RecruitingPhase 2NCT06492005

A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer

A Phase II Clinical Study of Efficacy and Safety of 9MW2821Monotherapy or Combined With PD-1 Inhibitor in Locally Advanced or Metastatic Triple-Negative Breast Cancer


Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Enrollment

160 participants

Start Date

Jul 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a Phase 2, open-label,multicenter study designed to evaluate the efficacy and safety of 9MW2821monotherapy or combined with PD-1 inhibitor in locally advanced or metastatic Triple-Negative Breast Cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called 9MW2821 — alone and in combination with a PD-1 immune checkpoint inhibitor — in people with locally advanced or metastatic triple-negative breast cancer (TNBC), a type of breast cancer that lacks hormone receptors and HER2, making it harder to treat with targeted therapies. **You may be eligible if...** - You are 18 to 75 years old with confirmed locally advanced or metastatic triple-negative breast cancer - Your cancer is not suitable for surgery - You have either tried standard treatments that didn't work, or you have not yet received systemic therapy for advanced disease - Your overall health is good (ECOG 0–1) with adequate organ function **You may NOT be eligible if...** - You have uncontrolled brain metastases - You have active autoimmune disease - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding 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

Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol

DRUGPD-1 inhibitior

Subjects will receive intravenous (IV) infusion of PD-1 inhibitor as per protocol


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06492005


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