Alphamab Oncology's (9966.HK) Investigational New Drug application for a phase 2 clinical trial of JSKN033 as first-line treatment of advanced cervical cancer has been accepted by the Center for Drug Evaluation of China's National Medical Products Administration.
JSKN033 is the company's proprietary high-concentration subcutaneous co-formulation consisting of HER2 bispecific antibody-drug conjugate (ADC) and PD-L1 immune checkpoint inhibitor.
The proposed phase 2 trial, dubbed JSKN033-202, is designed to evaluate the safety, efficiency and pharmacokinetics (PK)/pharmacodynamics (PD) of JSKN033 in combination with platinum-based chemotherapy, with or without bevacizumab, as first-line treatment for patients with advanced cervical cancer.
Currently, Phase I/II clinical trials of JSKN033 for the treatment of solid tumours are being conducted in China and Australia.
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