Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory AML

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, pharmacokinetic of APG-2575 single agent and in combination with HHT/AZA in patients with relapsed/refractory AML.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascentage Pharma Group Inc.
• Collaborators: Suzhou Yasheng Pharmaceutical Co., Ltd; Suzhou Yasheng Pharmaceutical Co., Ltd.
• Treatments: Azacitidine

Criteria

Inclusion Criteria:

Subjects who meet each of the following inclusion criteria are eligible to participate in this study:

1. Age ≥18 years old.

2. In accordance with the World Health Organization (WHO) 2016 diagnostic criteria for primary AML, patients diagnosed as R/R AML (blasts in bone marrow >5%) after treatment, except for acute promyelocytic (APL) and t(9;22) AML.

3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -2.

4. Subjects can accept oral administration of APG-2575.

5. Life expectancy ≥ 3 months.

6. Adequate renal and liver function.

7. Males, female patients of childbearing potential (postmenopausal women who must have been menopausal for at least 12 months to be considered infertile) and their partners voluntarily take contraception which the investigator considers effective during treatment and at least three months after the last dose of study drug.

8. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).

9. Willingness and ability to comply with study procedures and follow-up examination.

Exclusion Criteria:

Patients who meet any of the following exclusion criteria are not to be enrolled in this study:

1. Patients diagnosed as acute promyelocytic leukemia (FAB classification AML-M3 or WHO diagnosis classification APL with PML-RARα) or BCR-ABL positive AML patients.

2. White blood cell (WBC) ≥100×109/L when screening.

3. The persistent toxicities caused by previous chemotherapy or radiotherapy has not been restored to lower than grade 2 by CTCAE 5.0 (except for alopecia).

4. Known leukemia infiltration of the central nervous system.

5. Symptomatic active fungal, bacterial and/or viral infections, including but not limited to active human immunodeficiency virus (HIV), viral hepatitis B or C (type B or C).

6. Prior history of allogeneic hematopoietic stem cell transplantation or adoptive cell immunotherapy or autologous hematopoietic stem cell transplantation within 12 months.

7. Requirement of therapeutic doses of anticoagulants and antiplatelet drugs, but allow the use of low doses of anticoagulants to maintain the opening of the central venous catheter.

8. Within 14 days before the first dose of study drug, received radiotherapy, surgery, immunotherapy, hormone therapy, targeted therapy, biological therapy or Chinese herbal therapy or any investigational treatment.

9. Within 14 days before the first dose of study drug, received hematopoietic cytokines (granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), or erythropoietin) .

10. Failure to recover adequately, at the discretion of the investigator, from prior surgical procedures, including patients who have had major surgery within 28 days before the first dose of study drug, and patients who have had minor surgery (excluding pathological biopsy) within 14 days before the beginning of study.

11. At the discretion of the investigator, gastrointestinal diseases that affect the absorption of APG-2575.

12. Unstable angina, myocardial infarction, coronary artery reconstruction, or severe gastrointestinal bleeding occurred during the 180 days before the start of study.

13. Uncontrolled complications include but not limited to: uncontrollable severe infections, symptomatic congestive heart failure, unstable angina, arrhythmia, or mental illness/social environment that may affect compliance.

14. The last treatment before signing the informed consent was a Bcl-2 inhibitor (subjects who had been treated with a Bcl-2 inhibitor but had not developed drug resistance could be enrolled in this study).

15. Any other condition or circumstance, at the discretion of the investigator, that patients would be unsuitable for participation in the study.