Study on APG-115 Alone or Combined with Azacitidine for Patients with AML, CMML, or MDS

Sponsor: Ascentage Pharma Group Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04358393

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, APG-115, alone and in combination with another drug, Azacitidine, for patients with certain types of blood cancers that have returned or are not responding to treatment.

Patient Parameters

Program Overview

This study is divided into two parts. In the first part, researchers will test the safety of APG-115 when given by itself to patients with relapsed or refractory acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), or high-risk myelodysplastic syndrome (MDS). In the second part, they will test the combination of APG-115 with another drug called 5-azacitidine (5-AZA) to see if it is safe and effective.

Description

In Part 1 of the study, the dose of APG-115 will be gradually increased to find the safest and most effective dose. Patients will take APG-115 by mouth once a day for five days in a 28-day cycle. The starting dose is 100 mg, and it may be increased to 150 mg, 200 mg, and 250 mg in different groups of patients.

In Part 2, the study will test APG-115 in combination with 5-AZA. The dose of APG-115 will be adjusted similarly, while 5-AZA will be given as an injection under the skin for seven days in a 28-day cycle. The goal is to find the best dose combination that is safe and effective for patients.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with relapsed or refractory AML, CMML, or high-risk MDS, with no other standard treatments available.
  • Good liver and kidney function, as shown by specific blood tests.
  • Heart function of at least 45% as measured in the last three months.
  • Able to perform daily activities with some limitations (ECOG score of 0 to 2).
  • Women of childbearing age must have a negative pregnancy test before joining the study.
  • Must understand the study and sign a consent form.
  • Expected to live at least 12 more weeks.
  • White blood cell count below a certain level, with medication allowed to meet this requirement.

Exclusion Criteria

  • Pregnant women cannot participate.
  • Have uncontrolled illnesses, such as infections or heart problems, that could interfere with the study.
  • Have received leukemia treatment within 14 days before starting the study drug, except for certain medications allowed until 24 hours before starting the study.
  • Have a specific type of leukemia called acute promyelocytic leukemia.
  • Have active infections requiring treatment or certain viral infections like hepatitis B, C, or HIV.
  • Have had a stem cell transplant within the last 12 months or have ongoing complications from a transplant.
  • Allergic to any components of the study drugs.
  • Have active leukemia in the central nervous system.
  • Men and women of childbearing potential who do not use contraception.
  • Have previously received a specific type of cancer treatment called MDM2-p53 inhibitor.
  • Have other conditions that make participation unsuitable, as judged by the study doctor.
  • Have had other cancers within the last two years, except for certain skin cancers or other cancers treated with curative intent.
  • Have not fully recovered from previous cancer treatments.
  • Have significant heart rhythm problems as shown on an ECG.

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