ALPHAMAB-B (09966) announced that the first patient has been dosed in a Phase II clinical study (Study Number: JSKN033-202) evaluating JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab for the first-line treatment of advanced cervical cancer.
JSKN033 is a high-concentration subcutaneous compound formulation consisting of an anti-human epidermal growth factor receptor 2 (HER2) bispecific antibody-drug conjugate (ADC) and a programmed death-ligand 1 (PD-L1) immune checkpoint inhibitor.
JSKN033 possesses several significant differentiated advantages. Its "second-level" subcutaneous administration greatly enhances dosing convenience and patient compliance. Its low hematological toxicity profile makes it one of the few ADCs that can be combined with carboplatin, offering a more flexible and safer treatment option for patients with varying renal function, tolerability, and medication habits.
The combination of JSKN033 with platinum-based agents and bevacizumab is expected to exert multiple synergistic anti-tumor effects, including HER2 ADC-targeted cell killing, immune activation, anti-angiogenesis, and chemotherapy, potentially prolonging disease control time and improving patient survival outcomes.
In early clinical studies, JSKN033 monotherapy has already demonstrated excellent efficacy and manageable safety in patients with previously treated advanced cervical cancer, laying a solid foundation for its first-line combination therapy.
JSKN033-202 is an open-label, multicenter, Phase II clinical study designed to evaluate the safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics of JSKN033 combined with platinum-based chemotherapy with or without bevacizumab as a first-line treatment for patients with advanced cervical cancer.
All patients will receive treatment with JSKN033 combined with cisplatin or carboplatin, with or without bevacizumab. The choice of platinum agent and the decision to combine with bevacizumab will be determined by the investigator based on the patient's specific condition.
The initiation of this study is expected to provide a new, effective, safe, and convenient first-line treatment option for patients with advanced cervical cancer.