Phase I Study to Evaluate Safety, Tolerability, Anti-Tumour Activity and PK Profiles of Foxy-5 in Metastatic Breast, Colon or Prostate Cancer

Inclusion criteria

• Males and females of at least 18 years of age
• Histologically/cytologically documented diagnosis of metastatic breast, colon or prostate cancer, refractory to standard therapy or for which no curative therapy exists
• Loss of or reduced Wnt-5a protein expression in primary or metastatic tumour cells, characterised by IHC analysis
• Eastern Cooperative Oncology Group (ECOG) performance status of <= 1
• Life expectancy of at least 3 months
• Unresectable disease, i.e. the metastases cannot be surgically removed with a curative intent
• >= 4 weeks must have elapsed since the patient has received any other IMP
• >=4 weeks must have elapsed since the patient has received any anti cancer treatment; including radiotherapy (except for single dose of palliative radiotherapy), cytotoxic chemotherapy, biologic agents or targeted therapy
• >= 2 weeks must have elapsed since any prior surgery or therapy with bone marrow stimulating factors
• Adequate haematological functions as defined by:
• Absolute neutrophil count >= 1.5 10E9/L
• Platelets >= 100 10E9/L
• Hemoglobin >= 5.6 mmol/L
• Adequate hepatic function as defined by:
• Total bilirubin <= 1.5 x the upper limit of normal (ULN)
• Aspartate aminotransferase (AST) <= 2.5 x ULN*
• Alanine aminotransferase (ALT) <= 2.5 x ULN*

• For patients with liver metastasis adequate hepatic function is defined by AST <= 5 x ULN and ALT <= 5 ULN.
• Adequate renal function as defined by Serum creatinine <= 1,5 x ULN
• Provision of written informed consent
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
• Sexually active males and females of child-producing potential, must use adequate contraception (intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release) or diaphragm always with spermicidal jelly and a male condom) for the study duration and at least six months afterwards

Exclusion criteria

• Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease)
• Any active infection requiring antibiotic treatment
• Known infection with human immunodeficiency virus (HIV) or hepatitis virus
• Active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or symptomatic arrhythmias currently requiring medication
• Known or suspected active central nervous system (CNS) metastasis. (Patients stable 8 weeks after completion of treatment for CNS metastasis are eligible)
• Impending or symptomatic spinal cord compression or carcinomatous meningitis
• Requiring immediate palliative surgery and/or radiotherapy
• Pre-existing neuropathy, i.e., Grade >2 neuromotor or neurosensory toxicity
• Participation in other clinical studies within 4 weeks of first dose of study treatment
• History of severe allergic or hypersensitive reactions to excipients
• Pregnant or breastfeeding women
• Chronic immunosuppressant use (e.g. systemic steroids for treatment of autoimmune disease)
• History of second malignancy, including histologically confirmed diagnosis of malignant melanoma except for carcinoma in situ or basal cell carcinoma
• Severe or uncontrolled chronic or uncontrolled systemic disease (e. g. severe respiratory or cardiovascular disease)
• Other medications or conditions that in the Investigator's opinion would contraindicate study participation of safety reasons or interfere with the interpretation of study results