Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as APG2575, APG-2575(Lisaftoclax )
APG-2575 · 7 trials · 7 indications
The primary endpoint was overall survival (OS), defined as the time from the date of randomization to the date of death of any cause.
ORR is defined by Complete Remission (CR)+ CR with incomplete marrow recovery (CRi) + Partial Remission (PR) (according to NCI-WG CLL(2018)) and by CR+PR ( according to Lugano (2014)).Response will be evaluated every 2 cycles (8 weeks) till complete treatment or one month after last dose.
According to CTCAE v5.0, the number and frequency of adverse events of test drug were assessed.
Use liquid scintillation counter to evaluate Radioactivity concentration of each blood and plasma sample.
Use liquid scintillation counter to evaluate Radioactivity concentration of each sample.
To elucidate the pathways of biotransformation.
Adverse events (AE) and serious adverse events (SAE) will be graded according to NCI CTCAE Version 5.0.
ORR is defined by CR+ CRi + PR(according to NCI-WG CLL(2008)) and by CR+PR ( according to NHL Cheson (2007)).Response will be evaluated every 2 cycles (8 weeks) till complete 6 cycles treatment or one month after last dose.
DLT will be graded according to NCI CTCAE Version 5.0. DLT will be defined as clinically significant drug-related adverse events during the cycle one.
MTD/RP2D will be determined based on DLTs observed during cycle one.
Patients with APG-2575 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 5.0
| Arm | Type | Description |
|---|---|---|
| APG-2575 (Lisaftoclax) combined with Azacitidine | EXPERIMENTAL | - |
| Placebo combined with Azacitidine | ACTIVE_COMPARATOR | - |
| APG-2575 single agent in Relapse/Refractory CLL/SLL | EXPERIMENTAL | APG-2575 orally once daily at 600mg dose levels, every 28 days as a cycle. |
| APG-2575 | EXPERIMENTAL | Dose escalation |
| Placebo | PLACEBO_COMPARATOR | - |
| [14C]APG-2575 | EXPERIMENTAL | To investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose of 400mg, 200μCi \[14C\] APG-2575 to healthy subjects. |
| APG-2575+Rituximab in Relapse/Refractory CLL/SLL | EXPERIMENTAL | Stage 1:APG-2575 orally once daily starting from 200mg and will be increased in subsequent cohorts to 400mg, 600mg, 800mg. Rituximab 375mg/m2 ivgtt on C1D8 and 500mg/m2 ivgtt on C2-6D1. Every 28 days as a cycle. Stage 2: APG-2575 MTD/RP2D combined with rituximab. Every 28 days as a cycle. |
| APG-2575+ibrutinib in Relapse/Refractory CLL/SLL | EXPERIMENTAL | Stage 1: APG-2575 orally once daily starting from 200mg and will be increased in subsequent cohorts to 400mg, 600mg, 800mg.Ibrutinib 420mg orally once daily during C1D8-28 and following cycles. Every 28 days as a cycle. Stage 2: APG-2575 MTD/RP2D combined with ibrutinib. Every 28 days as a cycle. |
| single-agent, open-label, Phase I study of APG-2575 | EXPERIMENTAL | The study consists of the dose escalation stage and the dose expansion stage |
| Name | Type | Description |
|---|---|---|
| APG-2575(Lisaftoclax ) | DRUG | QD, oral administration, every 28 days for a dosing cycle. |
| Placebo | OTHER | QD, oral administration, every 28 days for a dosing cycle. |
| Azacitidine Injection | DRUG | QD, subcutaneous or intravenous injection, D1-7 in 28-day cycle. |
| APG2575 | DRUG | APG-2575 orally once daily at 600mg dose levels, every 28 days as a cycle. |
| APG-2575 | DRUG | Take orally once daily (QD) for 12 weeks. |
| [14C ]APG-2575 | DRUG | orally, single dose of 400 mg / 200 μCi \[14C\] APG-2575 |
| Rituximab | DRUG | Rituximab 375mg/m2 ivgtt on C1D8 and 500mg/m2 ivgtt on C2-6D1. |
| Ibrutinib | DRUG | Ibrutinib 420mg orally once daily during C1D8-28 and following cycles. |
Inclusion Criteria: 1. Patients must have newly diagnosed AML that meets the criteria for acute myeloid leukemia (AML) and ineligible for standard chemotherapy. 2. Life expectancy of ≥3 months. 3. Be able to accept oral administration. 4. Patients aged ≥70 years with ECOG score of 0-2, or those age...
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.