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
| Registry | NCT07556848 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 356 (Estimated) |
| Sponsor | Mabwell (Shanghai) Bioscience Co., Ltd. (Industry) |
| Conditions | Locally Advanced or Metastatic Triple-negative Breast Cancer |
| Interventions | 9MW2821, Chemotherapy (Drug) |
| Dates | start 2026-05-01 (estimated), primary completion 2027-12-01 (estimated), completion 2028-09-01 (estimated), first posted 2026-04-29, last updated 2026-04-30 |
| Locations | 1 site in China |
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All trials for Locally Advanced or Metastatic Triple-negative Breast Cancer All trials of 9MW2821 All trials of Chemotherapy
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental: 9MW2821 | Experimental | Drug: 9MW2821 | Participants will receive intravenous (IV) infusion of 9MW2821 as per protocol |
| Active Comparator: Investigator's Choice of Chemotherapy | Active comparator | Drug: Chemotherapy | 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. |
Sex: All, ages: 18 Years to 75 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai, Shanghai Municipality | China |