A Phase I/II Study With BM7PE Immunotoxin in Colorectal Cancer Patients

Inclusion Criteria: * Histologically verified adenocarcinoma of colon or rectum * Ambulatory with an ECOG performance status 0-1 * At least 18 years of age * Progressive disease on or last line of standard chemotherapy or intolerance to further chemotherapy * Laboratory values as the following: ANC, Platelets, Hb, Creatinine, Bilirubin, ASAT, ALAT, Albumin levels, INR * Signed informed consent and expected cooperation of the patients for the treatment, and follow-up must be obtained and documented according to ICH GCP, and national/local regulations Exclusion Criteria: * History of prior metastatic disease the last 3 years * History of CNS or bone metastases * Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia * Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment * Alcohol or drug abuse * Any reason why, in the opinion of the investigator, the patient should not participate * Has a known history of Human Immunodeficiency Virus (HIV) * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected) * Is pregnant or breastfeeding, or expecting to conceive or father children within the project duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.