RecruitingPhase 3NCT06692166

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


Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Enrollment

420 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called 9MW2821 compared to standard chemotherapy in women with cervical cancer that has come back or spread after prior treatment. The drug is designed to specifically attack cancer cells while minimizing harm to healthy tissue. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have cervical cancer that has returned or spread and cannot be cured with surgery or radiation - Your cancer was confirmed by biopsy and is a squamous cell, HPV-related adenocarcinoma, or mixed type - You have received one or two previous chemotherapy treatments (including a platinum-based drug) and your cancer has progressed - You are in good physical health and able to carry out daily activities - Your organs are functioning well enough to receive additional chemotherapy **You may NOT be eligible if...** - You have a rare type of cervical cancer (HPV-independent adenocarcinoma or neuroendocrine) - You have received treatment within the last 3–4 weeks, or certain targeted drugs previously - You have serious heart or brain blood vessel problems in the last 6 months - You have cancer that has spread to the brain - You have moderate-to-severe nerve damage in your hands or feet - You have significant fluid buildup in the lungs, belly, or around the heart Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG9MW2821

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

DRUGChemotherapy

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


Locations(2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Fudan University Shanghai Cancer Center

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT06692166


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