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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Lyophilized powder for solution for intravenous infusion
6 months treatment regimen
Surgical removal of patients colon cancer
Instituto de Investigación Sanitaria INCLIVA
Valencia, Spain
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The incidence of adverse events (AEs) related to Foxy-5 administration of Grade 3 and higher according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) and the Clavien-Dindo classification of surgical complications. cancer.
Time frame: From date of randomization until 28 days after the last dose of Foxy-5, assessed up to 120 days
ctDNA as surrogate marker for disease free period
The level of ctDNA in plasma of subjects with Wnt-5a low colon cancer as a surrogate parameter for disease recurrence in subjects with Wnt-5a low colon cancer treated with Foxy-5 compared to subjects with Wnt-5a low colon cancer who are in the Control Arm.
Time frame: 2 years after resection of colon cancer
Overall survival
OS at 2 years after resection of the colon cancer
Time frame: 2 years after resection of tumour
Disease-Free Survival
DFS at 2 years after resection of the colon cancer
Time frame: 2 years after resection of tumour
Recurrence-Free Interval
Recurrence-free interval (RFI) defined as the time from randomization to tumour recurrence.
Time frame: study start to 2 years after resection of tumour
ctDNA in Wnt-5a high patients
The level of ctDNA in plasma of subjects with Wnt-5a high colon cancer.
Time frame: 2 years after resection of tumour
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