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A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL
Trial Status: active
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.
Inclusion Criteria
Age ≥ 18 years old
Patients with relapsed/refractory T-PLL who have active disease and have received at least one prior therapy; Patients with histologically confirmed diagnosis of NHL, NHL Patients must be either relapsed, refractory, intolerant, or are considered ineligible for therapies known to provide clinical benefit;
Patients must not have had chemotherapy or antibody therapy for 7 days prior to starting APG-115 and/or APG-2575. However, patients with rapidly proliferative disease may receive hydroxyurea or decadron until 24 hours prior to starting therapy on this protocol.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his/her legally authorized representative is required prior to their enrollment on the protocol.
Exclusion Criteria
Patient previously treated with a murine double minute 2 (MDM2) inhibitor.
Known active, uncontrolled central nervous system (CNS) malignancy
Patients require graft versus host therapy, or require continued treatment with systemic immunosuppressive agents (calcineurin inhibitors within 4 weeks prior to the first dose of study drug).
Patients who have any conditions or illness that, according to the opinions of the Investigators or the medical monitor, would compromise patient safety or interfere with the evaluation of safety and efficacy to the study drug(s).
Patients who have used strong CYP2C8 inhibitors, or moderate or strong CYP3A4 inhibitors or inducers within washout period of 14 days or 7 half-lives before the first administration of study drugs, whichever is longer.
Additional locations may be listed on ClinicalTrials.gov for NCT04496349.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
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