A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors
1期
提前终止
NCT03843359
| 适应症 | Neoplasms |
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| 分期 | 1期 |
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| 申办方 | GlaxoSmithKline |
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| 状态 | 提前终止 |
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| 受试者人数 | 97 人 |
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| 干预(药物) | GSK3745417, Dostarlimab |
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| 开始日期 | 2019年3月12日 |
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| 完成日期 | 2024年4月4日 |
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| 结果公布日 | 2026年1月8日 |
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摘要
This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone (Part 1A) or co-administered (Part 2A) with dostarlimab in participants with refractory/relapsed solid tumors. Both parts will consist of a dose escalation phase.
Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W)
Up to 21 Days · Participants
| Part 1A: GSK3745417 0.1 mg (Q1W) | 0 Participants |
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| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | 0 Participants |
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| Part 1A: GSK3745417 0.2 mg (Q1W) | 0 Participants |
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| Part 1A: GSK3745417 0.4 mg (Q1W) | 2 Participants |
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Parts 1A: Number of Participants Achieving DLT Following Administration of GSK3745417 Alone (Q3W)
Up to 29 Days · Participants
| Part 1A: GSK3745417 0.1 mg (Q3W) | 0 Participants |
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| Part 1A: GSK3745417 0.2 mg (Q3W) | 0 Participants |
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Parts 2A: Number of Participants Achieving DLT Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
Up to 29 Days · Participants
| Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab | 0 Participants |
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| Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab | 0 Participants |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。