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NCT06423911PHASE3Recruiting

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

Ascentage Pharma Group Inc.

Start Date

2/5/2024

Completion Date

7/10/2028

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

olverembatinib

DRUG

Bosutinib

Interested in This Trial?

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Conditions

Chronic Myeloid LeukemiaCMLCML, Chronic Phase

Locations

Ascentage Investigative Site #1044

Birmingham, Alabama 35249

United States

Ascentage Investigative Site #1112

Anchorage, Alaska 99508

United States

Ascentage Investigative Site #1111

Goodyear, Arizona 85338

United States

Ascentage Investigative Site #1062

Duarte, California 91010

United States

Ascentage Investigative Site #1099

Irvine, California 92618

United States

Ascentage Investigative Site #1075

La Jolla, California 92037

United States

Ascentage Investigative Site #1100

Long Beach, California 90813

United States

Ascentage Investigative Site #1059

Los Angeles, California 90024

United States

Ascentage Investigative Site #1121

Sacramento, California 95817

United States

Ascentage Investigative Site #1109

Upland, California 91786

United States

Ascentage Investigative Site #1045

Augusta, Georgia 30912

United States

Ascentage Investigative Site #1110

Newnan, Georgia 30265

United States

Ascentage Investigative Site #1055

Chicago, Illinois 60637

United States

Ascentage Investigative Site #1095

Decatur, Illinois 62526

United States

Ascentage Investigative Site #1069

Indianapolis, Indiana 46237

United States

Ascentage Investigative Site #1065

Wichita, Kansas 67214

United States

Ascentage Investigative Site #1084

Lexington, Kentucky 40536

United States

Ascentage Investigative Site #1058

Louisville, Kentucky 40202

United States

Ascentage Investigative Site #1801

Baltimore, Maryland 21201

United States

Ascentage Investigative Site #1056

Detroit, Michigan 48201

United States

Ascentage Investigative Site #1023

Detroit, Michigan 49254

United States

Ascentage Investigative Site #1088

St Louis, Missouri 63108

United States

Ascentage Investigative Site #1097

Lincoln, Nebraska 68506

United States

Ascentage Investigative Site #1066

Las Vegas, Nevada 89169

United States

Ascentage Investigative Site #1113

Reno, Nevada 89511

United States

Ascentage Investigative Site #1064

Hackensack, New Jersey 07601

United States

Ascentage Investigative Site #1054

Morristown, New Jersey 07960

United States

Ascentage Investigative Site #1098

New Brunswick, New Jersey 08901

United States

Ascentage Investigative Site #1072

Albuquerque, New Mexico 87102

United States

Ascentage Investigative Site #1068

Rochester, New York 14642

United States

Ascentage Investigative Site #1053

Shirley, New York 11967

United States

Ascentage Investigative Site #1160

Stony Brook, New York 11794

United States

Ascentage Investigative Site #1019

Greenville, North Carolina 27858

United States

Ascentage Investigative Site #1043

Morrisville, North Carolina 27560

United States

Ascentage Investigative Site #1173

Cleveland, Ohio 44111

United States

Ascentage Investigative Site #1096

Cleveland, Ohio 44195

United States

Ascentage Investigative Site #1174

Mayfield Heights, Ohio 44124

United States

Ascentage Investigative Site #1139

Portland, Oregon 97239

United States

Ascentage Investigative Site #1057

Philadelphia, Pennsylvania 19104

United States

Ascentage Investigative Site #1022

Pittsburgh, Pennsylvania 15232

United States

Ascentage Investigative Site #1063

Chattanooga, Tennessee 37404

United States

Ascentage Investigative Site #1089

Nashville, Tennessee 37203

United States

Ascentage Investigative Site #1051

Amarillo, Texas 79124

United States

