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A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer (BActinium-1)

14. september 2026 opdateret af: Aktis Oncology, Inc.

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™).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

138

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Irvine, California, Forenede Stater, 92618
        • Rekruttering
        • Hoag Memorial Hospital Presbyterian
        • Kontakt:
    • Florida
      • Miami, Florida, Forenede Stater, 33165
        • Rekruttering
        • Biogenix Molecular, LLC
        • Kontakt:
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66103
        • Rekruttering
        • University of Kansas Medical Center
        • Kontakt:
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
    • Michigan
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68130
        • Rekruttering
        • XCancer
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: [225Ac]Ac-AKY-2519
Medicin: [225Ac]Ac-AKY-2519 (therapeutic)
[225Ac]Ac-AKY-2519 Injection
Medicin: [64Cu]Cu-AKY-2519 (imaging)
[64Cu]Cu-AKY-2519 Injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [225Ac]Ac-AKY-2519
Tidsramme: Up to 30 days following last administration of [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
Tidsramme: From first administration of [225Ac]Ac-AKY-2519 to the end of Cycle 1 (each cycle is 28 days)
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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [64Cu]Cu-AKY-2519
Tidsramme: Up to 30 days following last administration of [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.
Up to 30 days following last administration of [64Cu]Cu-AKY-2519
Objective Response Rate (ORR)
Tidsramme: Up to 30 days following last administration of [225Ac]Ac-AKY-2519
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.
Up to 30 days following last administration of [225Ac]Ac-AKY-2519
Duration of Response (DoR)
Tidsramme: Up to 5 years after first administration
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.
Up to 5 years after first administration
Progression-Free Survival (PFS)
Tidsramme: Up to 5 years after first administration
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.
Up to 5 years after first administration
Prostate Specific Antigen (PSA) >= 50% Response Rate (PSA50)
Tidsramme: Up to 30 days following last administration of [225Ac]Ac-AKY-2519
Will assess PSA decline of >= 50% from baseline (PSA50), using the Prostate Cancer Working Group 3 (PCWG3) criteria.
Up to 30 days following last administration of [225Ac]Ac-AKY-2519
Prostate Specific Antigen (PSA) >= 90% Response Rate (PSA90)
Tidsramme: Up to 30 days following last administration of [225Ac]Ac-AKY-2519
Will assess PSA decline of >= 90% from baseline (PSA90), using the Prostate Cancer Working Group 3 (PCWG3) criteria.
Up to 30 days following last administration of [225Ac]Ac-AKY-2519

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Aktis Oncology, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. juni 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. juni 2032

Datoer for studieregistrering

Først indsendt

6. maj 2026

Først indsendt, der opfyldte QC-kriterier

6. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AKY-2519-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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