JSKN003 is an investigational anti-HER2 biparatopic/bispecific antibody-drug conjugate with a topoisomerase I payload, being developed for advanced solid tumors. It has shown promising safety and antitumor activity in studies in China and Australia, and U.S. FDA has cleared a Phase II study in platinum-resistant ovarian-related cancers. Multiple Phase III studies are ongoing in China.
Alphamab Oncology dosed the first patient in its Phase III trial of JSKN003, a biparatopic HER2-targeting antibody-drug conjugate, for HER2-positive advanced colorectal cancer on February 14, 2026.
Alphamab Oncology has dosed the first patient in a Phase III study of JSKN003, a biparatopic HER2-targeting ADC, for HER2-positive advanced colorectal cancer. The drug demonstrated a 68.8% response rate in earlier trials.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07545044 |
A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07384377 |
JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan |
NOT_YET_RECRUITING | PHASE3 |
| NCT06998771 |
JSKN003 Combined Treatment of HER2-positive Gastric Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT06846437 |
JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer |
RECRUITING | PHASE3 |
| NCT06751485 |
JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer |
NOT_YET_RECRUITING | PHASE3 |
| NCT06079983 |
JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects |
RECRUITING | PHASE3 |
| NCT05744427 |
Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
| NCT05582499 |
Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy |
RECRUITING | PHASE2 |
| NCT05494918 |
First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors |
COMPLETED | PHASE1 |
