20 March 2026: Alphamab Oncology announces the first patient dosed in a Phase 3 clinical study for triple-negative breast cancer of TROP2/HER3 bispecific ADC JSKN016
Alphamab Oncology has reached a major clinical milestone, dosing the first patient in its Phase 3 trial (JSKN016-301) of the bispecific ADC JSKN016, marking its transition into pivotal-stage development for triple-negative breast cancer
This progress comes amid a significant unmet need, as TNBC remains one of the most aggressive breast cancer subtypes, with limited treatment options and poor outcomes for patients who relapse after standard chemotherapy
Addressing this unmet need, JSKN016 has been engineered as a TROP2/HER3 bispecific ADC, combining dual-targeting precision with a topoisomerase I inhibitor payload, designed to both block tumor signaling and deliver potent cytotoxic effects directly into cancer cells
Encouragingly, early clinical studies have already demonstrated promising antitumor activity and a favorable safety profile, helping to build confidence as the program now advances into a large-scale, randomized Phase 3 study across ~60 sites in China
With the trial now underway, the focus shifts to evaluating key outcomes like progression-free survival and overall survival, positioning JSKN016 as a potential new standard of care and offering renewed hope for patients battling advanced TNBC