Alphamab Oncology announces the first patient dosed in a phase 3 clinical study for colorectal cancer of biparatopic HER2-targeting ADC JSKN003

CAR-T Digest - August 2020

Weekly Digest - February 2026

14 February 2026: Alphamab Oncology announces the first patient dosed in a phase 3 clinical study for colorectal cancer of biparatopic HER2-targeting ADC JSKN003

Alphamab Oncology announced that the first patient has been dosed in the Phase 3 JSKN003-005 study evaluating its biparatopic HER2-targeting antibody–drug conjugate JSKN003 for the treatment of HER2-positive advanced colorectal cancer
The initiation of this pivotal trial addresses a significant unmet need, as colorectal cancer remains highly prevalent in China, with a large proportion of patients diagnosed at an advanced stage and limited survival outcomes once metastatic as no HER2-targeted therapies are approved in China for colorectal cancer, and patients who have progressed after standard chemotherapy face poor prognosis with short median progression-free and overall survival
Early clinical data for JSKN003 have shown encouraging activity, including a high objective response rate and prolonged median progression-free survival in HER2-positive advanced colorectal cancer, leading to Breakthrough Therapy Designation from China’s Center for Drug Evaluation
The randomized, open-label, multicenter Phase 3 trial will compare JSKN003 against investigator’s choice of approved later-line therapies, with progression-free survival assessed by blinded independent central review as the primary endpoint, alongside overall survival and other key efficacy measures
Dosing of the first patient marks a major development milestone for JSKN003 in colorectal cancer, potentially paving the way for a new HER2-targeted treatment option in a population with limited alternatives