drugset / Trial / NCT06225843

Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis

NCT06225843

Phase 2 Recruiting 17 enrolled Alethia Biotherapeutics
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

EvaluationDrugModalityDoseRoute
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

Indications