Zhitong Finance App News, Corning Jerry Pharmaceutical-B (09966) announced the Phase III clinical study of JSKN033 (a high-concentration subcutaneous combination preparation composed of human epidermal growth factor receptor 2 (HER2) bispecific antibody conjugate drug (ADC (s)) and a programmed death ligand 1 (PD-L1) immune checkpoint inhibitor) to treat recurrent or metastatic cervical cancer with platinum-containing chemotherapy and PD-1/PD-L1 inhibitors (regardless of HER2 and PD-L1 expression) Study ID: JSKN033 -301) First patient administration has been successfully completed.
JSKN033-301 is a randomized, controlled, open, multicenter phase III clinical study to evaluate the efficacy and safety of JSKN033 versus investigator-selected chemotherapy in patients with recurrent or metastatic cervical cancer (regardless of HER2 and PD-L1 expression levels) who failed platinum-containing chemotherapy and PD-1/PD-L1 inhibitors. The main study endpoints were progression-free survival and overall survival assessed by the Blind Independent Center Assessment (BICR) according to the Solid Tumor Efficacy Evaluation Criteria (RECIST v1.1); secondary study endpoints included BICR and other efficacy endpoints, safety, and pharmacokinetic characteristics assessed by the researchers according to RECIST v1.1.
As the world's first and only subcutaneous ADC compound formulation to enter registered clinical research, JSKN033 can achieve “seconds-level” administration, greatly improving the convenience of medication use and patient compliance. At the same time, it also has the synergy between targeted therapy and immunotherapy, and is expected to bring a new “target+immunity” treatment plan to cervical cancer patients. The JSKN033 single drug has shown excellent efficacy and controllable safety in cervical cancer patients who have failed standard treatment. Detailed data was presented in the form of a quick oral report at the European Society of Medical Oncology (ESMO) conference held in October 2026.