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