RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Ascentage Pharma Group Inc. • ClinicalTrials.gov ID: NCT06423911

Registry updated: 2026-09-15

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Description

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.

Interventions

olverembatinib (Drug)
olverembatinib QOD
Bosutinib (Drug)
Bosutnib QD

Eligibility criteria

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

Conditions

Chronic Myeloid Leukemia CML CML, Chronic Phase

Locations

Ascentage Investigative Site #1044 — Birmingham, Alabama, United States
Ascentage Investigative Site #1112 — Anchorage, Alaska, United States
Ascentage Investigative Site #1111 — Goodyear, Arizona, United States
Ascentage Investigative Site #1062 — Duarte, California, United States
Ascentage Investigative Site #1099 — Irvine, California, United States
Ascentage Investigative Site #1075 — La Jolla, California, United States
Ascentage Investigative Site #1100 — Long Beach, California, United States
Ascentage Investigative Site #1059 — Los Angeles, California, United States
Ascentage Investigative Site #1121 — Sacramento, California, United States
Ascentage Investigative Site #1109 — Upland, California, United States
Ascentage Investigative Site #1045 — Augusta, Georgia, United States
Ascentage Investigative Site #1110 — Newnan, Georgia, United States
Ascentage Investigative Site #1055 — Chicago, Illinois, United States
Ascentage Investigative Site #1095 — Decatur, Illinois, United States
Ascentage Investigative Site #1069 — Indianapolis, Indiana, United States
Ascentage Investigative Site #1065 — Wichita, Kansas, United States
Ascentage Investigative Site #1084 — Lexington, Kentucky, United States
Ascentage Investigative Site #1058 — Louisville, Kentucky, United States
Ascentage Investigative Site #1801 — Baltimore, Maryland, United States
Ascentage Investigative Site #1056 — Detroit, Michigan, United States
Ascentage Investigative Site #1023 — Detroit, Michigan, United States
Ascentage Investigative Site #1088 — St Louis, Missouri, United States
Ascentage Investigative Site #1097 — Lincoln, Nebraska, United States
Ascentage Investigative Site #1066 — Las Vegas, Nevada, United States
Ascentage Investigative Site #1113 — Reno, Nevada, United States
Ascentage Investigative Site #1064 — Hackensack, New Jersey, United States
Ascentage Investigative Site #1054 — Morristown, New Jersey, United States
Ascentage Investigative Site #1098 — New Brunswick, New Jersey, United States
Ascentage Investigative Site #1072 — Albuquerque, New Mexico, United States
Ascentage Investigative Site #1068 — Rochester, New York, United States
Ascentage Investigative Site #1053 — Shirley, New York, United States
Ascentage Investigative Site #1160 — Stony Brook, New York, United States
Ascentage Investigative Site #1019 — Greenville, North Carolina, United States
Ascentage Investigative Site #1043 — Morrisville, North Carolina, United States
Ascentage Investigative Site #1173 — Cleveland, Ohio, United States
Ascentage Investigative Site #1096 — Cleveland, Ohio, United States
Ascentage Investigative Site #1174 — Mayfield Heights, Ohio, United States
Ascentage Investigative Site #1139 — Portland, Oregon, United States
Ascentage Investigative Site #1057 — Philadelphia, Pennsylvania, United States
Ascentage Investigative Site #1022 — Pittsburgh, Pennsylvania, United States
Ascentage Investigative Site #1063 — Chattanooga, Tennessee, United States
