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

NCT07556848 — Phase 3, Not yet recruiting, 356 participants, Mabwell (Shanghai) Bioscience Co., Ltd.

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT07556848
StatusNot yet recruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment356 (Estimated)
SponsorMabwell (Shanghai) Bioscience Co., Ltd. (Industry)
ConditionsLocally Advanced or Metastatic Triple-negative Breast Cancer
Interventions9MW2821, Chemotherapy (Drug)
Datesstart 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
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Locally Advanced or Metastatic Triple-negative Breast Cancer All trials of 9MW2821 All trials of Chemotherapy

-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

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Experimental: 9MW2821ExperimentalDrug: 9MW2821Participants will receive intravenous (IV) infusion of 9MW2821 as per protocol
Active Comparator: Investigator's Choice of ChemotherapyActive comparatorDrug: ChemotherapyParticipants 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.
  • 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.

+Outcome measures

Primary outcomes

  • Overall Survival [Up to approximately 2 years]: Time from the date of randomization until the date of death from any cause

Secondary outcomes

  • Objective Response Rate per investigator [Up to approximately 2 years]: The percentage of subjects who experience a best response of either CR or PR.
  • Duration of Response per investigator [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.
  • Time to response per investigator [Up to approximately 2 years]: Time from the date of randomization to the date of CR or PR.
  • Disease Control Rate per investigator [Up to approximately 2 years]: The percentage of subjects who experience a best response of CR, PR or stable disease (SD).
  • Progression Free Survival per investigator [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.
  • Incidence of adverse events [Up to approximately 2 years]
  • Incidence of Anti-Drug Antibody (ADA) [Up to approximately 2 years]

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Fudan University Shanghai Cancer CenterShanghai, Shanghai MunicipalityChina