China-based Alphamab Oncology (HKG: 9966) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase I/II study for its investigational drug, JSKN033.
Design and Objectives of the Upcoming Phase I/II Study
The imminent open, multi-center Phase I/II study is designed to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, and anti-tumor activity of JSKN033 in patients with advanced metastatic malignant tumors. The study aims to determine the maximum tolerated dose and/or recommend the phase II dose for the drug. This trial builds on previous research where the Phase I/II study in Australia demonstrated good safety and encouraging anti-tumor activity of JSKN033 in patients with disease progression after multi-line therapies.
JSKN033: A Pioneering Subcutaneous Co-formulation
JSKN033 is self-described as the world’s first subcutaneous co-formulation consisting of the HER2 bispecific antibody JSKN003 and the PD-L1 monoclonal antibody envafolimab, which is also the world’s first subcutaneous anti-PD-L1 inhibitor. Envafolimab received its marketing approval in China in November 2021, marking a significant milestone for the treatment of certain cancers.
The Potential Impact of JSKN033
The approval to conduct the Phase I/II study in China further validates the potential of JSKN033 as a groundbreaking treatment option for patients with advanced metastatic malignant tumors. The study will provide crucial data on the drug’s performance and pave the way for its potential registration and commercialization in the Chinese market.-Fineline Info & Tech
