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