Ascentage Investigative Site #1089 — Nashville, Tennessee, United States
Ascentage Investigative Site #1051 — Amarillo, Texas, United States
Ascentage Investigative Site #1036 — Austin, Texas, United States
Ascentage Investigative Site #1501 — Houston, Texas, United States
Ascentage Investigative Site #1050 — Virginia Beach, Virginia, United States
Ascentage Investigative Site #1136 — Edmonds, Washington, United States
Ascentage Investigative Site #1135 — Issaquah, Washington, United States
Ascentage Investigative Site #1806 — Seattle, Washington, United States
Ascentage Investigative Site #1510 — Seattle, Washington, United States
Ascentage Investigative Site #2107 — Campbelltown, New South Wales, Australia
Ascentage Investigative Site #2105 — Liverpool, New South Wales, Australia
Ascentage Investigative Site #2115 — Adelaide, South Australia, Australia
Ascentage Investigative Site #2106 — Perth, Western Australia, Australia
Ascentage Investigative Site #5211 — Anderlecht, Belgium
Ascentage Investigative Site #5212 — Gilly, Belgium
Ascentage Investigative Site #5208 — Kortrijk, Belgium
Ascentage Investigative Site #5209 — Roeselare, Belgium
Ascentage Investigative Site #5210 — Yvoir, Belgium
Ascentage Investigative Site #8004 — Toronto, Canada
Ascentage Investigative Site #5037 — Amiens, France
Ascentage Investigative Site #5015 — Bobigny, France
Ascentage Investigative Site #5017 — Nice, France
Ascentage Investigative Site #5016 — Rouen, France
Ascentage Investigative Site #5023 — Toulouse, France
Ascentage Investigative Site #5708 — Berlin, Germany
Ascentage Investigative Site #5709 — Dresden, Germany
Ascentage Investigative Site #9118 — Bangalore, India
Ascentage Investigative Site #9120 — Haryāna, India
Ascentage Investigative Site #9102 — Haryāna, India
Ascentage Investigative Site #9110 — Hyderabad, India
Ascentage Investigative Site #9116 — Kolkata, India
Ascentage Investigative Site #9115 — Kolkata, India
Ascentage Investigative Site #9101 — New Delhi, India
Ascentage Investigative Site #9103 — New Delhi, India
Ascentage Investigative Site #9119 — Pune, India
Ascentage Investigative Site #9113 — Thiruvananthapuram, India
Ascentage Investigative Site #5535 — Bologna, Italy
Ascentage Investigative Site #5534 — Candiolo, Italy
Ascentage Investigative Site #5527 — Catania, Italy
Ascentage Investigative Site #5523 — Lecce, Italy
Ascentage Investigative Site #5529 — Meldola, Italy
Ascentage Investigative Site #5537 — Messina, Italy
Ascentage Investigative Site #5553 — Milan, Italy
Ascentage Investigative Site #5530 — Naples, Italy
Ascentage Investigative Site #5524 — Novara, Italy
Ascentage Investigative Site #5525 — Padova, Italy
Ascentage Investigative Site #5526 — Pisa, Italy
Ascentage Investigative Site #5528 — Roma, Italy
Ascentage Investigative Site #5522 — Roma, Italy
Ascentage Investigative Site #5510 — Roma, Italy
Ascentage Investigative Site #5552 — Torino, Italy
Ascentage Investigative Site #5521 — Torino, Italy
Ascentage Investigative Site #5536 — Varese, Italy
Ascentage Investigative Site #8101 — Ehime, Japan
Ascentage Investigative Site #8102 — Kyoto, Japan
Ascentage Investigative Site #8112 — Okayama, Japan
Ascentage Investigative Site #8105 — Osaka, Japan
Ascentage Investigative Site #8106 — Sapporo, Japan
Ascentage Investigative Site #8107 — Sapporo, Japan
Ascentage Investigative Site #8109 — Tochigi, Japan
Ascentage Investigative Site #8114 — Tokyo, Japan
Ascentage Investigative Site #8117 — Tokyo, Japan
Ascentage Investigative Site #8110 — Tokyo, Japan
