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Recruiting Phase 2

A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL

NCT04496349 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2021-07-12
Last updated
2025-11-04

Condition(s) studied

T-Prolymphocytic LeukemiaNon-Hodgkins Lymphoma

Investigational drug(s) / intervention(s)

APG-115 →APG-2575 →

APG-115: QOD, 2 weeks on, 1 week off, in repeated 21-day cycles

APG-2575: APG-2575 given orally each day in cycle, in repeated 21-day cycles

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years old 2. 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; 3. 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. 4. Absolute neutrophil count (ANC) ≥ 500/mm˄3; hemoglobin ≥ 60 g/L; platelet count ≥ 30,000/mm˄3 5. Patients with adequate organ function; 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; 7. 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: 1. Patient previously treated with a murine double minute 2 (MDM2) inhibitor. 2. Known active, uncontrolled central nervous system (CNS) malignancy 3. 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). 4. 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). 5. 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.

Primary outcome measure(s)

  • Maximum tolerated dose of APG-115 — 21 days
    To evaluate the safety of APG-115 as a single agent
  • Maximum tolerated dose of APG-115+APG-2575 — 21 days
    To evaluate the maximum tolerated dose of APG-115 and APG-2575 in combination

Trial sites (1)

FacilityCityRegionStatus
MD Anderson Houston Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04496349 on ClinicalTrials.gov ↗ ← All trials in the USA