Actively Recruiting
APG-2575 Study of Safety, Tolerability ,PK/PD in Patients With Hematologic Malignancies
Led by Ascentage Pharma Group Inc. · Updated on 2024-08-19
90
Participants Needed
5
Research Sites
340 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
APG-2575 Study of Safety, Tolerability ,PK/PD in Patients With Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed B-cell hematologic malignancies including multiple myeloma, chronic lymphocytic leukemia, lymphoplasmacytic lymphoma, non-Hodgkin's lymphoma (mantle cell lymphoma, diffuse large B cell lymphoma), Waldenstrom macroglobulinemia, or acute myeloid leukemia
- Relapsed, refractory, intolerant to, or ineligible for therapies known to provide clinical benefit
- For AML patients: failed standard induction, not candidate for further chemotherapy or stem cell transplant, or primary refractory AML
- Life expectancy of at least 3 months
- ECOG Performance Status of 0-1 for dose escalation or 0-2 for dose expansion
- QTc interval ≤ 450 ms in males and ≤ 470 ms in females
- Adequate bone marrow function independent of growth factors
- Absolute neutrophil count ≥ 1.0 x 10^9/L
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 30 x 10^9/L without transfusion within 7 days before first dose
- Adequate kidney and liver function as indicated
You will not qualify if you...
- Prior history of allogeneic cell transplant
- Diagnosis of Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia
- Chemotherapy within 14 days (42 days for nitrosoureas or mitomycin C) prior to study entry
- Biologic therapy within 28 days, small molecule targeted therapy within 5 half-lives, or other anti-cancer therapy within 21 days of entry
- Radiation therapy within 14 days, thoracic radiation within 28 days before entry
- Gastrointestinal conditions affecting absorption of APG-2575
- Known active central nervous system involvement
- Unresolved toxicities from prior therapies greater than Grade 1 except alopecia or neuropathy
- Concurrent investigational agent treatment within 14 days (small molecules) or 28 days (biologics) before first dose
- Inadequate recovery from recent surgeries (major surgery within 28 days, minor surgery within 14 days)
- Unstable angina, recent myocardial infarction, or coronary revascularization within 180 days
- Active rheumatoid arthritis, inflammatory bowel disease, chronic infections, or other chronic inflammatory diseases
- Active infection requiring systemic antibiotics/antifungals, active hepatitis B or C, or on HIV antiretroviral therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
2
Duke Unviersity
Durham, North Carolina, United States, 27701
Completed
3
MDACC
Houston, Texas, United States, 77030
Actively Recruiting
4
St. Vincent Hospital
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
5
Epworth Healthcare
Richmond, Victoria, Australia, 3121
Actively Recruiting
Research Team
L
Laura Glass
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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