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APG-2575 for Blood Cancers
Phase < 1
Recruiting
Research Sponsored by Ascentage Pharma Group Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1 in dose escalation ; 0-2 in dose expansion.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer drug, APG-2575, to see if it is safe and effective.
Who is the study for?
This trial is for adults over 18 with certain blood cancers like multiple myeloma, chronic lymphocytic leukemia, and non-Hodgkin's lymphoma who haven't responded to or can't have standard treatments. They should expect to live at least 3 more months, be relatively active (able to care for themselves), and have a minimum level of white blood cells, hemoglobin, and platelets.
What is being tested?
The study is testing APG-2575's safety and how well it works in two stages: first finding the right dose and then seeing its effects on a larger group. It's an open-label trial which means everyone knows they're getting APG-2575; there’s no placebo.
What are the potential side effects?
Specific side effects of APG-2575 aren’t listed here but generally could include symptoms like nausea, fatigue, allergic reactions or other drug-specific adverse events that will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have been diagnosed with a specific type of blood cancer.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose (MTD)
Secondary study objectives
Anti-tumor effects of APG-2575
Area under the plasma concentration versus time curve (AUC)
Maximum plasma concentration (Cmax)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: single-agent, open-label, Phase I study of APG-2575Experimental Treatment1 Intervention
The study consists of the dose escalation stage and the dose expansion stage
Find a Location
Who is running the clinical trial?
Ascentage Pharma Group Inc.Lead Sponsor
52 Previous Clinical Trials
5,577 Total Patients Enrolled
Yifan Zhai, MD, PhDStudy ChairAscentage Pharma Group Inc.
18 Previous Clinical Trials
1,271 Total Patients Enrolled