A Study of MK-6598 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-6598-001)
1期
已完成
NCT05594043
| 适应症 | Advanced or Metastatic Solid Tumors |
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| 分期 | 1期 |
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| 申办方 | Merck Sharp & Dohme LLC |
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| 状态 | 已完成 |
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| 受试者人数 | 39 人 |
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| 干预(药物) | MK-6598, Pembrolizumab |
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| 开始日期 | 2022年12月21日 |
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| 完成日期 | 2025年5月21日 |
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| 结果公布日 | 2026年7月15日 |
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摘要
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 |
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| 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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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。