Меню
Идёт набор NCT07581184

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

Фаза I С лечением Castration Resistant Metastatic Prostate Cancer Prostate Cancer mCRPC (Metastatic Castration-resistant Prostate Cancer) mCRPC

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: [225Ac]Ac-AKY-2519 (therapeutic), [64Cu]Cu-AKY-2519 (imaging).
Кому может быть актуально
Состояния в реестре: Castration Resistant Metastatic Prostate Cancer, Prostate Cancer, mCRPC (Metastatic Castration-resistant Prostate Cancer), mCRPC. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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™).

Подробное описание

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.

Вмешательства

  • Препарат [225Ac]Ac-AKY-2519 (therapeutic)
    \[225Ac\]Ac-AKY-2519 Injection
  • Препарат [64Cu]Cu-AKY-2519 (imaging)
    \[64Cu\]Cu-AKY-2519 Injection

Первичные конечные точки

  • Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [225Ac]Ac-AKY-2519 [Срок оценки: 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 [Срок оценки: From first administration of [225Ac]Ac-AKY-2519 to the end of Cycle 1 (each cycle is 28 days)]
Вторичные конечные точки (6)
  • Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [64Cu]Cu-AKY-2519 [Срок оценки: Up to 30 days following last administration of [64Cu]Cu-AKY-2519]
  • Objective Response Rate (ORR) [Срок оценки: Up to 30 days following last administration of [225Ac]Ac-AKY-2519]
  • Duration of Response (DoR) [Срок оценки: Up to 5 years after first administration]
  • Progression-Free Survival (PFS) [Срок оценки: Up to 5 years after first administration]
  • Prostate Specific Antigen (PSA) >= 50% Response Rate (PSA50) [Срок оценки: Up to 30 days following last administration of [225Ac]Ac-AKY-2519]
  • Prostate Specific Antigen (PSA) >= 90% Response Rate (PSA90) [Срок оценки: Up to 30 days following last administration of [225Ac]Ac-AKY-2519]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 4 центра
  • Hoag Memorial Hospital Presbyterian — Irvine
  • Biogenix Molecular, LLC — Miami
  • BAMF Health — Grand Rapids
  • XCancer — Omaha

Идентификаторы

NCT: NCT07581184 · AKY-2519-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