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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMabwell (Shanghai) Bioscience Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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).

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Histopathological diagnosed of locally advanced or metastatic triple negative breast cancer. Not suitable for radical therapy.

Disqualifiers

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 that may increase the risk of corneal epithelium damage.

Trial design

Treatments tested in this trial

  • 9MW2821
  • PD-1 inhibitior

Treatment groups

160 Participants
are divided into 3 treatment groups