A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors
第1/2相
実施中(募集終了)
NCT06390995
| 対象疾患 | Ovarian Cancer, Solid Tumors |
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| 相 | 第1/2相 |
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| スポンサー | Takeda |
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| ステータス | 実施中(募集終了) |
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| 参加者数 | 28 名 |
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| 介入(薬剤) | TAK-853 |
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| 開始日 | 2024年5月20日 |
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| 完了日 | 2025年4月16日 |
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| 結果公開日 | 2026年6月16日 |
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概要
The main aim of this study are to check for side effects from TAK-853, check how much TAK-853 participants can receive without getting side effects from it, check how well TAK-853 controls symptoms, and to check how much TAK-853 stays in their blood over time. The study will be conducted in two phases including Phase 1 Part and Phase 2 Part. In Phase 1 Part, the participants will stay in the hospital for 3 days at least after their 1st injection for some tests and to check for any side effects from their treatment. In Phase 2 Part, participants will visit their study hospital for multiple times. In both phases, the participants will receive TAK-853 on the first days of each 3-week cycle. The participant will be in the study for about 9 months in Phase 1 Part and for about 24 months in Phase 2 Part. The study doctors will check for side effects from the study treatments.
Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cycle 1
Up to Cycle 1 (up to 21 days) · Participants
| Phase 1: TAK-853, 6 mg/kg | 0 Participants |
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Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
From start of study drug up to 30 days after last dose (up to 3.7 months) · Participants
| Phase 1: TAK-853, 6 mg/kg | 3 Participants |
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Phase 1: Number of Participants With Grade 3 or Higher TEAEs by Severity
From start of study drug up to 30 days after last dose (up to 3.7 months) · Participants
| Phase 1: TAK-853, 6 mg/kg | 2 Participants |
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BENITIONS で見る
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すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。