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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 6
研究概览
简要总结
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™).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
[225Ac]Ac-AKY-2519
干预措施: [64Cu]Cu-AKY-2519 (imaging) (Drug)
[225Ac]Ac-AKY-2519
干预措施: [225Ac]Ac-AKY-2519 (therapeutic) (Drug)