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Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis - Trial NCT06225843

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.

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NCT06225843
Phase 2
Recruiting
biological
Trial Details
ClinicalTrials.gov โ€ข NCT06225843
View on ClinicalTrials.gov
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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

Study Focus

Sotevtamab

Interventional

biological

Sponsor & Location

Alethia Biotherapeutics

Montrรฉal, Canada

Timeline & Enrollment

Phase 2

Feb 15, 2024

Jun 01, 2025

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 colon
Malignant neoplasm: Colon, unspecified
Malignant neoplasm: Descending colon
Malignant neoplasm: Ascending colon
Malignant neoplasm: Overlapping lesion of colon

Data Source

ClinicalTrials.gov

NCT06225843

Non-Device Trial