A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas

Inclusion Criteria

• •To be considered eligible to participate in this study, all of the following requirements must be met:
• •1. Patients in Phase 1 must have metastatic or locally advanced solid tumors who have failed to respond to standard therapy
• •2. All patients must have confirmation of either ALK positive or TRK positive status.
• •3. Patients in Phase 1 will not be required to have measurable disease. All patients in Phase 2a will be required to have measurable disease by RECIST.
• •4. All patients enrolled in this study must have tumor tissue available.
• •5. Patient (male or female) must be ≥ 18 years of age (except where age of majority is 16 years in a particular country, such as the United Kingdom).
• •6. Patient must have performance status ≤2 on the ECOG Performance Scale.
• •7. Patient must have an estimated life expectancy of at least 3 months.
• •8. Patients must have adequate organ function.
• •9. For patients previously treated with myelosuppressive therapy, at least 3 weeks must have elapsed and toxicity must have recovered to grade 1 or baseline. Non-myelosuppressive therapy patients must have recovered from all treatment-related toxicities. Fourteen days must have elapsed since palliative radiation for bone metastasis.
• •10. Female patients of childbearing potential must have a negative serum pregnancy test and use adequate birth control for the duration of study participation and for 3 months after the last dose of study drug.
• •11. The patient or his or her legal representative must be able to read, understand, and provide signed informed consent.
• •12. Patient is able to understand the study procedures and agrees to participate in the study by giving written informed consent.