Recruiting
Phase 3

Lisaftoclax & Azacitidine

Sponsor:

Ascentage Pharma Group Inc.

Code:

NCT06641414

Conditions

Higher-risk Myelodysplastic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lisaftoclax (APG-2575)

Azacitidine Injection

Placebo

Study Details

Brief summary:

A global multicenter, randomized, double-blind, placebo-controlled, pivotal phase III study. To evaluate overall survival (OS) of Lisaftoclax (APG-2575) combined with azacitidine (AZA) vs. placebo combined with azacitidine in newly diagnosed patients with HR-MDS.

Conditions

Higher-risk Myelodysplastic Syndrome

Study ID

NCT06641414

Start date

Jan 22, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

490 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lisaftoclax (APG-2575) combined with Azacitidine

active comparator: Placebo combined with Azacitidine

Interventions

Lisaftoclax (APG-2575)

QD, oral administration.

Azacitidine Injection

QD, hypodermic or intravenous injection.

Placebo

QD, oral administration.

Primary outcome measure

  • Overall Survival(OS) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77054

Contacts

Guillermo Garcia-Manero, M.D.

713-745-3428ggarciam@mdanderson.org

Principal Investigator:

Guillermo Garcia-Manero, M.D.

More Information

Sponsor

Ascentage Pharma Group Inc.

Last update posted

Nov 20, 2025

Last verified

Nov, 2025

Keywords

  • Higher-risk Myelodysplastic Syndrome
  • Lisaftoclax

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ascentage Pharma Group Inc. on 2025-11-20.