A Study of TAK-103 in Adult With Solid Tumors
1期
提前终止
NCT05164666
| 适应症 | Solid Tumors |
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| 分期 | 1期 |
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| 申办方 | Takeda |
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| 状态 | 提前终止 |
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| 受试者人数 | 2 人 |
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| 干预(药物) | TAK-103 |
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| 开始日期 | 2022年1月5日 |
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| 完成日期 | 2025年2月22日 |
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| 结果公布日 | 2026年7月7日 |
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摘要
In this study, people with mesothelin-expressing advanced or metastatic solid tumors will receive TAK-103 with their white blood cells. The main aims of this study are to check if the participants get any side effects from treatment with TAK-103 and to check how much TAK-103 participants can receive without getting side effects from it. Researchers can then work out the best dose of TAK-103 to give to participants in future studies. At the first visit, the study doctor will check who can take part. For those who can take part, the study doctors will collect white blood cells from each participant. These cells are sent to the laboratory where TAK-103 is added to each participant's cells. This can take up to 4 or 5 weeks. Participants may receive specific treatments while participants are waiting for TAK-103. Then, participants will receive TAK-103 with their cells slowly through a vein (infusion). Participants will receive lower to higher doses of TAK-103. Each participant will just receive 1 dose. The study doctors will check for side effects after each different dose of TAK-103. In this way, researchers can work out the best dose of TAK-103 to give to participants in future studie
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Up to 28 days · percentage of participants
| TAK-103, Cohort -2 | 100.0 percentage of participants |
|---|
| TAK-103, Cohort 1 | 100.0 percentage of participants |
|---|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
From first dose of study drug administration up to 24 months · percentage of participants
| TAK-103, Cohort -2 | 100.0 percentage of participants |
|---|
| TAK-103, Cohort 1 | 100.0 percentage of participants |
|---|
Percentage of Participants With Adverse Events of Clinical Interest (AECIs)
From first dose of study drug administration up to 24 months · percentage of participants
| TAK-103, Cohort -2 | 0 percentage of participants |
|---|
| TAK-103, Cohort 1 | 0 percentage of participants |
|---|
| TAK-103, Cohort -2 | 0 percentage of participants |
|---|
| TAK-103, Cohort 1 | 100.0 percentage of participants |
|---|
| TAK-103, Cohort -2 | 0 percentage of participants |
|---|
| TAK-103, Cohort 1 | 0 percentage of 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。