Study of APG-115 and APG-2575 for T-PLL and NHL

This study is testing two drugs, APG-115 and APG-2575, for people with T-Prolymphocytic Leukemia (T-PLL) and Non-Hodgkin Lymphoma (NHL) that has come back or not responded to previous treatments. Researchers want to see how safe these drugs are, how well they work, and how your body processes them. APG-115 works by interfering with a protein called MDM2, which can help activate a natural tumor-fighting process in your body called apoptosis (programmed cell death). You might receive APG-115 alone or in combination with APG-2575. The main goals are to find the highest safe dose for APG-115 by itself and when combined with APG-2575. To join, you must be at least 18 years old and have T-PLL or NHL that has relapsed, is refractory (not responding to treatment), or you can't take other standard therapies. The study is planned to include 78 participants, but its current recruitment status is unclear.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is a Phase IIa study, designed to evaluate the drugs in a group of patients.
What's involved
APG-115 is given every other day for two weeks, followed by one week off, in repeated 21-day cycles. APG-2575 is taken by mouth every day during each 21-day cycle.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for determining the maximum tolerated dose are measured at 21 days.

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NCT04496349

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Ascentage Pharma Group Inc.
~78 participants
Updated 2025-11-04 on ClinicalTrials.gov
What's tested:APG-115APG-2575

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose of APG-115
Measured over 21 days
+1 more outcome measured
T-Prolymphocytic Leukemia
Non-Hodgkins Lymphoma
1 sites across 1 states
Texas1
  • Yifan Zhai, MD, PhD · STUDY_CHAIR · Ascentage Pharma Group Inc.

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  • Maximum tolerated dose of APG-11521 days

    To evaluate the safety of APG-115 as a single agent

  • Maximum tolerated dose of APG-115+APG-257521 days

    To evaluate the maximum tolerated dose of APG-115 and APG-2575 in combination