Ascentage Investigative Site #1036

Austin, Texas 78705

United States

Ascentage Investigative Site #1501

Houston, Texas 77030

United States

Ascentage Investigative Site #1050

Virginia Beach, Virginia 23456

United States

Ascentage Investigative Site #1136

Edmonds, Washington 98026

United States

Ascentage Investigative Site #1135

Issaquah, Washington 98029

United States

Ascentage Investigative Site #1806

Seattle, Washington 98104

United States

Ascentage Investigative Site #1510

Seattle, Washington 98109

United States

Ascentage Investigative Site #2107

Campbelltown, New South Wales 2560

Australia

Ascentage Investigative Site #2105

Liverpool, New South Wales 2170

Australia

Ascentage Investigative Site #2115

Adelaide, South Australia 5000

Australia

Ascentage Investigative Site #2106

Perth, Western Australia 6000

Australia

Ascentage Investigative Site #5211

Anderlecht, 1070

Belgium

Ascentage Investigative Site #5212

Gilly, 6060

Belgium

Ascentage Investigative Site #5208

Kortrijk, 8500

Belgium

Ascentage Investigative Site #5209

Roeselare, 8800

Belgium

Ascentage Investigative Site #5210

Yvoir, 5530

Belgium

Ascentage Investigative Site #8004

Toronto, M5G 2M9

Canada

Ascentage Investigative Site #5037

Amiens, 80054

France

Ascentage Investigative Site #5015

Bobigny, 93000

France

Ascentage Investigative Site #5017

Nice, 06202

France

Ascentage Investigative Site #5016

Rouen, 76038

France

Ascentage Investigative Site #5023

Toulouse, 31059

France

Ascentage Investigative Site #5708

Berlin, 13353

Germany

Ascentage Investigative Site #5709

Dresden, 01307

Germany

Ascentage Investigative Site #9118

Bangalore, 560027

India

Ascentage Investigative Site #9120

Haryāna, 122002

India

Ascentage Investigative Site #9102

Haryāna, 124105

India

Ascentage Investigative Site #9110

Hyderabad, 500033

India

Ascentage Investigative Site #9116

Kolkata, 700014

India

Ascentage Investigative Site #9115

Kolkata, 700054

India

Ascentage Investigative Site #9101

New Delhi, 110029

India

Ascentage Investigative Site #9103

New Delhi, 110076

India

Ascentage Investigative Site #9119

Pune, 411001

India

Ascentage Investigative Site #9113

Thiruvananthapuram, 695011

India

Ascentage Investigative Site #5535

Bologna, 40138

Italy

Ascentage Investigative Site #5534

Candiolo, 10060

Italy

Ascentage Investigative Site #5527

Catania, 95123

Italy

Ascentage Investigative Site #5523

Lecce, 73100

Italy

Ascentage Investigative Site #5529

Meldola, 47014

Italy

Ascentage Investigative Site #5537

Messina, 98124

Italy

Ascentage Investigative Site #5553

Milan, 20122

Italy

Ascentage Investigative Site #5530

Naples, 80131

Italy

Ascentage Investigative Site #5524

Novara, 28100

Italy

Ascentage Investigative Site #5525

Padova, 35128

Italy

Ascentage Investigative Site #5526

Pisa, 56126

Italy

Ascentage Investigative Site #5528

Roma, 00144

Italy

Ascentage Investigative Site #5522

Roma, 00161

Italy

Ascentage Investigative Site #5510

Roma, 00168

Italy

Ascentage Investigative Site #5552

Torino, 10126

Italy

Ascentage Investigative Site #5521

Torino, 10128

Italy

Ascentage Investigative Site #5536

Varese, 21100

Italy

Ascentage Investigative Site #8101

Ehime, 790-8524

Japan

Ascentage Investigative Site #8102

Kyoto, 602-8566

Japan

Ascentage Investigative Site #8112

Okayama, 701-1192

Japan

Ascentage Investigative Site #8105

Osaka, 565-0871

Japan

Ascentage Investigative Site #8106

Sapporo, 003-0006

Japan

Ascentage Investigative Site #8107

Sapporo, 060-8648

Japan

Ascentage Investigative Site #8109

Tochigi, 321-0207

Japan

Ascentage Investigative Site #8114

Tokyo, 113-8677

Japan

Ascentage Investigative Site #8117

Tokyo, 130-8575

Japan

Ascentage Investigative Site #8110

Tokyo, 141-8625

