Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as APG-2575, APG-2575(Lisaftoclax )
APG2575 · 1 trial · 1 indication
DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 6 weeks (2 cycles) of study treatment. These will be assessed via CTCAE version 5.0
MTD will be determined based on DLTs observed during the first 6 weeks (2 cycles) of study treatment
| Arm | Type | Description |
|---|---|---|
| APG2575 400 mg | EXPERIMENTAL | APG2575 400mg ramp up arm |
| APG2575 600 mg | EXPERIMENTAL | APG2575 600 mg ramp up arm |
| APG2575 800 mg arm | EXPERIMENTAL | APG2575 800 mg arm ramp up |
| Name | Type | Description |
|---|---|---|
| APG2575 400 mg | DRUG | APG2575 400 mg |
| APG2575 600 mg | DRUG | APG2575 600 mg |
| APG2575 800 mg | DRUG | APG2575 800 mg |
Inclusion Criteria: * Criteria for inclusion: Patients must meet all of the following inclusion criteria to be eligible for participation in this study: 1. Local confirmed clinicopathological diagnosis of WM in accordance with the consensus panel of the Second International Workshop on WM (Owen 2...
APG-2575, also known as Lisaftoclax, is an investigational small molecule being studied for several conditions, including Acute Myeloid Leukemia, Systemic Lupus Erythematosus (SLE), Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia, and other hematologic malignancies. It is also being evaluated in pharmacokinetic studies.
APG-2575 is a small molecule that targets B-cell lymphoma 2 (BCL-2), a protein that helps cancer cells survive. By inhibiting BCL-2, APG-2575 is designed to induce apoptosis, or programmed cell death, in malignant cells. This mechanism is being explored in hematologic malignancies and autoimmune conditions like SLE.
APG-2575 is being developed by Ascentage Pharma Group International, which trades under the ticker AAPG. The company is conducting clinical trials for this investigational drug across multiple indications, including Acute Myeloid Leukemia and Waldenstrom Macroglobulinemia.
APG-2575 is in Phase 3 clinical development for Acute Myeloid Leukemia, as part of a pivotal study. It has also completed Phase 1 trials for Waldenstrom Macroglobulinemia and pharmacokinetics, and is currently recruiting for a Phase 1 study in Systemic Lupus Erythematosus.
APG-2575 is being studied in several clinical trials. NCT06389292 is a Phase 3 trial combining APG-2575 with azacitidine for Acute Myeloid Leukemia. NCT06182969 is a Phase 1 trial for SLE. Completed trials include NCT04260217 for Waldenstrom Macroglobulinemia and NCT05517616 for pharmacokinetics.
Yes, APG-2575 is also known as Lisaftoclax. The drug is referred to by both names in clinical research, with Lisaftoclax being the generic name. It is an investigational BCL-2 inhibitor being developed by Ascentage Pharma for various cancers and autoimmune diseases.