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

NCT07556848 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 9MW2821-CP305
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Locally Advanced or Metastatic Triple-negative Breast Cancer

Keywords

triple-negative breast cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

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

  Up to approximately 2 years

Secondary Outcomes (7)

• Objective Response Rate per investigator

  Up to approximately 2 years

• Duration of Response per investigator

  Up to approximately 2 years

• Time to response per investigator

  Up to approximately 2 years

• Disease Control Rate per investigator

  Up to approximately 2 years

• Progression Free Survival per investigator

  Up to approximately 2 years

Study Arms (2)

Experimental: 9MW2821

EXPERIMENTAL

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

Drug: 9MW2821

Active Comparator: Investigator's Choice of Chemotherapy

ACTIVE COMPARATOR

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.

Drug: Chemotherapy

Interventions

9MW2821 DRUG

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

Experimental: 9MW2821

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.

Active Comparator: Investigator's Choice of Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Jiong Wu

CONTACT

021-64175590; wujiong1122@vip.sina.com

Jian Zhang

CONTACT

021-64175590; syner2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)