A Multicenter, Open-label, Phase 1 Study to Evaluate the Safety and Preliminary Efficacy of SOT201 in Patients With Advanced/Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Number and percentages of participants with treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a Phase 1, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SOT201 as monotherapy for participants aged 18 years or above with advanced unresectable or metastatic solid tumors
During dose escalation, the recommended dose(s) of SOT201 given every 3 weeks (Q3W) will be determined
详细描述
Duration of the study for a participant will include:
Screening period: Up to 21 days before day 1 of cycle 1 (can be prolonged up to 42 days, if required due to fresh biopsy) Treatment Period: enrolled and exposed participants will receive continuous treatment until progressive disease (PD), or an occurrence of an unacceptable AE, a withdrawal of consent, or until other permanent discontinuation criteria described in the protocol are met.
End of treatment will occur within 7 (+7) days after the SOT201 discontinuation, and Follow-up period.
Every 30 (±2) days until 90 (+7) days after the final dose of SOT201, until disease progression, the start of new anticancer therapy, death, or withdrawal of participant's consent, whichever comes first.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SOT201
SOT201 will be administered intravenously once every 21 days
干预措施: SOT201 (Drug)
结局指标
主要结局
Number and percentages of participants with treatment-emergent adverse events (TEAEs)
时间窗: from patient signing the ICF up to 90 (+7) days after the last dose of SOT201, assessed approximately up to 3 years
A TEAE is defined as an AE that started or worsened at or after the start of trial treatment Presence of TEAEs, SAEs, and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Number of participants with dose-limiting toxicities (DLTs)
时间窗: 21 days of Cycle 1 plus 7 days of cycle 2 per cycle
DLTs will be defined using NCI CTCAE version 5.0
次要结局
- Characterization of maximum concentration (Cmax) of SOT201(Time Frame: From Day 1 of Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17.) until cycle 20])
- Characterization of pre-dose concentration (Ctrough) of SOT201(From Day 1 of Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17..) until cycle 20)
- Objective response rate (ORR)(From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years)
- Incidence of anti-drug antibodies (ADAs) against SOT201(Day 1 until 30 (±2) days after the last dose of SOT201)
- Characterization of area under the curve (AUClast, AUCinf, AUCtau) of SOT201(From Day 1 Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17.) until cycle 20)
- Characterization of time to maximum concentration (Tmax) of SOT201(From Day 1 of Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17..) until cycle 20)
- Duration of response (iDoR)(From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years)
- Clinical benefit rate (iCBR)(From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years)
- Progression-free survival (iPFS)(From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years)