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OncoMatch/Clinical Trials/NCT06492005

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

Is NCT06492005 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including 9MW2821 and PD-1 inhibitior for triple-negative breast cancer.

Phase 2RecruitingMabwell (Shanghai) Bioscience Co., Ltd.NCT06492005Data as of Jun 2026Location: China

Treatment: 9MW2821 · PD-1 inhibitiorThis 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.

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Extracted eligibility criteria

Treatments studied

Other

9MW2821PD-1 inhibitior

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

Cannot have received: chemotherapy

Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug (Cohort A)

Cannot have received: radiation therapy

Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug (Cohort A)

Cannot have received: immune checkpoint inhibitor

Received immune checkpoint inhibitor or systemic immunosuppressive therapy was administered within 14 days prior to the first study (Cohort B and C)

Cannot have received: systemic immunosuppressive therapy

Received immune checkpoint inhibitor or systemic immunosuppressive therapy was administered within 14 days prior to the first study (Cohort B and C)

Cannot have received: traditional Chinese medicine with anticancer indication

traditional Chinese medicine with anticancer indication within 14 days prior to the first dose of study drug

Cannot have received: investigational drug or device

use of any investigational drug or device within 28 days prior to the first dose of study drug

Cannot have received: nectin-4 targeted ADC with MMAE payload

received treatment of nectin-4 targeted ADC with MMAE payload

Cannot have received: P-glycoprotein (P-gp) inducers/inhibitors

any P-glycoprotein (P-gp) inducers/inhibitors or strong CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug

Cannot have received: strong CYP3A4 inducers/inhibitors

any P-glycoprotein (P-gp) inducers/inhibitors or strong CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug

Cannot have received: major surgery

major surgery within 28 days prior to first dose of study drug

Cannot have received: live vaccines

any live vaccines within 28 days before first dose of study drug or during the study

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06492005 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior chemotherapy, radiation therapy, immune checkpoint inhibitor disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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