Recruiting
Phase 3

Olverembatinib

Sponsor:

Ascentage Pharma Group Inc.

Code:

NCT06423911

Conditions

Chronic Myeloid Leukemia

CML

CML, Chronic Phase

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

olverembatinib

Bosutinib

Study Details

Brief summary:

Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B).

Patients who meet ELN 2025 failure criteria while receiving bosutinib in Part A may be able to receive olverembatinib in crossover follow-on study.

Conditions

Chronic Myeloid Leukemia

CML

CML, Chronic Phase

Study ID

NCT06423911

Start date

Feb 5, 2024

Status verified date

Sep, 2026

Completion date

Jul 10, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

Patients eligible for inclusion in this study must meet all of the following criteria:

1. Age ≥ 18 years old
2. Diagnosis of CML-CP
3. Part A: Previously treated with at least two approved TKIs; Part B: T315I mutation at screening and previously treated with at least one approved TKI, with no other effective and/or tolerable therapies available
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
5. Patient has adequate organ function

Exclusion Criteria

Patients eligible for this study must not meet any of the following criteria:

1. For Part A only: T315I or V299L mutation at any time prior to starting study treatment
2. Active infection that requires systemic drug therapy
3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients
5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients
6. Pregnant or nursing (lactating) women

Study Design

Enrollment

333 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Part A, RCT, olverembatinib arm and bosutinib arm

Randomized controlled part that is designed to compare the efficacy and safety of olverembatinib (investigational arm) versus bosutinib (control arm) in patients with CML-CP, previously treated with at least two TKIs

other: Part B, SAT, olverembatinib arm

To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously

Interventions

olverembatinib

olverembatinib QOD

Bosutinib

Bosutnib QD

Primary outcome measure

  • 24-Week MMR Rate (Part A) [ Time Frame: 24 weeks ]
  • 24-Week MMR Rate (Part B) [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Ascentage Clinical Operations

301-291-5658clinical-trials@ascentage.com

Locations

Ascentage Investigative Site #1044

Recruiting

Birmingham, Alabama, United States, 35249

Ascentage Investigative Site #1112

Recruiting

Anchorage, Alaska, United States, 99508

Ascentage Investigative Site #1111

Recruiting

Goodyear, Arizona, United States, 85338

Ascentage Investigative Site #1062

Recruiting

Duarte, California, United States, 91010

Ascentage Investigative Site #1099

Recruiting

Irvine, California, United States, 92618

Ascentage Investigative Site #1075

Recruiting

La Jolla, California, United States, 92037

Ascentage Investigative Site #1100

Recruiting

Long Beach, California, United States, 90813

Ascentage Investigative Site #1059

Recruiting

Los Angeles, California, United States, 90024

Ascentage Investigative Site #1121

Recruiting

Sacramento, California, United States, 95817

Ascentage Investigative Site #1109

Recruiting

Upland, California, United States, 91786

Ascentage Investigative Site #1045

Recruiting

Augusta, Georgia, United States, 30912

Ascentage Investigative Site #1110

Recruiting

Newnan, Georgia, United States, 30265

Ascentage Investigative Site #1055

Recruiting

Chicago, Illinois, United States, 60637

Ascentage Investigative Site #1095

Recruiting

Decatur, Illinois, United States, 62526

Ascentage Investigative Site #1069

Recruiting

Indianapolis, Indiana, United States, 46237

Ascentage Investigative Site #1065

Recruiting

Wichita, Kansas, United States, 67214

Ascentage Investigative Site #1084

Recruiting

Lexington, Kentucky, United States, 40536

Ascentage Investigative Site #1058

Recruiting

Louisville, Kentucky, United States, 40202

Ascentage Investigative Site #1801

Recruiting

Baltimore, Maryland, United States, 21201

Ascentage Investigative Site #1056

Recruiting

Detroit, Michigan, United States, 48201

Ascentage Investigative Site #1023

Recruiting

Detroit, Michigan, United States, 49254

Ascentage Investigative Site #1088

Recruiting

St Louis, Missouri, United States, 63108

Ascentage Investigative Site #1066

Recruiting

Las Vegas, Nevada, United States, 89169

Ascentage Investigative Site #1113

Recruiting

Reno, Nevada, United States, 89511

Ascentage Investigative Site #1064

Recruiting

Hackensack, New Jersey, United States, 07601

Ascentage Investigative Site #1054

Recruiting

Morristown, New Jersey, United States, 07960

Ascentage Investigative Site #1098

Recruiting

New Brunswick, New Jersey, United States, 08901

Ascentage Investigative Site #1072

Recruiting

Albuquerque, New Mexico, United States, 87102

Ascentage Investigative Site #1068

Recruiting

Rochester, New York, United States, 14642

Ascentage Investigative Site #1053

Recruiting

Shirley, New York, United States, 11967

Ascentage Investigative Site #1043

Recruiting

Morrisville, North Carolina, United States, 27560

Ascentage Investigative Site #1057

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Ascentage Investigative Site #1022

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Ascentage Investigative Site #1063

Recruiting

Chattanooga, Tennessee, United States, 37404

Ascentage Investigative Site #1089

Recruiting

Nashville, Tennessee, United States, 37203

Ascentage Investigative Site #1051

Recruiting

Amarillo, Texas, United States, 79124

Ascentage Investigative Site #1036

Recruiting

Austin, Texas, United States, 78705

Ascentage Investigative Site #1501

Recruiting

Houston, Texas, United States, 77030

Ascentage Investigative Site #1050

Recruiting

Virginia Beach, Virginia, United States, 23456

Ascentage Investigative Site #1136

Recruiting

Edmonds, Washington, United States, 98026

Ascentage Investigative Site #1135

Recruiting

Issaquah, Washington, United States, 98029

Ascentage Investigative Site #1806

Recruiting

Seattle, Washington, United States, 98104

Ascentage Investigative Site #1510

Recruiting

Seattle, Washington, United States, 98109

Ascentage Investigative Site #8004

Recruiting

Toronto, Canada, M5G 2M9

More Information

Sponsor

Ascentage Pharma Group Inc.

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

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 2026-09-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.