A Dose Escalation Trial of PR610 Treating Patients With Solid Tumors

Following informed consent, subjects undergo baseline evaluation and disease assessment. PR610 is administered intravenously weekly. In the absence of progressive disease or unacceptable toxicity, subjects may continue to receive PR610. Intra-subject dose escalation (to no higher than the highest safe level) is allowed in subjects who are not experiencing dose limiting toxicity. Disease assessment will be repeated at week 6 and then every 8 weeks thereafter. Pharmacokinetic (PK) assessment (PR610 and PR610E) will be performed for all subjects. After determination of the MTD and the determination of the phase II dose, additional subjects with NSCLC that is genetically resistant to reversible EGFR inhibitors will be accrued into an expansion cohort.