A Phase IIa Study Evaluating the Pharmacokinetics, Safety and Efficacy of APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With Relapsed/Refractory T-Cell Prolymphocytic Leukemia (R/R T-PLL) or Non-Hodgkin's Lymphoma (NHL).
Summary
The goal of this study is to evaluate the pharmacokinetics (PK), safety, and efficacy of APG-115 as a single agent or in combination with APG-2575 in patients with T-PLL and NHL.
Detailed description
This is a phase IIa, open-label, multi-center, clinical trial of interfering the binding of MDM2 oncoprotein with the tumor suppressor P53 protein, leads to increased P53 and P21 protein expression and activates P53-mediated apoptosis. The hypothesis is that APG-115 monotherapy and in combination with APG-2575 will shows good safety and efficacy in patients with R/R T-PLL and NHL
Arms & interventions
- DrugAPG-115
QOD, 2 weeks on, 1 week off, in repeated 21-day cycles
- DrugAPG-2575
APG-2575 given orally each day in cycle, in repeated 21-day cycles
Outcome measures
Primary
Maximum tolerated dose of APG-115
To evaluate the safety of APG-115 as a single agent
Time frame: 21 days
Maximum tolerated dose of APG-115+APG-2575
To evaluate the maximum tolerated dose of APG-115 and APG-2575 in combination
Time frame: 21 days
Eligibility criteria
Study locations (1)
MD Anderson
Houston, Texas, 77030