Study on APG-115 Alone or with APG-2575 for Treating Relapsed or Refractory T-PLL and NHL

Sponsor: Ascentage Pharma Group Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04496349

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, APG-115, used alone or with another drug, APG-2575, in patients with T-PLL and NHL who have not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to see how the drug APG-115, either by itself or combined with APG-2575, works in patients with T-PLL and NHL. Researchers want to understand how the drug moves through the body, its safety, and how well it works in treating these conditions.

Description

This study is a Phase IIa trial, meaning it is in the early stages of testing. It is open-label, so both doctors and patients know what treatment is being given. The trial is being conducted at multiple centers. The study focuses on how APG-115 affects proteins in the body that are involved in cancer cell death. The drug works by interfering with a protein called MDM2, which normally stops another protein, P53, from killing cancer cells. By blocking MDM2, APG-115 increases the levels of P53, leading to cancer cell death. The study is testing if APG-115 alone or with APG-2575 is safe and effective for patients with relapsed or refractory T-PLL and NHL.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have relapsed or refractory T-PLL with active disease and have tried at least one previous treatment.
  • Have a confirmed diagnosis of NHL and be relapsed, refractory, intolerant, or ineligible for other beneficial therapies.
  • No chemotherapy or antibody therapy for 7 days before starting the study drugs, except for certain medications allowed until 24 hours before starting.
  • Have a neutrophil count of at least 500/mm³, hemoglobin of at least 60 g/L, and platelet count of at least 30,000/mm³.
  • Have adequate organ function.
  • Have an ECOG performance status of 2 or less, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Be able to understand the study requirements and sign an informed consent form.

Exclusion Criteria

  • Have been treated with an MDM2 inhibitor before.
  • Have an active, uncontrolled cancer in the central nervous system.
  • Require treatment for graft versus host disease or need ongoing systemic immunosuppressive medications.
  • Have any condition that could compromise safety or interfere with the study, as judged by the study doctors.
  • Have used certain medications that affect liver enzymes within a specific time before starting the study drugs.

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