A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody) in Patients With Solid Tumors
Фаза 1/2
Прекращено
NCT05159388
| Заболевание | Solid Tumor |
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| Фаза | Фаза 1/2 |
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| Спонсор | Servier Bio-Innovation LLC |
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| Статус | Прекращено |
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| Участники | 46 участн. |
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| Вмешательство | PRS-344/S095012 |
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| Дата начала | 8.09.2021 |
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| Дата завершения | 1.04.2025 |
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| Публикация результатов | 16.06.2026 |
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Кратко
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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