26 Dec 2024: IND application for a phase I/II clinical study of anti-HER2 bispecific ADC subcutaneous co-formulation JSKN033 was approved
Alphamab Oncology has received approval from the CDE of the NMPA for a Phase I/II clinical trial (JSKN033-102) of JSKN033, a high-concentration subcutaneous co-formulation combining immunotherapy (KN035) and ADC (JSKN003)
The JSKN033-102 study is an open-label, multicenter trial aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of JSKN033 in patients with advanced metastatic tumors
This innovative formulation aims to improve safety and convenience by making ADC subcutaneously injectable, leveraging the superior solubility and stability of Envaforlimab, the first subcutaneous PD-L1 inhibitor
The first-in-human Phase I/II study of JSKN033 in Australia (JSKN033-101) showed a favorable safety profile and promising anti-cancer activity in heavily treated patients. At the 2024 SITC Annual Meeting, data revealed that of the ten evaluable patients, three had a partial response (PR) and five had stable disease (SD), resulting in an 80% disease control rate (DCR)
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