Recruiting

Phase 3

Lisaftoclax & AzacitidineLisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).

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

Oct, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

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. Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.
4. MDS or other conditions that cannot be administered enterally.
5. 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

Drug: azacitidine injection QD: hypodermic or intravenous injection

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

Yifan Zhai, M.D., Ph.D.

+86-20-28068501 yzhai@ascentage.com

Qian Niu, M.D.

Qian.Niu@ascentage.com

Locations

Ascentage Investigative Site

Recruiting

Phoenix, Arizona, United States, 85054

Ascentage Investigative Site

Recruiting

Los Angeles, California, United States, 90095

Ascentage Investigative Site

Recruiting

Sacramento, California, United States, 95817

Ascentage Investigative Site

Recruiting

San Diego, California, United States, 92093

Ascentage Investigative Site

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Aurora, Colorado, United States, 80045

Ascentage Investigative Site

Recruiting

Jacksonville, Florida, United States, 32224

Ascentage Investigative Site

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Chicago, Illinois, United States, 60611

Ascentage Investigative Site

Recruiting

Indianapolis, Indiana, United States, 46237

Ascentage Investigative Site

Recruiting

Louisville, Kentucky, United States, 40202

Ascentage Investigative Site

Recruiting

Baltimore, Maryland, United States, 21201-1595

Ascentage Investigative Site

Recruiting

Minneapolis, Minnesota, United States, 55455

Ascentage Investigative Site

Recruiting

Rochester, Minnesota, United States, 55905

Ascentage Investigative Site

Recruiting

St Louis, Missouri, United States, 63110

Ascentage Investigative Site

Recruiting

Lincoln, Nebraska, United States, 68506

Ascentage Investigative Site

Recruiting

Hackensack, New Jersey, United States, 07601

Ascentage Investigative Site

Recruiting

New York, New York, United States, 10065

Ascentage Investigative Site

Recruiting

Rochester, New York, United States, 14642

Ascentage Investigative Site

Recruiting

The Bronx, New York, United States, 10467

Ascentage Investigative Site

Recruiting

Charlotte, North Carolina, United States, 28204

Ascentage Investigative Site

Recruiting

Durham, North Carolina, United States, 27705

Ascentage Investigative Site

Recruiting

Winston-Salem, North Carolina, United States, 27103

Ascentage Investigative Site

Recruiting

Cleveland, Ohio, United States, 44195

Ascentage Investigative Site

Recruiting

Columbus, Ohio, United States, 43210

Ascentage Investigative Site

Recruiting

Eugene, Oregon, United States, 97401

Ascentage Investigative Site

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Ascentage Investigative Site

Recruiting

Austin, Texas, United States, 78705

Ascentage Investigative Site

Recruiting

Houston, Texas, United States, 77054

Principal Investigator:

Guillermo Garcia-Manero, M.D.

Ascentage Investigative Site

Recruiting

Tyler, Texas, United States, 75702

Ascentage Investigative Site

Recruiting

Charlottesville, Virginia, United States, 22908

Ascentage Investigative Site

Recruiting

Manassas, Virginia, United States, 20110

Ascentage Investigative Site

Recruiting

Norfolk, Virginia, United States, 23502

Ascentage Investigative Site

Recruiting

Edmonds, Washington, United States, 98026

Ascentage Investigative Site

Recruiting

Issaquah, Washington, United States, 98104

Ascentage Investigative Site

Recruiting

Seattle, Washington, United States, 98104

Ascentage Investigative Site

Recruiting

Seattle, Washington, United States, 98109

Ascentage Investigative Site

Recruiting

Milwaukee, Wisconsin, United States, 53266

Ascentage Investigative Site

Recruiting

Waukesha, Wisconsin, United States, 53188

Ascentage Investigative Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

More Information

Sponsor

Ascentage Pharma Group Inc.

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

Higher-risk Myelodysplastic Syndrome
Lisaftoclax

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Ascentage Pharma Group Inc. on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.