ALPHAMAB-B (09966): First Patient Dosed in Phase III Clinical Study of JSKN033 Monotherapy for Cervical Cancer

ALPHAMAB-B (09966) announced that the first patient has been successfully dosed in a Phase III clinical study (Study No.: JSKN033-301) of JSKN033 (a high-concentration subcutaneous injectable combination formulation composed of a human epidermal growth factor receptor 2 (HER2) bispecific antibody-drug conjugate (ADC(s)) and a programmed death-ligand 1 (PD-L1) immune checkpoint inhibitor) as monotherapy for recurrent or metastatic cervical cancer (regardless of HER2 and PD-L1 expression levels) that has failed platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. JSKN033-301 is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of JSKN033 versus investigator's choice of chemotherapy in patients with recurrent or metastatic cervical cancer (regardless of HER2 and PD-L1 expression levels) that has failed platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. The primary study endpoints are progression-free survival and overall survival assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1); secondary study endpoints include other efficacy endpoints assessed by BICR and investigators according to RECIST v1.1, safety, and pharmacokinetic characteristics, among others. As the world's first and only subcutaneous injectable ADC combination formulation to enter registrational clinical studies, JSKN033 can achieve "second-level" administration, greatly improving dosing convenience and patient compliance, while also combining the synergistic advantages of targeted therapy and immunotherapy, and is expected to bring a new "targeted + immune" treatment option to cervical cancer patients. JSKN033 monotherapy has already demonstrated excellent efficacy and manageable safety in cervical cancer patients who have failed standard treatment, and detailed data were presented in a rapid oral presentation at the European Society for Medical Oncology (ESMO) Congress held in October 2026.