A Multicentre, Open-label, Phase I/II Study Investigating the Safety, Tolerability, and Preliminary Efficacy of 225Ac-SSO110 in Participants With Extensive Stage Small Cell Lung Cancer (ES-SCLC) or Merkel Cell Carcinoma (MCC) Receiving Standard of Care (SoC)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 13
- 主要终点
- Part 1: Safety, tolerability, RP2D of 225Ac-SSO110 in combination with SoC
研究概览
简要总结
This study aims to determine safety, tolerability, recommended phase 2 dose (RP2D), and preliminary antitumor activity of 225Ac-SSO110 with standard of care (SoC) therapy in patients with somatostatin receptor 2 expressing (SSTR2+) extensive-stage small cell lung cancer (ES-SCLC) and recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form and willing to comply with all study procedures.
- •Participants with ES-SCLC (defined as Stage IV per NCCN guidelines Version 1.2024) or recurrent locally advanced or metastatic MCC (per NCCN guidelines Version 1.2024) documented by histology or cytology.
- •Participants eligible to receive immune checkpoint inhibitor (CPI) monotherapy at the start of treatment with 225Ac-SSO110 or patients already on CPI monotherapy for 7 weeks.
- •ECOG performance status of 0 or
- •Life expectancy of at least 6 months.
- •Positive 68Ga-SSO120 scan (Investigator-assessed) during screening.
排除标准
- •Participants with unstable spinal cord compression.
- •Any previous systemic radioligand therapy or extensive radiotherapy.
- •Participants receiving or planned to receive consolidative chest radiation.
- •History of primary immunodeficiency, transplantation or CAR-T cell therapy.
- •Major surgical procedure except diagnostic biopsy within 28 days prior to enrolment or scheduled to have major surgery during the study.
- •Inadequate organ or marrow function.
研究组 & 干预措施
225Ac-SSO110 + SoC
干预措施: 225Ac-SSO110 + SoC (Drug)
225Ac-SSO110 + SoC
干预措施: Atezolizumab (Drug)
225Ac-SSO110 + SoC
干预措施: Durvalumab (Drug)
225Ac-SSO110 + SoC
干预措施: Avelumab (Drug)
225Ac-SSO110 + SoC
干预措施: Pembrolizumab (Drug)
225Ac-SSO110 + SoC
干预措施: Retifanlimab (Drug)
结局指标
主要结局
Part 1: Safety, tolerability, RP2D of 225Ac-SSO110 in combination with SoC
时间窗: 42 days
Identification of the DLT rate per dose level
Part 2: Safety, tolerability, and preliminary anti-tumor activity of 225Ac-SSO110 in combination with SoC at RP2D
时间窗: 42 days
Rate of serious adverse events, adverse events, laboratory parameters, and other safety findings, Preliminary anti-tumor activity of 225Ac-SSO110 as assessed by progression free survival (PFS), disease control rate (DCR), best observed response (BOR), overall response rate (ORR), duration of response (DoR)
Part 1 & 2: Safety and tolerability of 68Ga-SSO120
时间窗: 7 days
Rate of serious adverse events, adverse events, laboratory parameters, and other safety findings
次要结局
未报告次要终点