Japan

Ascentage Investigative Site #8104

Yamagata, 990-9585

Japan

Ascentage Investigative Site #8103

Yamanashi, 409-3898

Japan

Ascentage Investigative Site #4213

Gdansk, 80214

Poland

Ascentage Investigative Site #4212

Gdansk, 80219

Poland

Ascentage Investigative Site #4207

Katowice, 40519

Poland

Ascentage Investigative Site #4209

Krakow, 30688

Poland

Ascentage Investigative Site #4211

Lodz, 93513

Poland

Ascentage Investigative Site #4214

Torun, 87100

Poland

Ascentage Investigative Site #4206

Warsaw, 00791

Poland

Ascentage Investigative Site #4210

Wałbrzych, 58309

Poland

Ascentage Investigative Site #3227

Moscow, 125167

Russia

Ascentage Investigative Site #3228

Saint Petersburg, 191024

Russia

Ascentage Investigative Site #3213

Saint Petersburg, 194291

Russia

Ascentage Investigative Site #3212

Saint Petersburg, 197341

Russia

Ascentage Investigative Site #6602

Singapore, 117599

Singapore

Ascentage Investigative Site #6601

Singapore, 168583

Singapore

Ascentage Investigative Site #8206

Busan, 49201

South Korea

Ascentage Investigative Site #8207

Busan, 49241

South Korea

Ascentage Investigative Site #8204

Gyeonggi-do, 13620

South Korea

Ascentage Investigative Site #8201

Seoul, 03080

South Korea

Ascentage Investigative Site #8202

Seoul, 05505

South Korea

Ascentage Investigative Site #8205

Seoul, 06351

South Korea

Ascentage Investigative Site #8203

Seoul, 06591

South Korea

Ascentage Investigative Ste #8208

Uijeongbu-si, 11749

South Korea

Ascentage Investigative Site #6015

Badalona, 08916

Spain

Ascentage Investigative Site #6020

Barcelona, 08035

Spain

Ascentage Investigative Site #6047

Elche, 03293

Spain

Ascentage Investigative Site #6014

L'Hospitalet de Llobregat, 08906

Spain

Ascentage Investigative Site #6035

Madrid, 28006

Spain

Ascentage Investigative Site #6013

Madrid, 28007

Spain

Ascentage Investigative Site #6033

Madrid, 28031

Spain

Ascentage Investigative Site #6011

Madrid, 28041

Spain

Ascentage Investigative Site #6032

Madrid, 28046

Spain

Ascentage Investigative Site #6037

Majadahonda, 28222

Spain

Ascentage Investigative Site #6012

Málaga, 29010

Spain

Ascentage Investigative Site #6039

Málaga, 29010

Spain

Ascentage Investigative Site #6051

Murcia, 30120

Spain

Ascentage Investigative Site #6036

Ourense, 32005

Spain

Ascentage Investigative Site #6038

Valencia, 46017

Spain

Ascentage Investigative Site #6041

Zaragoza, 50009

Spain

Ascentage Investigative Site #9216

Adapazarı, 54100

Turkey (Türkiye)

Ascentage Investigative Site #9218

Ankara, 06050

Turkey (Türkiye)

Ascentage Investigative Site #9204

Ankara, 06170

Turkey (Türkiye)

Ascentage Investigative Site #9215

Battalgazi, 44210

Turkey (Türkiye)

Ascentage Investigative Site #9217

Çankaya, 06800

Turkey (Türkiye)

Ascentage Investigative Site #9219

Istanbul, 34452

Turkey (Türkiye)

Ascentage Investigative Site #9205

Kepez, 07025

Turkey (Türkiye)

Ascentage Investigative Site #9208

Mezitli, 33200

Turkey (Türkiye)

Ascentage Investigative Site #9213

Ortahisar, 61080

Turkey (Türkiye)

Ascentage Investigative Site #9214

Samsun, 55270

Turkey (Türkiye)

Ascentage Investigative Site #9212

Yenimahalle, 06200

Turkey (Türkiye)

Ascentage Investigative Site #7017

Aberdeen, AB25 2ZN

United Kingdom

Ascentage Investigative Site #7036

Birmingham, B15 2GW

United Kingdom

Ascentage Investigative Site #7021

Boston, PE21 9QS

United Kingdom

Ascentage Investigative Site #7037

Bradford, BD9 6RJ

United Kingdom

Ascentage Investigative Site #7035

Liverpool, L7 8YA

United Kingdom

Ascentage Investigative Site #7016

London, SE5 9RS

United Kingdom

Ascentage Investigative Site #7015

London, W12 0HS

United Kingdom

Ascentage Investigative Site #7018

Newport, NP20 2UB

United Kingdom