptor pathway inhibitors (hormone-blocking drugs) or more than 1 taxane chemotherapy treatment for prostate cancer that has spread and resists testosterone-lowering treatment.
  • Had targeted radiation treatment before. Group B is an exception and requires at least 2 prior doses of PLUVICTO.
  • Had treatment aimed at B7-H3, a protein target.
  • Received an experimental drug within the past 28 days.
  • Have poor heart function or serious heart disease.
  • Have another serious health condition that could make it hard to take part or judge treatment side effects.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (6)

CA

FL

KS

MA

MI

NE