APG-2575 for Blood Cancers
Trial Summary
Do I need to stop my current medications to join the trial?
The protocol does not specify if you need to stop your current medications. However, you cannot have received chemotherapy, biologic, small molecule targeted therapies, or other anti-cancer therapy within a certain period before the study. It's best to discuss your current medications with the study team.
What data supports the idea that APG-2575 for Blood Cancers (also known as: APG-2575, Lisaftoclax) is an effective treatment?
The available research does not provide specific data on APG-2575 for blood cancers. However, it discusses venetoclax, a similar drug, which shows effectiveness in treating blood cancers like chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). Venetoclax has been shown to rapidly reduce tumor size and achieve high response rates, with 79% of patients responding to treatment and 20% achieving complete remission. This suggests that drugs targeting similar pathways, like APG-2575, could potentially be effective as well.12345
What safety data is available for APG-2575 (Lisaftoclax) in blood cancer treatment?
Is the drug APG-2575 (Lisaftoclax) a promising treatment for blood cancers?
What is the purpose of this trial?
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.
Research Team
Yifan Zhai, MD, PhD
Principal Investigator
Ascentage Pharma Group Inc.
Eligibility Criteria
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.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
APG-2575 is administered orally, once daily for 4 weeks per cycle. Dose escalation follows a single patient cohort model, increasing from 20mg to 800mg, with conversion to a 3+3 design if certain toxicities are observed.
Dose Expansion
After determining the Maximum Tolerated Dose (MTD), up to 20 patients will be treated at that dose level to further assess safety and efficacy.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with anti-tumor effects evaluated every 8 weeks.
Treatment Details
Interventions
- APG-2575
APG-2575 is already approved in China, United States for the following indications:
- Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
- None approved yet; under investigation for CLL/SLL, Waldenström macroglobulinemia, multiple myeloma, and acute myeloid leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ascentage Pharma Group Inc.
Lead Sponsor