90 Participants Needed

APG-2575 for Blood Cancers

Recruiting at 5 trial locations
BH
YZ
LG
Overseen ByLaura Glass
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

The provided research does not contain specific safety data for APG-2575 (Lisaftoclax) in blood cancer treatment. The studies mentioned focus on other drugs and their safety profiles in different cancer treatments.678910

Is the drug APG-2575 (Lisaftoclax) a promising treatment for blood cancers?

The information provided does not directly address APG-2575 (Lisaftoclax) or its effectiveness for blood cancers. Therefore, based on the given data, we cannot determine if APG-2575 is a promising treatment for blood cancers.1112131415

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

YZ

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

I am fully active or restricted in physically strenuous activity but can do light work.
I have been diagnosed with a specific type of blood cancer.
My condition hasn't improved with standard treatments, or I can't tolerate them.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

28 days per cycle

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.

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment, with anti-tumor effects evaluated every 8 weeks.

up to 2 years

Treatment Details

Interventions

  • APG-2575
Trial Overview 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.
Participant Groups
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

APG-2575 is already approved in China, United States for the following indications:

🇨🇳
Approved in China as Lisaftoclax for:
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
🇺🇸
Approved in United States as Lisaftoclax for:
  • 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

Trials
54
Recruited
5,700+

Findings from Research

Venetoclax treatment in patients with chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML) showed minimal impact on circulating T cells and natural killer (NK) cells, suggesting that these immune cells remain largely unaffected by the drug.
Significant depletion of B-cell populations was observed in patients with breast cancer receiving long-term venetoclax, indicating that while venetoclax can affect certain immune cells, it may be a suitable candidate for combination with immunotherapies to enhance antitumor responses.
Venetoclax treatment in patients with cancer has limited impact on circulating T and NK cells.Teh, CE., Peng, H., Luo, MX., et al.[2023]
Venetoclax is a highly effective small-molecule inhibitor targeting BCL2, showing a remarkable 79% response rate and 20% complete remission in patients with chronic lymphocytic leukemia (CLL) during a phase II trial.
The drug induces rapid apoptosis and significantly reduces tumor size within hours of administration, demonstrating both high efficacy and safety, and has been approved by the FDA and EMA for specific patient populations.
Venetoclax: Targeting BCL2 in Hematological Cancers.Scheffold, A., Jebaraj, BMC., Stilgenbauer, S.[2019]
Venetoclax, a proapoptotic drug, has shown significant clinical activity in pediatric patients with relapsed or refractory leukemias, with 5 out of 10 patients achieving hematologic complete remission (CR) in a study conducted across 11 Polish pediatric hemato-oncology centers.
The drug appears particularly effective in certain leukemia subtypes, such as poor-prognosis acute lymphoblastic leukemia (ALL) with TCF::HLF fusion, suggesting that BH3-mimetics like venetoclax could be beneficial in targeted treatments for children.
Venetoclax Use in Paediatric Haemato-Oncology Centres in Poland: A 2022 Survey.Bobeff, K., Pastorczak, A., Urbanska, Z., et al.[2023]

References

Venetoclax treatment in patients with cancer has limited impact on circulating T and NK cells. [2023]
Venetoclax: Targeting BCL2 in Hematological Cancers. [2019]
Venetoclax Use in Paediatric Haemato-Oncology Centres in Poland: A 2022 Survey. [2023]
225Ac-labeled CD33-targeting antibody reverses resistance to Bcl-2 inhibitor venetoclax in acute myeloid leukemia models. [2021]
Venetoclax-based combinations for acute myeloid leukemia: optimizing their use in Latin-America. [2022]
Lenalidomide can be safely combined with R-CHOP (R2CHOP) in the initial chemotherapy for aggressive B-cell lymphomas: phase I study. [2020]
A phase I study of an oral selective gamma secretase (GS) inhibitor RO4929097 in combination with neoadjuvant paclitaxel and carboplatin in triple negative breast cancer. [2021]
A phase 1 dose escalation and expansion study of Tarextumab (OMP-59R5) in patients with solid tumors. [2020]
Expanded safety experience with lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
A phase I, dose-escalation study of PF-06650808, an anti-Notch3 antibody-drug conjugate, in patients with breast cancer and other advanced solid tumors. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Expression of osteoprotegerin from a replicating adenovirus inhibits the progression of prostate cancer bone metastases in a murine model. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Treatment of prostate cancer with Ad5/3Delta24hCG allows non-invasive detection of the magnitude and persistence of virus replication in vivo. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Integrin targeted oncolytic adenoviruses Ad5-D24-RGD and Ad5-RGD-D24-GMCSF for treatment of patients with advanced chemotherapy refractory solid tumors. [2020]
RANK, RANKL and OPG Expression in Breast Cancer - Influence on Osseous Metastasis. [2021]
15.United Statespubmed.ncbi.nlm.nih.gov
Ad5NULL-A20: A Tropism-Modified, αvβ6 Integrin-Selective Oncolytic Adenovirus for Epithelial Ovarian Cancer Therapies. [2019]
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