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NCT Number: NCT07556848

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

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

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Key information

Conditions

Locally Advanced or Metastatic Triple-negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

9MW2821

Drug

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

Chemotherapy

Drug

Participants will receive investigator's choice of chemotherapy determined prior to randomization from 1 of the 4 allowed regimens as per protocol: eribulin, or vinorelbine or capecitabine or gemcitabine.

Primary outcomes

  1. Overall Survival

    Time frame: Up to approximately 2 years

    Time from the date of randomization until the date of death from any cause

Secondary outcomes

  1. Objective Response Rate per investigator

    Time frame: Up to approximately 2 years

    The percentage of subjects who experience a best response of either CR or PR.

  2. Duration of Response per investigator

    Time frame: Up to approximately 2 years

    Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause.

  3. Time to response per investigator

    Time frame: Up to approximately 2 years

    Time from the date of randomization to the date of CR or PR.

  4. Disease Control Rate per investigator

    Time frame: Up to approximately 2 years

    The percentage of subjects who experience a best response of CR, PR or stable disease (SD).

  5. Progression Free Survival per investigator

    Time frame: Up to approximately 2 years

    Time from the date of first randomization to the earliest date of documented disease progression per radiological evidence or death from any cause.

  6. Incidence of adverse events

    Time frame: Up to approximately 2 years

  7. Incidence of Anti-Drug Antibody (ADA)

    Time frame: Up to approximately 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Zhang

CONTACT

[email protected]

021-64175590

Jiong Wu

CONTACT

[email protected]

021-64175590

Sponsors and collaborators

Lead sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Phase 3 Study to Evaluate 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 29, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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