A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer

Inclusion Criteria:

* 18 years or older.
* Histologically confirmed, unresectable, locally advanced or metastatic colorectal adenocarcinoma (stage III and IV), not amenable to curative surgery or radiotherapy.
* Intolerant of oxaliplatin and/or irinotecan, as demonstrated by unacceptable toxicity after a trial of these agents as first-line therapy, or in the opinion of the Investigator, be judged at high risk for unacceptable toxicity to oxaliplatin and/or irinotecan,
* Presence of at least 1 measurable lesion,
* Have a life expectancy of at least 4 months.
* Women of childbearing potential, have a negative serum pregnancy test at screening and Day 1 treatment and agree to practice abstinence or use an effective method of contraception.

Exclusion Criteria:

* Central nervous system metastasis.
* Bony metastasis as the sole metastasis.
* Received any prior first-line chemotherapy for colorectal cancer.
* Previously exposed to DAVANAT® or Avastin®.
* Known or clinically suspected infection with HIV.
* Participated within 30 days or will participate concurrently in another investigational drug or vaccine study.
* History of drug or alcohol dependence in the past 3 years.
* Other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that in the judgment of the Investigator could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.