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

Inclusion Criteria

• ≥ 18 years of age
• Willing and able to provide written consent.
• Willing and able to adhere to the study visit schedule and other protocol requirements.
• Hematocytological or pathological diagnosis of MM, MCL, DLBCL, ATL, indolent lymphoma, such as FL and CLL/SLL, etc.
• Subjects who have relapsed from or are refractory to MM, MCL, DLBCL, ATL, indolent lymphoma, such as FL and CLL/SLL.
• Have measurable or assessable disease.
• Meet the laboratory requirements:
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Males and females of childbearing potential must agree to use at least two methods of contraception and continue until 3 months after the completion of study treatment.

Exclusion Criteria

• Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Currently enrolled in another clinical study, except observational studies.
• Has known active central nervous system metastases and/or lymphomatous meningitis.
• Persisting toxicities related to prior anticancer treatment > Grade 1.
• Major surgery or significant traumatic injury within 6 weeks prior to Screening or planned major surgery during the study period.
• Received live attenuated vaccine within 4 weeks of first dose.
• Subjects with gastrointestinal disease that may significantly alter the absorption of the study drug.
• Subjects with a plasma cell leukemia.
• 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.
• Has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or pomalidomide.
• Has known or suspected hypersensitivity to the excipients contained in the formulation of investigational product (IP).
• Has been treated with an investigational agent (i.e., an agent not commercially available) within 28 days of initiating IP.
• Prior treatment of any inhibitors of PD-1 or PD-L1 within 3 months prior to initiating IP.
• 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.
• Has current or prior use of immunosuppressive medication within 14 days prior initiating IP.
• Subject known to test positive for human immunodeficiency virus, active hepatitis B, or active hepatitis C.
• Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis.
• Subject is a female who is pregnant, nursing, or breastfeeding.