Actively Recruiting
Phase I Study of Safety, Tolerability, and Pharmacokinetics of Oral APG-2575 in Patients With Hematologic Malignancies
Led by Ascentage Pharma Group Inc. · Updated on 2024-08-19
90
Participants Needed
5
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating APG-2575, an oral drug, in patients with hematologic malignancies such as multiple myeloma, chronic lymphocytic leukemia, and other B-cell cancers. This early phase 1 trial aims to study the safety, tolerability, and how the drug behaves in the body. The study includes both a dose escalation stage and a dose expansion stage to find the best dose for patients who have relapsed or are refractory to other treatments. APG-2575 is given as an oral tablet once daily for 4-week cycles, starting at 20 mg with increasing doses in subsequent patient groups up to 800 mg. Dose escalation follows a specific plan with monitoring for side effects, and once the maximum tolerated dose (MTD) is determined, up to 20 patients will receive that dose in the expansion phase. The study is open-label, meaning all participants receive the drug, not a placebo. Participants will have regular assessments including blood tests to monitor drug levels, side effects, and anti-tumor effects, with safety and drug behavior measured over 28 days. The study also evaluates longer-term anti-tumor responses up to 2 years. Patients are monitored closely for any toxicities, and the total participation time varies depending on treatment response and tolerability. This study is sponsored by Ascentage Pharma Group Inc.
CONDITIONS
Brief 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
- AML patients eligible if failed standard induction, not candidates for further chemotherapy or stem cell transplant, or have primary refractory AML
- Life expectancy of at least 3 months
- ECOG Performance Status 0-1 for dose escalation; 0-2 for dose expansion
- QTc interval ≤450 ms in males and ≤470 ms in females
- Adequate bone marrow function independent of growth factor
- Absolute neutrophil count ≥1.0 x 10⁹/L
- Hemoglobin ≥8.0 g/dL
- Platelet count ≥30 x 10⁹/L independent of transfusion within 7 days of first dose
- Adequate renal and liver function
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 prior to study entry (42 days for nitrosoureas or mitomycin C)
- Biologic therapy within 28 days, small molecule targeted therapies within 5 half-lives, or other anti-cancer therapy within 21 days prior to study entry
- Radiation therapy within 14 days, thoracic radiation within 28 days of study entry
- Gastrointestinal conditions that could affect absorption of APG-2575
- Known active central nervous system involvement
- Unresolved toxicities from prior therapy above Grade 1 except alopecia or neuropathy
- Concurrent treatment with other investigational agents within specified timeframes
- Inadequate recovery from recent surgery
- Unstable angina, recent myocardial infarction, or coronary revascularization within 180 days
- Active rheumatoid arthritis, inflammatory bowel disease, chronic infections, or other chronic inflammatory conditions
- Active infection requiring systemic antibiotic/antifungal, active hepatitis B or C, or on antiretroviral therapy for HIV
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until dose escalation is complete and maximum tolerated dose is defined.
Participants receive oral APG-2575 once daily in 28-day cycles with dose escalation and expansion phases to determine the maximum tolerated dose.
Weekly visits for up to 4 weeks per cycle
Duration - Up to 2 years
Participants are monitored for anti-tumor effects and safety outcomes for up to 2 years after treatment.
Periodic visits depending on study schedule
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
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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