The purpose of this trial is to assess the tolerability and safety of NB1011 in the treatment of patients with cancers that overexpress TS, such as ovarian, gastrointestinal, colorectal, bladder, breast, and lung cancers.

Inclusion Criteria:

• Advanced, recurrent, or metastatic solid tumors
• TS overexpression (> 4 by reverse transcription polymerase chain reaction [RT-PCR]) in archival and fresh samples
• Suitable for experimental monotherapy
• Measurable disease

Exclusion Criteria:

• Tumors that cannot be biopsied or with low level of TS expression
• Requirement for concomitant anticancer therapy
• Treatment with another investigational product within 30 days of study entry
• Pregnant or lactating women
• Active or uncontrolled serious bacterial, viral, fungal, or parasitic infection.
• HIV infection
• Clinically apparent meningeal or central nervous system (CNS) metastases or carcinomatous meningitis