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
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.

• Female subjects aged 18 to 75 years (including 18 and 75 years).

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Histologically confirmed recurrent or metastatic cervical cancer (squamous cell, HPV-associated adenocarcinoma, or adenosquamous), not amenable to resection or chemoradiation with curative intent.

• Subject must have received a platinum-based chemotherapy with or without bevacizumab and received no more than 2 prior systemic therapy in the metastatic/recurrent setting. Subject must have experienced radiographic progression during or after the last treatment regimen.

• An archival tumor tissue sample or a fresh tissue sample should be provided.

• Life expectancy of ≥ 12 weeks.

• Subjects must have measurable disease according to RECIST (version 1.1).

• Adequate to receive one of the chemotherapy regimens in the control group (gemcitabine, pemetrexed, topotecan);

⁃ Adequate organ functions.

⁃ Sexually active fertile subjects must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.

⁃ Subjects are willing to follow study procedures.

Locations
Other Locations
China
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Lingying Wu, Professor
wulingying@csco.org.cn
+8601067781331
Backup
Huijuan Yang, Professor
huijuanyang@hotmail.com
+8602164175590
Time Frame
Start Date: 2024-09-10
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 420
Treatments
Experimental: 9MW2821
Active_comparator: Treatment of Physician's Choice
Related Therapeutic Areas
Sponsors
Leads: Mabwell (Shanghai) Bioscience Co., Ltd.

This content was sourced from clinicaltrials.gov

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