This is a multi-center, single-agent, open-label, Phase I study of APG-2575. The study consists of the dose escalation stage and the dose expansion stage.
Age ≥18 years old.
Histologically confirmed diagnosis of either one of the B-cell hematologic malignancies including multiple myeloma, chronic lymphocytic leukemia, lymphoplasmacytic lymphoma, and non-Hodgkin's lymphoma such as mantle cell lymphoma, diffuse large B cell lymphoma, Waldenstrom macroglobulinemia (WM) and acute myeloid leukemia
Patient must have relapsed or refractory to, intolerant to, or are considered ineligible for therapies known to provide clinical benefit. In addition,
Life expectancy ≥ 3 months.
Prior history of allogeneic cell transplant.
Subjects have been diagnosed with Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia.
Received chemotherapy within 14 days (42 days for nitrosoureas or mitomycin C) prior to entering the study.
Received biologic (< 28 days), small molecule targeted therapies (< 5 half-life) or other anti-cancer therapy within 21 days of study entry.
Single group
APG-2575
DrugAPG-2575 will be administered as an oral tablet
Maximum Tolerated Dose (MTD)
Patients with APG-2575 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.0
Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax) will be assessed in the patients treated with APG-2575
Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC) of APG-2575 will be assessed in the patients treated with APG-2575
Anti-tumor effects of APG-2575
Response will be evaluated every 2 cycles (8 weeks), by the investigator based on disease specific criteria.
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