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Clinical Trials in the UK / NCT06423911
Recruiting Phase 3

Study of Olverembatinib (HQP1351) in Patients With CML-CP

NCT06423911 · tracked via the Priya Life Science UK tracker
Sponsor
Ascentage Pharma Group Inc.
Phase
Phase 3
Started
2024-02-05
Last updated
2026-09-15

Condition(s) studied

Chronic Myeloid LeukemiaCMLCML, Chronic Phase

Investigational drug(s) / intervention(s)

olverembatinibBosutinib

olverembatinib: olverembatinib QOD

Bosutinib: Bosutnib QD

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (163)

FacilityCityRegionStatus
Ascentage Investigative Site #1044 Birmingham Alabama Recruiting
Ascentage Investigative Site #1112 Anchorage Alaska Recruiting
Ascentage Investigative Site #1111 Goodyear Arizona Recruiting
Ascentage Investigative Site #1062 Duarte California Recruiting
Ascentage Investigative Site #1099 Irvine California Recruiting
Ascentage Investigative Site #1075 La Jolla California Recruiting
Ascentage Investigative Site #1100 Long Beach California Recruiting
Ascentage Investigative Site #1059 Los Angeles California Recruiting
Ascentage Investigative Site #1121 Sacramento California Recruiting
Ascentage Investigative Site #1109 Upland California Recruiting
Ascentage Investigative Site #1045 Augusta Georgia Recruiting
Ascentage Investigative Site #1110 Newnan Georgia Recruiting
Ascentage Investigative Site #1055 Chicago Illinois Recruiting
Ascentage Investigative Site #1095 Decatur Illinois Recruiting
Ascentage Investigative Site #1069 Indianapolis Indiana Recruiting
Ascentage Investigative Site #1065 Wichita Kansas Recruiting
Ascentage Investigative Site #1084 Lexington Kentucky Recruiting
Ascentage Investigative Site #1058 Louisville Kentucky Recruiting
Ascentage Investigative Site #1801 Baltimore Maryland Recruiting
Ascentage Investigative Site #1056 Detroit Michigan Recruiting
Ascentage Investigative Site #1023 Detroit Michigan Recruiting
Ascentage Investigative Site #1088 St Louis Missouri Recruiting
Ascentage Investigative Site #1097 Lincoln Nebraska Not Yet Recruiting
Ascentage Investigative Site #1066 Las Vegas Nevada Recruiting
Ascentage Investigative Site #1113 Reno Nevada Recruiting
Ascentage Investigative Site #1064 Hackensack New Jersey Recruiting
Ascentage Investigative Site #1054 Morristown New Jersey Recruiting
Ascentage Investigative Site #1098 New Brunswick New Jersey Recruiting
Ascentage Investigative Site #1072 Albuquerque New Mexico Recruiting
Ascentage Investigative Site #1068 Rochester New York Recruiting
Ascentage Investigative Site #1053 Shirley New York Recruiting
Ascentage Investigative Site #1160 Stony Brook New York Not Yet Recruiting
Ascentage Investigative Site #1019 Greenville North Carolina Not Yet Recruiting
Ascentage Investigative Site #1043 Morrisville North Carolina Recruiting
Ascentage Investigative Site #1173 Cleveland Ohio Not Yet Recruiting
Ascentage Investigative Site #1096 Cleveland Ohio Not Yet Recruiting
Ascentage Investigative Site #1174 Mayfield Heights Ohio Not Yet Recruiting
Ascentage Investigative Site #1139 Portland Oregon Not Yet Recruiting
Ascentage Investigative Site #1057 Philadelphia Pennsylvania Recruiting
Ascentage Investigative Site #1022 Pittsburgh Pennsylvania Recruiting

+ 123 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06423911 on ClinicalTrials.gov ↗ ← All trials in the UK