A study to evaluate the efficacy of APG-2575 (Lisaftoclax) plus azacitidine (AZA) vs. placebo plus AZA in newly diagnosed adult subjects with higher risk myelodysplastic syndrome (Higher Risk-MDS).

Phase 3

Recruiting

• Conditions: Newly Diagnosed Higher Risk Myelodysplastic Syndrome

• Registration Number: 2024-517247-31-00
• Lead Sponsor: Ascentage Pharma Group Inc.

Brief Summary

To evaluate the efficacy of xxx

Detailed Description

This study intends to enroll patients with HR-MDS to receive the therapy of Lisaftoclax (APG-2575) combined with azacitidine (AZA) or placebo combined with azacitidine.

Study Timeline

• Study First Submitted: 2024-10-12
• Study First Submitted QC: 2024-10-12
• Study First Posted: 2024-10-15
• Study Start: 2025-01-22
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-13
• Last Update Posted: 2025-10-15
• Primary Completion: 2029-06
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

1. Newly diagnosed higher-risk MDS.
2. ECOG score of ≤2.
3. Expected survival ≥ 3 months.
4. Adequate organ function.
5. Female subjects of potential childbearing potential have a negative urine or serum pregnancy test before dosing. Subjects of childbearing potential as well as their partners voluntarily use contraception deemed effective by the investigator during the treatment period and for at least six months after the last dose of study drug.
6. Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of any trial-specified study procedures.
7. Subjects are able to complete study procedures and follow-up examinations.

Exclusion Criteria

1. Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent.
2. Have undergone hematopoietic stem cell transplantation.
3. Uncontrolled active infection
4. Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.
5. MDS or other conditions that cannot be administered enterally.
6. Any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
xxx		xxx

Secondary Outcome Measures

Name	Time	Method
To evaluate the population pharmacokinetics (Pop PK) following treatment with xxx		To evaluate the population pharmacokinetics (Pop PK) following treatment with xxx
To compare the efficacy of xxx		To compare the efficacy of xxx
To evaluate the safety of xxx		To evaluate the safety of xxx
To evaluate Health Economics Outcomes Research (HEOR) measures of lisaftoclax xxx based on EuroQol 5 Dimension (EQ-5D).		To evaluate Health Economics Outcomes Research (HEOR) measures of lisaftoclax xxx based on EuroQol 5 Dimension (EQ-5D).

Trial Locations

Locations (2)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Peking University People's Hospital; 🇨🇳 Beijing, Beijing Municipality, China