A Study of MK-6598 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-6598-001)
Фаза 1
Завершено
NCT05594043
| Заболевание | Advanced or Metastatic Solid Tumors |
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| Фаза | Фаза 1 |
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| Спонсор | Merck Sharp & Dohme LLC |
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| Статус | Завершено |
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| Участники | 39 участн. |
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| Вмешательство | MK-6598, Pembrolizumab |
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| Дата начала | 21.12.2022 |
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| Дата завершения | 21.05.2025 |
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| Публикация результатов | 15.07.2026 |
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Кратко
The purpose of this study is to assess the efficacy and safety and establish a preliminary recommended Phase 2 dose (RP2D) of MK-6598 administered as monotherapy and in combination with pembrolizumab (MK-3475) in adult participants with advanced or metastatic solid tumors.
Number of Participants With a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 5.0
Up to approximately 21 days · Participants
| 50 mg MK-6598 | 0 Participants |
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| 125 mg MK-6598 | 0 Participants |
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| 250 mg MK-6598 | 0 Participants |
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| 500 mg MK-6598 | 0 Participants |
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| 50 mg MK-6598 + Pembrolizumab | 1 Participants |
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| 125 mg MK-6598 + Pembrolizumab | 0 Participants |
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Number of Participants Who Experienced At Least One AE
Up to approximately 24 months · Participants
| 50 mg MK-6598 | 4 Participants |
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| 125 mg MK-6598 | 3 Participants |
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| 250 mg MK-6598 | 3 Participants |
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| 500 mg MK-6598 | 9 Participants |
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| 50 mg MK-6598 + Pembrolizumab | 7 Participants |
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| 125 mg MK-6598 + Pembrolizumab | 6 Participants |
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Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 24 months · Participants
| 50 mg MK-6598 | 0 Participants |
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| 125 mg MK-6598 | 1 Participants |
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| 250 mg MK-6598 | 0 Participants |
|---|
| 500 mg MK-6598 | 1 Participants |
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| 50 mg MK-6598 + Pembrolizumab | 0 Participants |
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| 125 mg MK-6598 + Pembrolizumab | 1 Participants |
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