A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer

A Phase II Clinical Study of Efficacy and Safety of 9MW2821Monotherapy or Combined With PD-1 Inhibitor in Locally Advanced or Metastatic Triple-Negative Breast Cancer

A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer (NCT06492005) is a Phase 2 interventional studying Triple-Negative Breast Cancer, sponsored by Mabwell (Shanghai) Bioscience Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Triple-Negative Breast Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 160 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Triple-Negative Breast Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved willing to sign a consent form form. 2. Male or female subjects aged 18 to 75 years (including 18 and 75 years). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Histopathological diagnosed of locally advanced or metastatic triple negative breast cancer. Not suitable for radical therapy. 5. Subjects who have failed standard treatment or naive to systemic antitumor therapy in advanced setting. 6. Subjects must submit tumor tissues for test. 7. Life expectancy of ≥ 12 weeks. 8. Subjects must have measurable disease according to RECIST (version 1.1). 9. your organs (liver, kidneys, etc.) are working well enough based on blood testss. 10. Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy. 11. Subjects are willing to follow study procedures Who Should NOT Join This Trial: 1. Preexisting treatment related toxicity Grade ≥ 2 and Grade ≥ 3 immune related adverse reactions 2. Preexisting peripheral neuropathy Grade ≥ 2. 3. Hemoglobin A1C (HbA1c) ≥ 8%. 4. Has ocular conditions that may increase the risk of corneal epithelium damage. 5. History of ILD or pneumotitis, other severe or uncontrolled disease or cancer that has spread to the brain. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form. 2. Male or female subjects aged 18 to 75 years (including 18 and 75 years). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Histopathological diagnosed of locally advanced or metastatic triple negative breast cancer. Not suitable for radical therapy. 5. Subjects who have failed standard treatment or naive to systemic antitumor therapy in advanced setting. 6. Subjects must submit tumor tissues for test. 7. Life expectancy of ≥ 12 weeks. 8. Subjects must have measurable disease according to RECIST (version 1.1). 9. Adequate organ functions. 10. Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy. 11. Subjects are willing to follow study procedures Exclusion Criteria: 1. Preexisting treatment related toxicity Grade ≥ 2 and Grade ≥ 3 immune related adverse reactions 2. Preexisting peripheral neuropathy Grade ≥ 2. 3. Hemoglobin A1C (HbA1c) ≥ 8%. 4. Has ocular conditions that may increase the risk of corneal epithelium damage. 5. History of ILD or pneumotitis, other severe or uncontrolled disease or central nervous system metastases. 6. Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug (Cohort A). Received immune checkpoint inhibitor or systemic immunosuppressive therapy was administered within 14 days prior to the first study (Cohort B and C). traditional Chinese medicine with anticancer indication within 14 days prior to the first dose of study drug, use of any investigational drug or device within 28 days prior to the first dose of study drug, received treatment of nectin-4 targeted ADC with MMAE payload, any P-glycoprotein (P-gp) inducers/inhibitors or strong CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug, major surgery within 28 days prior to first dose of study drug or any live vaccines within 28 days before first dose of study drug or during the study.. 7. History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 8. Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness. 9. Documented history of pulmonary embolism or clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug 10. Active autoimmune disease requiring systemic treatment within 2 years before the subject's first study medication. 11. History of another malignancy within 3 years before the first dose of study drug. 12. Not suitable to receive study treatment for other conditions as per investigator.

Treatments Being Tested

DRUG

9MW2821

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

DRUG

PD-1 inhibitior

Subjects will receive intravenous (IV) infusion of PD-1 inhibitor as per protocol

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06492005), the sponsor (Mabwell (Shanghai) Bioscience Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06492005 clinical trial studying?

This study is a Phase 2, open-label,multicenter study designed to evaluate the efficacy and safety of 9MW2821monotherapy or combined with PD-1 inhibitor in locally advanced or metastatic Triple-Negative Breast Cancer. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06492005?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06492005?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06492005. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06492005. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.