NCT03883802

Foxy-5 as Neo-Adjuvant Therapy in Subjects With Wnt-5a Low Colon Cancer

A Randomized, Multicentre, Open-Label Controlled Phase II Trial of Foxy-5 as Neo-Adjuvant Therapy in Subjects With Wnt-5a Low Colon Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: WntResearch AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II study investigating the safety, tolerability and effect on disease reccurence of Foxy-5 as neo-adjuvant therapy in resected colon cancer patients treated with FOLFOX chemotherapy regimen. It is a two-arm study and patients will be randomised to receive either standard therapy (surgery + FOLFOX 6 months regimen) or standard therapy + neo-adjuvant administration of Foxy-5 prior to- and following surgery (maximum of 39 administrations) until initiation of FOLFOX therapy.

Detailed description

Foxy-5 is a synthetic hexapeptide with a formylated N-terminus, derived from the protein sequence of the Wnt-5a protein. Low/no expression levels of Wnt-5 protein in primary tumour cells have been correlated to high risk of recurrent metastatic disease and shortened survival in several different types of cancer patients, including colon cancer. Current standard therapy involves surgical removal of the tumour followed by 6 months treatment with chemotherapy (FOLFOX). Foxy-5 is expected to decrease migration of cancer cells, in subjects with low/absent levels of Wnt-5a protein in their primary tumour and hence result in lower recurrence and a better overall survival. The trial intends to establish the safety and tolerability of Foxy-5 and to evaluate early signs of anti-metastatic activity in subjects with resectable colon cancer.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DRUG	Foxy-5	Lyophilized powder for solution for intravenous infusion
DRUG	FOLFOX regimen	6 months treatment regimen
PROCEDURE	Tumour resection (colon cancer surgery)	Surgical removal of patients colon cancer

Timeline

• Start date: 2019-04-12
• Primary completion: 2024-12-14
• Completion: 2024-12-14
• First posted: 2019-03-21
• Last updated: 2022-12-09

Locations

1 site across 1 country: Spain