A Phase I Open-Label, Ascending Dose Cohort Study of Gemcitabine Elaidate and Cisplatin in Patients With Advanced Solid Tumors Followed by an Expanded Cohort of Patients With Stage IIIb/IV NSCLC.

Inclusion Criteria:

- Understand and sign institutional review board/independent ethics committee-approved
informed consent form (ICF) prior to any study-specific evaluation

- Life expectancy of at least 3 months

- ECOG performance status of 0 to 1

- ≥ 18 years at the time ICF is signed

- Adequate hematological and biological function

- Histologically or cytologically confirmed solid tumor malignancy (Part 1 only)

- Histologically or cytologically confirmed stage IIIb/IV NSCLC (Part 2 only)

Exclusion Criteria:

- Symptomatic central nervous system metastases

- Concomitant treatment with prohibited medications, e.g. other chemotherapy,
radiation, hormonal treatment (excepting corticosteroids), or immunotherapy ≤ 14 days
prior to CO-1.01 treatment

- Treatment with a previous regimen of CO-1.01

- Participation in another therapeutic clinical study within 14 days of enrollment or
during this clinical study

- Surgical procedures ≤ 14 days prior to CO-1.01 administration

- History of allergy to gemcitabine, gemcitabine elaidate or eggs

- Known allergic/hypersensitivity reaction to cisplatin, other platinum agent, or
platinum containing compounds

- Peripheral neuropathy ≥ Grade 1

- Females who are pregnant or breastfeeding

- Refusal to use adequate contraception for fertile patients

- Presence of any serious or unstable concomitant systemic disorder incompatible with
the clinical study

- Any other reason the investigator considers the patient should not participate in the
study