Subjects with resectable adenocarcinoma of the colon and who, at the time of screening, are considered to fulfil the local criteria for adjuvant post-operative chemotherapy. Based on CT/MRI subjects should be judged to be: T1-4, N1-2, M0 or T4, N0, M0.
Conditions
Interventions
Product Name: Foxy-5
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: Foxy-5
CAS Number: 881188-51-8
Oth
Sponsors
WntResearch
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ability to understand and willingness to provide written informed consent before any trial-related activities. 2. Age = 18 years. 3. Male or female subjects with adenocarcinoma of the colon, judged by CT or MRI as either one of the following stages per TNM classification of colon cancer (8th edition, 2017): T1-4, N1-2, M0 or T4, N0, M0 and who are considered to fulfil the local criteria for adjuvant post-operative chemotherapy after scheduled surgery. 4. Scheduling of surgery according to local practice allows at least 9 pre-surgery administrations of Foxy-5 for the subject. (Please note: surgery should not be postponed for trial treatments). 5. Sexually active women of childbearing potential (WOCBP) and males with WOCBP partners who are randomized to the Foxy-5 Arm must use a highly effective method of contraception for the treatment duration and for 28 days after last Foxy-5. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 7. Clinical laboratory values at screening: a. Absolute neutrophil count =1.5 x 109/L b. Haemoglobin = 9 g/dL c. Platelets = 100 x 109/L d. Aspartate Transaminase (AST) and Alanine Transaminase (ALT) =1.5x Upper Limit of Normal (ULN) e. Serum bilirubin =1.5 x the ULN f. Creatinine clearance >60 mL/min (determined by Cockcroft-Gault Equation). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1. Assessed as not suitable or unable to tolerate adjuvant chemotherapy. 2. Evidence of distant metastatic (M1) disease at Screening (N1-2 is allowed). 3. Any surgery (except tumour biopsy) or therapy with immune suppressive agents or bone marrow stimulating factors within the last two weeks prior to randomization. 4. Any active infection requiring IV antibiotic treatment at the time of screening. 5. History of hematologic or primary solid tumour malignancy. Subjects in complete remission for at least 5 years or judged as cured by the Investigator may be included. Subjects with any prior non-invasive basal and squamous skin cell carcinoma, cervical carcinoma of Stage 1B or less, and non-invasive superficial bladder cancer may be included. 6. Pregnant or breastfeeding women. 7. Currently participating in another trial and receiving trial therapy or received investigational therapy within 4 weeks of the first dose of Foxy-5. 8. Any other condition or treatment that, in the opinion of the Investigator, might interfere with the trial or current drug or substance abuse. 9. Inability to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial. 10. Unlikely to comply with the protocol requirements, instructions and trial-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial 11. Legal incapacity or limited legal capacity. 12. Any condition, which results in an undue risk for the subject during the trial participation according to the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of Foxy-5 in subjects with colon cancer. To assess circulating tumour DNA (ctDNA) in plasma as a surrogate parameter for disease recurrences 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. ; Secondary Objective: To determine the preliminary efficacy of Foxy-5 in subjects with colon cancer by assessing: • Overall survival (OS) defined as the time of surgery until death due to any cause, assessed at two years after surgery. • Disease-free survival (DFS) defined as the time from surgery to tumour recurrence or death due to any cause, assessed at two years after surgery. • Recurrence-free interval (RFI) defined as the time from randomization to tumour recurrence. • Circulating tumour DNA (ctDNA) in plasma as a surrogate parameter for disease recurrences in subjects with Wnt-5a high colon cancer treated with Foxy-5 compared to subject with Wnt-5a high colon cancer who are in the Control Arm. ; Primary end point(s): 1) The incidence of adverse events (AEs) related to Foxy-5 administration and 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. 2) 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. ; Timepoint(s) of evaluation of this end point: 1) Ongoing during the trial and after administration of Foxy-5 is completed for all subjects 2) Ongoing during the trial until 2 years after resection of | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) OS at 2 years after resection of the colon cancer; 2) DFS at 2 years after resection of the colon cancer; 3) RFI 4) The level of ctDNA in plasma of subjects with Wnt-5a high colon cancer. ;Timepoint(s) of evaluation of this end point: If not otherwise specified in section E.5.2, ongoing during the trial and after follow-up period is completed for all subjects | — |
Countries
Netherlands, Spain
Contacts
Public ContactEsther Met
SMS-oncology
Outcome results
None listed