Trials / Recruiting
RecruitingNCT04501120
Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML
A Phase Ib Study of the Safety, Pharmacokinetic of Lisaftoclax (APG-2575) Single Agent and in Combination With Homoharringtonine or Azacitidine in Patients With Relapsed/Refractory AML
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 458 (estimated)
- Sponsor
- Ascentage Pharma Group Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety, pharmacokinetic profile of Lisaftoclax (APG-2575) single agent and in combination with HHT/AZA in patients with relapsed/refractory AML and related myeloid malignancies.
Detailed description
This is an open-label, multi-center Phase Ib study of safety, PK of Lisaftoclax (APG-2575) as single agent or in combination with HHT or AZA in relapsed/refractory AML and related myeloid malignancies patients. This study consists of three stages: The first stage is the Lisaftoclax (APG-2575) single agent dose-escalation study. The second stage is the Lisaftoclax (APG-2575) combined with HHT/AZA dose-escalation study. The third stage is the MTD/RP2D expansion cohort study of the combination regimen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lisaftoclax (APG-2575) | Lisaftoclax (APG-2575) orally once daily, every 28 days as a cycle. |
| DRUG | Reduced-dose HHT | 1mg IV QD on Days 1-14 (28-day cycle). |
| DRUG | standard-dose HHT | 2mg/m\^2 IV QD on Days 1-7 (28-day cycle). |
| DRUG | Azacitidine | 75 mg/m\^2 SC or Iv gtt QD on Days 1- 7 (28-day cycle). |
| DRUG | Lisaftoclax (APG-2575) | Lisaftoclax (APG-2575) orally once daily for 14 days, every 28 days as a cycle. |
| DRUG | olverembatinib | orally, with meals, QOD, every 28 days as a cycle. |
Timeline
- Start date
- 2020-09-28
- Primary completion
- 2028-09-01
- Completion
- 2029-09-01
- First posted
- 2020-08-06
- Last updated
- 2025-09-26
Locations
12 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04501120. Inclusion in this directory is not an endorsement.