Ascentage Investigative Site #8104 — Yamagata, Japan
Ascentage Investigative Site #8103 — Yamanashi, Japan
Ascentage Investigative Site #4213 — Gdansk, Poland
Ascentage Investigative Site #4212 — Gdansk, Poland
Ascentage Investigative Site #4207 — Katowice, Poland
Ascentage Investigative Site #4209 — Krakow, Poland
Ascentage Investigative Site #4211 — Lodz, Poland
Ascentage Investigative Site #4214 — Torun, Poland
Ascentage Investigative Site #4206 — Warsaw, Poland
Ascentage Investigative Site #4210 — Wałbrzych, Poland
Ascentage Investigative Site #3227 — Moscow, Russia
Ascentage Investigative Site #3228 — Saint Petersburg, Russia
Ascentage Investigative Site #3213 — Saint Petersburg, Russia
Ascentage Investigative Site #3212 — Saint Petersburg, Russia
Ascentage Investigative Site #6602 — Singapore, Singapore
Ascentage Investigative Site #6601 — Singapore, Singapore
Ascentage Investigative Site #8206 — Busan, South Korea
Ascentage Investigative Site #8207 — Busan, South Korea
Ascentage Investigative Site #8204 — Gyeonggi-do, South Korea
Ascentage Investigative Site #8201 — Seoul, South Korea
Ascentage Investigative Site #8202 — Seoul, South Korea
Ascentage Investigative Site #8205 — Seoul, South Korea
Ascentage Investigative Site #8203 — Seoul, South Korea
Ascentage Investigative Ste #8208 — Uijeongbu-si, South Korea
Ascentage Investigative Site #6015 — Badalona, Spain
Ascentage Investigative Site #6020 — Barcelona, Spain
Ascentage Investigative Site #6047 — Elche, Spain
Ascentage Investigative Site #6014 — L'Hospitalet de Llobregat, Spain
Ascentage Investigative Site #6035 — Madrid, Spain
Ascentage Investigative Site #6013 — Madrid, Spain
Ascentage Investigative Site #6033 — Madrid, Spain
Ascentage Investigative Site #6011 — Madrid, Spain
Ascentage Investigative Site #6032 — Madrid, Spain
Ascentage Investigative Site #6037 — Majadahonda, Spain
Ascentage Investigative Site #6012 — Málaga, Spain
Ascentage Investigative Site #6039 — Málaga, Spain
Ascentage Investigative Site #6051 — Murcia, Spain
Ascentage Investigative Site #6036 — Ourense, Spain
Ascentage Investigative Site #6038 — Valencia, Spain
Ascentage Investigative Site #6041 — Zaragoza, Spain
Ascentage Investigative Site #9216 — Adapazarı, Turkey (Türkiye)
Ascentage Investigative Site #9218 — Ankara, Turkey (Türkiye)
Ascentage Investigative Site #9204 — Ankara, Turkey (Türkiye)
Ascentage Investigative Site #9215 — Battalgazi, Turkey (Türkiye)
Ascentage Investigative Site #9217 — Çankaya, Turkey (Türkiye)
Ascentage Investigative Site #9219 — Istanbul, Turkey (Türkiye)
Ascentage Investigative Site #9205 — Kepez, Turkey (Türkiye)
Ascentage Investigative Site #9208 — Mezitli, Turkey (Türkiye)
Ascentage Investigative Site #9213 — Ortahisar, Turkey (Türkiye)
Ascentage Investigative Site #9214 — Samsun, Turkey (Türkiye)
Ascentage Investigative Site #9212 — Yenimahalle, Turkey (Türkiye)
Ascentage Investigative Site #7017 — Aberdeen, United Kingdom
Ascentage Investigative Site #7036 — Birmingham, United Kingdom
Ascentage Investigative Site #7021 — Boston, United Kingdom
Ascentage Investigative Site #7037 — Bradford, United Kingdom
Ascentage Investigative Site #7035 — Liverpool, United Kingdom
Ascentage Investigative Site #7016 — London, United Kingdom
Ascentage Investigative Site #7015 — London, United Kingdom
Ascentage Investigative Site #7018 — Newport, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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