Dose Escalating Study of Foxy-5 in Breast-, Colon- or Prostate Cancer Patients

This is an interventional treatment trial for Metastatic Breast Cancer Read More

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
  • Must have an evaluable tumour appropriate for biopsy as determined by the Investigator.
  • 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
  • Patients in active anti-coagulating treatment must be evaluated according to local standards on the discretion of the Investigator..
  • 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(except for a single dose of palliative 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
  • Previous exposure to Foxy-5
  • History of severe allergic or hypersensitive reactions to excipients
  • Pregnant or breastfeeding women
  • Active and/or within the last 5 years histologically confirmed diagnosis of malignant melanoma, gastric cancer, pancreatic cancer, lung cancer or nasopharyngeal cancer
  • 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