ALPHAMAB-B(09966): The latest research results of JSKN016 will be presented at the 2026 ASCO annual meeting.

ALPHAMAB-B(09966) announced the latest research results of the Phase I clinical study (Study Code: JSKN016-101) of JSKN016 (an ADC targeting TROP2 and HER3) for the treatment of HER2- locally advanced or metastatic breast cancer, which were presented during the poster session at the 2026 ASCO Annual Meeting held from May 29 to June 2, 2026. JSKN016-101 (NCT06592417) is an open-label, multicenter Phase I clinical study conducted in late-stage malignant solid tumor patients in China. The study consists of two stages: dose escalation and dose expansion, aimed at assessing the safety, tolerability, pharmacokinetics/pharmacodynamics, and anti-tumor activity of JSKN016 and determining the MTD and/or RP2D. The dose escalation stage explored six dose levels of 0.5, 1, 2, 4, 6, and 8 mg/kg, administered Q3W. None of the explored doses reached the MTD, and the RP2D for BC patients was determined to be 6 mg/kg Q3W. JSKN016 demonstrated potent anti-tumor activity and excellent safety in HER2- refractory BC patients, with the dual-target design providing significant efficacy enhancement and the use of glycoconjugation technology maximizing the reduction of adverse reactions, resulting in a unique safety advantage. These research results have laid a solid foundation for exploring JSKN016 in first-line treatment, neoadjuvant chemotherapy, immunotherapy, and other targeted therapies. Currently, JSKN016 has been undergoing Phase II clinical studies as a monotherapy and in combination therapy for lung cancer, BC, and a Phase III clinical study for TNBC is ongoing, offering a promising and more effective and safe treatment option for patients.