A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors
1/2期
进行中（已停止招募）
NCT06390995
| 适应症 | Ovarian Cancer, Solid Tumors |
|---|
| 分期 | 1/2期 |
|---|
| 申办方 | Takeda |
|---|
| 状态 | 进行中（已停止招募） |
|---|
| 受试者人数 | 28 人 |
|---|
| 干预（药物） | TAK-853 |
|---|
| 开始日期 | 2024年5月20日 |
|---|
| 完成日期 | 2025年4月16日 |
|---|
| 结果公布日 | 2026年6月16日 |
|---|
摘要
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 |
|---|
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 |
|---|
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 |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
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。