Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has been approved by the NMPA to enter Phase II clinical trial as monotherapy or in combination with a PD-1 inhibitor for the treatment of triple-negative breast cancer (TNBC).
The Phase II clinical trial recently approved aims to evaluate the efficacy and safety of 9MW2821 as monotherapy or in combination with a PD-1 inhibitor in patients with locally advanced or metastatic TNBC. The study includes two cohorts: Cohort A will enroll patients with locally advanced or metastatic TNBC who have previously received taxane/anthracycline-based chemotherapy and topoisomerase inhibitor based antibody-drug conjugate treatment, and will receive 9MW2821 monotherapy; Cohort B will enroll patients with locally advanced or metastatic TNBC who have not previously received systemic therapy, and will receive a combination treatment of 9MW2821 and a PD-1 inhibitor.
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