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NCT06225843

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

A Proof-of-Concept Phase II Trial to Evaluate the EMT Inhibitor Sotevtamab Combined With FOLFOX Administered as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis
Alethia Biotherapeutics·Phase 2·ClinicalTrials.gov·biologicalRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Metastatic Colorectal Cancer
Drug/Device/Intervention
Sotevtamab
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Alethia Biotherapeutics
Location
Montréal, Canada
Timeline & enrollment
Phase
Phase 2
Start date
Feb 15, 2024
End date
Jun 01, 2025
Enrollment
17 participants
Primary outcome

Rubbia-Brandt score at surgery,Treatment-Emergent Adverse Events

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).

ICD-10 classifications
Malignant neoplasm of colonMalignant neoplasm: Colon, unspecifiedMalignant neoplasm: Descending colonMalignant neoplasm: Ascending colonMalignant neoplasm: Overlapping lesion of colon
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06225843
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06225843 through Pure Global AI's free database. This Phase 2 trial is sponsored by Alethia Biotherapeutics and is currently Recruiting. The study focuses on Metastatic Colorectal Cancer. Target enrollment is 17 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.