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The purpose of this study is to compare the efficacy and safety of 9MW2821 and chemotherapy in participants with recurrent or metastatic cervical cancer who progressed on or after platinum-based chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9MW2821 | Experimental |
| |
| Treatment of Physician's Choice | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9MW2821 | Drug | 1.25mg/kg of 9MW2821 by intravenous infusion on days 1, 8 and 15 of every 28-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from the date of randomization until the date of death from any cause. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate per investigator | The percentage of subjects who experience a best response of either CR or PR. | Up to 3 years |
| Disease Control Rate per investigator | The percentage of subjects who experience a best response of CR, PR or stable disease (SD). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality-of-life questionnaire (QLQ-C30) | The EORTC QLQ-C30 is a 30-question instrument designed to assess overall QoL in cancer patients with 15 domains: 1 GHS/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptomatic scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items were scored from 1 ("not at all") to 4 ("very much"), with the exception of items contributing to the GHS/QoL, which were scored from 1 ("very poor") to 7 ("excellent"). Raw scores were linearly transformed so that all transformed scores ranged from 0 to 100. For the overall health status/quality of life scale and the 5 functioning scales, high scores indicated better overall health status/functioning, and negative change from baseline indicated less improvement. For the symptom scales, a high score indicates a high level of symptomatology, while a negative change from baseline indicates improvement in symptoms. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingying Wu, Professor | Contact | +8601067781331 | wulingying@csco.org.cn | |
| Huijuan Yang, Professor | Contact | +8602164175590 | huijuanyang@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40288679 | Derived | Zhang J, Liu R, Wang S, Feng Z, Yang H, Gao S, Li X, Yao X, Chen J, Gong Z, Li Y, Li X, Wang S, Hu C, Liu J, Zhang M, Yuan F, Shi B, Lou H, Zhao P, Qiu F, Guo H, Hu B, Xu D, Huang H, Zhang X, Feng M, Wang X, Li G, Liu D, Chen X, Wang P. Bulumtatug Fuvedotin (BFv, 9MW2821), a next-generation Nectin-4 targeting antibody-drug conjugate, in patients with advanced solid tumors: a first-in-human, open-label, multicenter, phase I/II study. Ann Oncol. 2025 Aug;36(8):934-943. doi: 10.1016/j.annonc.2025.04.009. Epub 2025 Apr 25. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Chemotherapy | Drug | 1.0 or 1.25 mg/m ^2 topotecan by intravenous infusion on days 1 to 5 or 1000 mg/m ^2 gemcitabine by intravenous infusion on days 1 and 8 or 500 mg/m ^2 pemetrexed by intravenous infusion on day 1 of every 21 days |
|
| Up to 3 years |
| Progression Free Survival per investigator | Time from the date of first randomization to the earliest date of documented disease progression per radiological evidence or death from any cause. | Up to 3 years |
| Duration of Response per investigator | Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause. | Up to 3 years |
| Time to response per investigator | Time from the date of randomization to the date of CR or PR. | Up to 3 years |
| Incidence of adverse events | Up to 3 years |
| Incidence of Anti-Drug Antibody (ADA) | Up to 3 years |
| Up to 3 years |
| EORTC Quality of Life Questionnaire Cervical Cancer Module (QLQ-CX24) Total Scores | The EORTC QLQ-CX24 questionnaire is intended for patients with cervical cancer with different disease stages and treatment modalities. The EORTC-QLQ-CX24 questionnaire consists of 24 questions with answers ranging from 1 (not at all) to 4 (very much). Four functional scales and five symptom scales will be calculated using the EORTC QLQ-CX24 Scoring Manual. The 9 scores calculated from the EORTC-QLQ-CX24 questionnaire will be summarized in descriptive statistics by treatment arm. A high score indicates a high level of symptomatology, while a negative change from baseline indicates improvement in symptoms. | Up to 3 years |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
|
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |