Regorafenib is marketed as STIVARGA, an oral multikinase inhibitor used in advanced colorectal cancer, gastrointestinal stromal tumor, and hepatocellular carcinoma after prior therapies. Labeling describes broad kinase inhibition across oncogenesis and angiogenesis pathways. U.S. prescribing information lists initial FDA approval in 2012.
Colorectal cancer rates are rising 3% annually in adults under 50, prompting expanded screening efforts and new treatment approaches. Recent research shows promise in combination immunotherapy and vaccine strategies for advanced disease.
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 |
|---|---|---|---|
| NCT07750041 |
A Phase Ib/II Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07730489 |
A Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, Fluorouracil and Irinotecan |
NOT_YET_RECRUITING | PHASE3 |
| NCT07567222 |
Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors |
RECRUITING | PHASE1 |
| NCT07537985 |
Efficacy and Safety Comparison Between PD-1 Inhibitor Combined With Lenvatinib or With Regorafenib For UHCC After Failure of First-line Treatment |
COMPLETED | NA |
| NCT07495579 |
Lenvatinib or Regorafenib for Advanced Hepatocellular Carcinoma After Immunotherapy (REVIVE) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07392866 |
A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07379047 |
Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) |
RECRUITING | PHASE2/PHASE3 |
| NCT07300488 |
Efficacy and Safety of Pracytarabine Versus Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma |
ACTIVE_NOT_RECRUITING | PHASE2/PHASE3 |
| NCT07223567 |
A Trial of Regorafenib Plus Lorigerlimab in Patients With Locally Recurrent or Regrowing pMMR/MSS Localized Rectal Cancer |
WITHDRAWN | PHASE2 |
| NCT07137390 |
A Trial of Regorafenib Plus Lorigerlimab as Neoadjuvant Therapy for Patients With pMMR/MSS, Resectable, Lung-limited Metastatic Colorectal Cancer |
WITHDRAWN | PHASE1/PHASE2 |
