Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects

Exclusion Criteria

• •1. Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• •2. Currently enrolled in another clinical study, except observational studies.
• •3. Has known active central nervous system metastases and/or lymphomatous meningitis.
• •4. Persisting toxicities related to prior anticancer treatment \> Grade 1.
• •5. Major surgery or significant traumatic injury within 6 weeks prior to Screening or planned major surgery during the study period.
• •6. Received live attenuated vaccine within 4 weeks of first dose.
• •7. Subjects with gastrointestinal disease that may significantly alter the absorption of the study drug.
• •8. Subjects with a plasma cell leukemia.
• •9. Subjects with prior history of malignancies, other than MM, lymphoma, or CLL/SLL, unless the subject has been free of the disease for ≥ 5 years.
• •10. Has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or pomalidomide.
• •11. Has known or suspected hypersensitivity to the excipients contained in the formulation of investigational product (IP).
• •12. Has been treated with an investigational agent (i.e., an agent not commercially available) within 28 days of initiating IP.
• •13. Prior treatment of any inhibitors of PD-1 or PD-L1 within 3 months prior to initiating IP.
• •14. Has any one of the following:
• •* Clinically significant abnormal ECG finding at Screening.
• •* Congestive heart failure.
• •* Myocardial infarction within 12 months prior to initiating IP.
• •* Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris.
• •* Peripheral neuropathy ≥ Grade 2.
• •* Subject has taken a strong inhibitor or inducer of CYP3A4/5 including grapefruit, St. John's Wort or related products within 2 weeks prior to dosing and during the course of study.
• •15. Has current or prior use of immunosuppressive medication within 14 days prior initiating IP.
• •16. Subject known to test positive for human immunodeficiency virus, active hepatitis B, or active hepatitis C.
• •17. Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis.
• •18. Subject is a female who is pregnant, nursing, or breastfeeding.