AOH1996 for the Treatment of Refractory Solid Tumors

Inclusion Criteria

• •Informed Consent and Willingness to Participate
• •1\. Documented informed consent by the participant
• •2\. Willingness to permit study team to obtain and use archival tissue, if already existing
• •Age Criteria, Performance Status and Life Expectancy
• •3\. Age: ≥ 18 years
• •4\. ECOG performance status ≤ 2
• •5\. Life expectancy of \> 3 months
• •Nature of Illness and Treatment History \_\_6. Patients with solid tumors failing standard therapies or patients refusing standard treatments (exception: Part B NSCLC combination (EGFR TKI + AOH1996) cohort: patients with stable disease or better on EGFR TKI for at least 2 months)
• •Contraception
• •\_\_7. Agreement by females and males of childbearing potential\* to use an adequate method of birth control (hormonal contraception is inadequate) or abstain from heterosexual activity for the course of the study through 30 days after the last dose of study medication. See Appendix B for guidelines.
• •\- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only).
• •Laboratory Criteria (to be performed within 14 days prior to Day 1)
• •8\. ANC ≥ 1,500/mm3
• •9\. Platelets ≥ 100,000/mm3 :
• •10\. Total serum bilirubin ≤ 1.5 x ULN
• •11\. AST =\< 1.5 x ULN or =\< 3 x ULN with liver metastases
• •12\. ALT =\< 1.5 x ULN or =\< 3 x ULN with liver metastases
• •13\. Creatinine clearance of ≥ 60 mL/min per 24 hour urine or the Cockcroft-Gault
• •14\. Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required