Study on APG-115 Alone or with APG-2575 for Treating Relapsed or Refractory T-PLL and NHL
Sponsor: Ascentage Pharma Group Inc.
ClinicalTrials ID:NCT04496349
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
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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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope | 91010 | Duarte | California |
| Ohio State University | 43210 | Columbus | Ohio |
| MD Anderson | 77030 | Houston | Texas |
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