A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer

Starting soon · Phase 3

Conditions studied: Locally Advanced or Metastatic Triple-negative Breast Cancer

In brief

The purpose of this study is to compare the efficacy and safety of 9MW2821 versus investigator's choice of chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer who have previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload

Key facts

Study ID

NCT07556848

Run by

Mabwell (Shanghai) Bioscience Co., Ltd.

People needed

356

Starts

2026-05-01

Expected to finish

2028-09-01

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
• Male or female subjects aged 18 to 75 years (including 18 and 75 years).
• ECOG 0-1.
• Histopathological diagnosed triple-negative breast cancer.
• Patient has previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload.
• Suitable for one of active comparator chemotherapy assessed by investigator.
• 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 organ functions.
• Sexually active fertile participants, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.

You may not qualify if…

• Preexisting treatment related toxicity Grade ≥ 2 and Grade ≥ 3 immune related adverse reactions.
• Preexisting peripheral neuropathy Grade ≥ 2.
• Hemoglobin A1C (HbA1c) ≥ 8%.
• Has ocular conditions or symptoms that may increase the risk of the study.
• History of ILD or pneumotitis, other severe or uncontrolled disease or central nervous system metastases and/or meningeal metastasis.
• Previous medication does not meet the requirements.
• Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
• Documented history of pulmonary embolism or clinically significant cardiac or cerebrovascular diseases .
• Active autoimmune disease.
• History of another malignancy .
• Pleural, abdominal, or pericardial effusion with clinical symptoms or that require drainage treatment.
• Not suitable to receive study treatment for other conditions as per investigator.

Where it is running

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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