drugset / Trial / NCT06225843
Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis
NaSingle-groupOpen-labelTreatment
Summary
This Phase II study will recruit 17 colorectal cancer patients with liver-dominant metastases. All recruited patients will receive Sotevtamab at a dose of 800 mg once weekly for 6 cycles combined with FOLFOX once every 2 weeks for the first 4 cycles followed by liver metastases resection surgery with or without primary cancer resection. One cycle of treatment will consist of 14 days (2 weeks).
Timeline
- Start
- 2024-02-15
- Primary completion
- 2026-03
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sotevtamab | Monoclonal antibody | 800 mg | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |