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
第2相
完了
NCT05613088
| 対象疾患 | Neoplasms, Ovarian |
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| 相 | 第2相 |
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| スポンサー | Bristol-Myers Squibb |
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| ステータス | 完了 |
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| 参加者数 | 106 名 |
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| 介入（薬剤） | MORAb-202, Paclitaxel, Pegylated Liposomal Doxorubicin (PLD), Topotecan |
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| 開始日 | 2023年2月1日 |
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| 完了日 | 2024年6月17日 |
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| 結果公開日 | 2025年7月3日 |
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概要
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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