ARQ 501 in Subjects With Cancer

A Phase I Clinical, Pharmacokinetic Study of ARQ 501 in Subjects With Advanced Solid Tumors

ARQ 501, an investigational anticancer drug, is intended to selectively kill cancer cells and spare normal cells by restoring and activating cellular checkpoints known to be defective in cancer using the Company's unique biology platform, Activated Checkpoint Therapy™ (ACT).

ARQ 501 has the potential for improved activity and reduced toxicity over other molecular approaches and traditional cancer chemotherapy.

Inclusion Criteria

• Histologically or cytologically confirmed solid tumor that is metastatic, unresectable or recurrent and for which standard curative or palliative measures do not exist or are no longer effective.
• ECOG performance status greater than or equal to 1
• Life expectancy greater than three months
• Acceptable pretreatment clinical laboratory results

Exclusion Criteria

• Subjects who have had chemotherapy or radiotherapy within 4 weeks
• Subjects receiving any other investigational agents
• Subjects with known untreated brain metastases
• Subjects receiving hepatic enzyme-inducing antiseizure drugs ("EIASD")
• Subjects with uncontrolled intercurrent illnesses
• Pregnant women