A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody) in Patients With Solid Tumors
1/2期
提前终止
NCT05159388
| 适应症 | Solid Tumor |
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| 分期 | 1/2期 |
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| 申办方 | Servier Bio-Innovation LLC |
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| 状态 | 提前终止 |
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| 受试者人数 | 46 人 |
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| 干预（药物） | PRS-344/S095012 |
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| 开始日期 | 2021年9月8日 |
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| 完成日期 | 2025年4月1日 |
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| 结果公布日 | 2026年6月16日 |
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摘要
This is a first-in-human (FIH), phase 1/2, multi center, open-label, dose escalation and cohort expansion study designed to determine the safety and tolerability of PRS-344/S095012 in patients with advanced and/or metastatic solid tumors.
Safety Measurements: Number of Participants With at Least One DLT in the First 28-days of Treatment
28 days · Participants
| PRS-344/S095012 12mg | 0 Participants |
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| PRS-344/S095012 36mg | 1 Participants |
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| PRS-344/S095012 60mg | 3 Participants |
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| PRS-344/S095012 80mg | 1 Participants |
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| PRS-344/S095012 36mg and Obinutuzumab | 3 Participants |
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Safety Measurements: Number of Participants With at Least One AE
Through study termination, approximately 3.5 years · Participants
| PRS-344/S095012 12mg | 4 Participants |
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| PRS-344/S095012 36mg | 9 Participants |
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| PRS-344/S095012 60mg | 14 Participants |
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| PRS-344/S095012 80mg | 6 Participants |
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| PRS-344/S095012 36mg and Obinutuzumab | 12 Participants |
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Safety Measurements: Number of Participants With at Least One AE Leading to Treatment Discontinuation
Through study termination, approximately 3.5 years · Participants
| PRS-344/S095012 12mg | 1 Participants |
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| PRS-344/S095012 36mg | 4 Participants |
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| PRS-344/S095012 60mg | 7 Participants |
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| PRS-344/S095012 80mg | 2 Participants |
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| PRS-344/S095012 36mg and Obinutuzumab | 7 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。