HER2-positive colorectal cancer is a biomarker-defined subset of colorectal adenocarcinoma with HER2 overexpression or amplification. This subtype is clinically important because anti-HER2 targeted therapies can be effective in selected metastatic settings. Molecular profiling is required to identify eligible patients.
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 |
|---|---|---|---|
| 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 |
| NCT06253871 |
A Phase 1/1b Study of IAM1363 in HER2 Cancers |
RECRUITING | PHASE1 |
| NCT05985707 |
KN026 Plus Chemotherapy ± KN-046 in HER2 Positive Colorectal Cancer and Biliary Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT05514717 |
A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2 |
RECRUITING | PHASE1 |
| NCT05091528 |
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers |
TERMINATED | PHASE1/PHASE2 |
| NCT04278144 |
A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors |
TERMINATED | PHASE1/PHASE2 |
