A Phase I Open-Label Study to Evaluate the Safety and Tolerability of Escalating Doses of GM-CT-01 in the Presence and Absence of 5-Fluorouracil (5-FU) in Subjects With Advanced Solid Tumors

Inclusion Criteria:

- The subject is able to give informed consent to participate in this trial (including
all procedures and follow-up visits).

- The subject is male or female at least 18 years of age.

- The subject has a documented histologic or cytologic recurrent or metastatic solid
tumor that is not amenable to curative surgery, radiotherapy, or conventional
chemotherapy of proven value.

- Subjects must have completed previous therapy (chemotherapeutic agents or other
therapies including radiation) at least 4 weeks prior to study entry.

- Following major surgery (e.g. laparotomy), > 4 weeks must have elapsed and subjects
must have recovered from effects.

- Following minor surgery (does not include insertion of vascular access device), > 2
weeks must have elapsed.

- ECOG performance status of 0-2.

- The subject has a life expectancy of at least 12 weeks.

- Female subjects must be post-menopausal, surgically sterile, or using effective
contraception.

Laboratory values prior to administration of study drug:

- If female and not post-menopausal, the subject has a negative pregnancy test.

- Liver function studies: AST and ALT < 2.5 times the upper limit of normal (ULN);
total bilirubin < 1.5

- Hematopoietic parameters: WBC > 3000 per mm3; Granulocyte count > 1,500 per mm3;
Platelet count > 100,000 per mm3

- Renal: Creatinine < or = ULN

- Pulmonary: Dlco > or = 60% of predicted

Exclusion Criteria:

- If female, the subject is pregnant or breast feeding.

- Central nervous system (CNS) metastases or primary CNS tumors.

- The subject has a known hypersensitivity to GM-CT-01 or any of its components.

- The subject has congestive heart failure or any other medical condition that could be
adversely affected by intravenous infusion of up to approximately 200 mL of fluid
over 60 minutes.

- The subject is currently abusing alcohol and/or illicit drugs.

- The subject has other significant medical, psychiatric, or social conditions which,
in the investigators' opinion, may compromise the subject's safety in participating
in this study.

- In the investigators' judgment, the subject would be unreliable in adhering to the
study visit schedule or other study requirements.

- The subject is currently enrolled in a clinical trial or has participated in a
clinical trial within the 30 days prior to entry into this study.