Locally Advanced or Metastatic Triple-negative Breast Cancer
Investigational drug(s) / intervention(s)
9MW2821Chemotherapy
9MW2821: Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol
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.
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Overall Survival — Up to approximately 2 years Time from the date of randomization until the date of death from any cause
Trial sites (1)
Facility
City
Region
Status
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
More Mabwell (Shanghai) Bioscience Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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