First-in-Human Study of TAK-280 in Participants With Solid Tumors
Фаза 1/2
Прекращено
NCT05220098
| Заболевание | Unresectable Locally Advanced or Metastatic Cancer |
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| Фаза | Фаза 1/2 |
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| Спонсор | Takeda |
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| Статус | Прекращено |
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| Участники | 69 участн. |
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| Вмешательство | TAK-280 |
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| Дата начала | 21.04.2022 |
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| Дата завершения | 28.07.2025 |
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| Публикация результатов | 7.07.2026 |
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Кратко
The main aim of this study is to find out the safety, tolerability, and effect of TAK- 280 in participants with unresectable, locally advanced or metastatic cancer who have experienced treatment failure or are intolerant to standard therapies. Participants will be treated with TAK-280 for up to 14 treatment cycles. Each treatment cycle will be 28 days. After the last dose of study drug, participants will be followed up for survival every 12 weeks for a total of 48 weeks.
Number of Participants With Dose Limiting Toxicities (DLTs)
Cycle 1 (Cycle length=28 days) · Participants
| TAK-280, Dose A | 0 Participants |
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| TAK-280, Dose B | 0 Participants |
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| TAK-280, Dose C | 0 Participants |
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| TAK-280, Dose D | 2 Participants |
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| TAK-280, Dose E | 0 Participants |
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| TAK-280, Dose F | 1 Participants |
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Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)
From start of study drug administration up to follow-up (up to 37 weeks) · Participants
| TAK-280, Dose A | 2 Participants |
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| TAK-280, Dose B | 1 Participants |
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| TAK-280, Dose C | 3 Participants |
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| TAK-280, Dose D | 5 Participants |
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| TAK-280, Dose E | 5 Participants |
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| TAK-280, Dose F | 5 Participants |
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