A Study of MORAb-202 Versus Investigator's Choice Chemotherapy in Female Participants With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
2상
완료
NCT05613088
| 대상 질환 | Neoplasms, Ovarian |
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| 임상 단계 | 2상 |
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| 스폰서 | Bristol-Myers Squibb |
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| 상태 | 완료 |
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| 참여자 수 | 106 명 |
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| 중재(약물) | MORAb-202, Paclitaxel, Pegylated Liposomal Doxorubicin (PLD), Topotecan |
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| 시작일 | 2023년 2월 1일 |
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| 완료일 | 2024년 6월 17일 |
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| 결과 공개일 | 2025년 7월 3일 |
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요약
The purpose of the study is to assess the safety, tolerability, and efficacy of farletuzumab ecteribulin (MORAb-202) and compare it to Investigator's choice (IC) chemotherapy in female participants with platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube cancer.
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
From the date of randomization to the date of first objectively-documented progression or the date of subsequent therapy (Up to approximately 70 weeks) · Percent of participants
| MORAb-202 | 20.0 Percent of participants |
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| Investigator's Choice (IC) Chemotherapy | 13.9 Percent of participants |
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Number of Participants With Treatment-Related Adverse Event (TRAEs) Leading to Discontinuation Within 6 Months From First Dose
From first dose of study medication up to 6 months · Participants
| MORAb-202 | 2 Participants |
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| Investigator's Choice (IC) Chemotherapy | 0 Participants |
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