NCT06692166

A Study to Evaluate 9MW2821 Versus Treatment of Physician's Choice for Subjects With Recurrent or Metastatic Cervical Cancer

A Randomized, Open-label, Phase 3 Study to Evaluate 9MW2821 vs Treatment of Physician's Choice in Subjects With Recurrent or Metastatic Cervical Cancer Who Progressed on or After Platinum-based Chemotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	9MW2821	1.25mg/kg of 9MW2821 by intravenous infusion on days 1, 8 and 15 of every 28-day cycle
DRUG	Chemotherapy	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

Timeline

• Start date: 2024-09-10
• Primary completion: 2027-12-09
• Completion: 2029-12-31
• First posted: 2024-11-18
• Last updated: 2024-11-22

Locations

2 sites across 1 country: China