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

Study Identifier:
AKY-2519-01
CT.gov Identifier:
NCT07581184
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study Summary

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™) andCohort 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Prostate
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Neal Shore
Status
Will Be Recruiting
Condition(s) Treated at Site
Prostate
Location
START New York (Long Island)
Lake Success, NY, United States, 11042
Investigator
Geraldine O'Sullivan Coyne
Status
Will Be Recruiting
Condition(s) Treated at Site
Prostate