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

Recruiting Phase 2 Interventional Study
Metastatic Colorectal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
17 (estimated)
Sponsor
Alethia Biotherapeutics · Industry
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participants (male or non-pregnant female) must be ≥ 18 years of age on the day of signing the informed consent. 2. Participants with stage IV colon or rectal adenocarcinoma with resectable liver-dominant metastases and candidate to neoadjuvant FOLFOX followed by partial hepa…
Contacts

Julie Laurin, B. Pharm, Ph.D.

514-581-8125

julie.laurin@alethiabio.com

CONTACT