RECRUITING

APG-2575 Study of Safety, Tolerability ,PK/PD in Patients With Hematologic Malignancies

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multi-center, single-agent, open-label, Phase I study of APG-2575. The study consists of the dose escalation stage and the dose expansion stage.

Official Title

A Phase I Study of Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Property of Orally Administered APG-2575 in Patients With Hematologic Malignancies

Quick Facts

Study Start:2018-08-07

Study Completion:2025-02-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03537482

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥18 years old. 2. Histologically confirmed diagnosis of either one of the B-cell hematologic malignancies including multiple myeloma, chronic lymphocytic leukemia, lymphoplasmacytic lymphoma, and non-Hodgkin's lymphoma such as mantle cell lymphoma, diffuse large B cell lymphoma, Waldenstrom macroglobulinemia (WM) and acute myeloid leukemia 3. Patient must have relapsed or refractory to, intolerant to, or are considered ineligible for therapies known to provide clinical benefit. In addition, 4. Life expectancy ≥ 3 months. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1 in dose escalation ; 0-2 in dose expansion. 6. QTc interval ≤450ms in males, and ≤470ms in females. 7. Adequate bone marrow function independent of growth factor: 8. Absolute neutrophil count (ANC) ≥1.0 X 109/L. 9. Hemoglobin ≥ 8.0 g/dL. 10. Platelets count ≥ 30 X 109/L (entry platelet count must be independent of transfusion within 7 days of first dose). 11. Adequate renal and liver function as indicated by:	1. Prior history of allogeneic cell transplant. 2. Subjects have been diagnosed with Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia. 3. Received chemotherapy within 14 days (42 days for nitrosoureas or mitomycin C) prior to entering the study. 4. Received biologic (\< 28 days), small molecule targeted therapies (\< 5 half-life) or other anti-cancer therapy within 21 days of study entry. 5. Radiation within 14 days of study entry, thoracic radiation within 28 days of study entry. 6. Has gastrointestinal conditions that could affect the absorption of APG-2575 in the opinion of the Investigator. 7. Has known active central nervous system (CNS) involvement. 8. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to ≤ Grade 1 except alopecia or neuropathy. 9. Concurrent treatment with an investigational agent, 14 days for small molecular agents and/or 28 days for biologics treatment prior to the first dose of therapy. 10. Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients with active wound healing, patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry. 11. Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry. 12. Active rheumatoid arthritis (RA), active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation. 13. Active infection requiring systemic antibiotic/ antifungal medication, known clinically active hepatitis B or C infection, or on antiretroviral therapy for HIV disease.

Inclusion Criteria

Exclusion Criteria

1. Age ≥18 years old.
2. Histologically confirmed diagnosis of either one of the B-cell hematologic malignancies including multiple myeloma, chronic lymphocytic leukemia, lymphoplasmacytic lymphoma, and non-Hodgkin's lymphoma such as mantle cell lymphoma, diffuse large B cell lymphoma, Waldenstrom macroglobulinemia (WM) and acute myeloid leukemia
3. Patient must have relapsed or refractory to, intolerant to, or are considered ineligible for therapies known to provide clinical benefit. In addition,
4. Life expectancy ≥ 3 months.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1 in dose escalation ; 0-2 in dose expansion.
6. QTc interval ≤450ms in males, and ≤470ms in females.
7. Adequate bone marrow function independent of growth factor:
8. Absolute neutrophil count (ANC) ≥1.0 X 109/L.
9. Hemoglobin ≥ 8.0 g/dL.
10. Platelets count ≥ 30 X 109/L (entry platelet count must be independent of transfusion within 7 days of first dose).
11. Adequate renal and liver function as indicated by:

1. Prior history of allogeneic cell transplant.
2. Subjects have been diagnosed with Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia.
3. Received chemotherapy within 14 days (42 days for nitrosoureas or mitomycin C) prior to entering the study.
4. Received biologic (\< 28 days), small molecule targeted therapies (\< 5 half-life) or other anti-cancer therapy within 21 days of study entry.
5. Radiation within 14 days of study entry, thoracic radiation within 28 days of study entry.
6. Has gastrointestinal conditions that could affect the absorption of APG-2575 in the opinion of the Investigator.
7. Has known active central nervous system (CNS) involvement.
8. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to ≤ Grade 1 except alopecia or neuropathy.
9. Concurrent treatment with an investigational agent, 14 days for small molecular agents and/or 28 days for biologics treatment prior to the first dose of therapy.
10. Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients with active wound healing, patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.
11. Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry.
12. Active rheumatoid arthritis (RA), active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation.
13. Active infection requiring systemic antibiotic/ antifungal medication, known clinically active hepatitis B or C infection, or on antiretroviral therapy for HIV disease.

Contacts and Locations

Study Contact

Laura Glass

CONTACT

301-520-5964

Laura.Glass@ascentage.com

Principal Investigator

Yifan Zhai, MD, PhD

STUDY_CHAIR

Ascentage Pharma Group Inc.

Study Locations (Sites)

Mayo Clinic

Jacksonville, Florida, 32224

United States

Duke Unviersity

Durham, North Carolina, 27701

United States

MDACC

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Ascentage Pharma Group Inc.

Yifan Zhai, MD, PhD, STUDY_CHAIR, Ascentage Pharma Group Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-07

Study Completion Date2025-02-15

Study Record Updates

Study Start Date2018-08-07

Study Completion Date2025-02-15

Terms related to this study

Additional Relevant MeSH Terms

Hematologic Malignancies