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
Фаза 2
Завершено
NCT05613088
| Заболевание | Neoplasms, Ovarian |
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| Фаза | Фаза 2 |
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| Спонсор | Bristol-Myers Squibb |
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| Статус | Завершено |
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| Участники | 106 участн. |
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| Вмешательство | MORAb-202, Paclitaxel, Pegylated Liposomal Doxorubicin (PLD), Topotecan |
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| Дата начала | 1.02.2023 |
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| Дата завершения | 17.06.2024 |
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| Публикация результатов | 3.07.2025 |
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Кратко
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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