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New drug takes aim at Treatment-Resistant leukemia

NCT ID NCT06423911

Disease control Sponsor: Ascentage Pharma Group Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are comparing olverembatinib, an experimental drug, with bosutinib, an approved drug, in adults with chronic phase chronic myeloid leukemia (CML-CP). The trial enrolls patients whose disease has not responded well to at least two prior targeted treatments. A separate part of the study tests olverembatinib alone in patients whose leukemia carries the T315I mutation, which makes many standard drugs stop working. The main goal is to see how many patients achieve a major molecular response, meaning the amount of leukemia in the body drops to very low levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
olverembatinib, an experimental targeted leukemia drug, compared with bosutinib
What this could lead to
If olverembatinib works better than bosutinib, it could give people with hard-to-treat chronic myeloid leukemia another option, including those with the T315I mutation.
What could go wrong
This is a phase 3 trial, so the drug's benefit and safety are still being tested. Olverembatinib may not outperform bosutinib, and it can cause side effects that make it hard for some patients to continue.
Why investors are watching

Ascentage Pharma runs this phase 3 trial to test olverembatinib against bosutinib in chronic phase chronic myeloid leukemia, with a second part testing the drug in patients whose disease carries the T315I mutation. For a small company, a registrational trial like this can decide whether the drug reaches approval and whether the company has a commercial product.

If it works: A positive result may support regulatory approval and give Ascentage a drug it can sell, which would matter a great deal for a company of its size.

If it fails: If the trial fails or faces delays, the company may lose a key path to approval and the time and money already spent. Most cancer trials do not succeed.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 333 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic myeloid leukemia CML CML, chronic phase

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    149 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ascentage Investigative Site #1019

    NOT_YET_RECRUITING

    Greenville, North Carolina, 27858, United States

  • Ascentage Investigative Site #1022

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Ascentage Investigative Site #1023

    RECRUITING

    Detroit, Michigan, 49254, United States

  • Ascentage Investigative Site #1036

    RECRUITING

    Austin, Texas, 78705, United States

  • Ascentage Investigative Site #1043

    RECRUITING

    Morrisville, North Carolina, 27560, United States

  • Ascentage Investigative Site #1044

    RECRUITING

    Birmingham, Alabama, 35249, United States

  • Ascentage Investigative Site #1045

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Ascentage Investigative Site #1050

    RECRUITING

    Virginia Beach, Virginia, 23456, United States

  • Ascentage Investigative Site #1051

    RECRUITING

    Amarillo, Texas, 79124, United States

  • Ascentage Investigative Site #1053

    RECRUITING

    Shirley, New York, 11967, United States

  • Ascentage Investigative Site #1054

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Ascentage Investigative Site #1055

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Ascentage Investigative Site #1056

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Ascentage Investigative Site #1057

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Ascentage Investigative Site #1058

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Ascentage Investigative Site #1059

    RECRUITING

    Los Angeles, California, 90024, United States

  • Ascentage Investigative Site #1062

    RECRUITING

    Duarte, California, 91010, United States

  • Ascentage Investigative Site #1063

    RECRUITING

    Chattanooga, Tennessee, 37404, United States

  • Ascentage Investigative Site #1064

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Ascentage Investigative Site #1065

    RECRUITING

    Wichita, Kansas, 67214, United States

  • Ascentage Investigative Site #1066

    RECRUITING

    Las Vegas, Nevada, 89169, United States

  • Ascentage Investigative Site #1068

    RECRUITING

    Rochester, New York, 14642, United States

  • Ascentage Investigative Site #1069

    RECRUITING

    Indianapolis, Indiana, 46237, United States

  • Ascentage Investigative Site #1072

    RECRUITING

    Albuquerque, New Mexico, 87102, United States

  • Ascentage Investigative Site #1075

    RECRUITING

    La Jolla, California, 92037, United States

  • Ascentage Investigative Site #1084

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • Ascentage Investigative Site #1088

    RECRUITING

    St Louis, Missouri, 63108, United States

  • Ascentage Investigative Site #1089

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Ascentage Investigative Site #1095

    RECRUITING

    Decatur, Illinois, 62526, United States

  • Ascentage Investigative Site #1096

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Ascentage Investigative Site #1097

    NOT_YET_RECRUITING

    Lincoln, Nebraska, 68506, United States

  • Ascentage Investigative Site #1098

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Ascentage Investigative Site #1099

    RECRUITING

    Irvine, California, 92618, United States

  • Ascentage Investigative Site #1100

    RECRUITING

    Long Beach, California, 90813, United States

  • Ascentage Investigative Site #1109

    RECRUITING

    Upland, California, 91786, United States

  • Ascentage Investigative Site #1110

    RECRUITING

    Newnan, Georgia, 30265, United States

  • Ascentage Investigative Site #1111

    RECRUITING

    Goodyear, Arizona, 85338, United States

  • Ascentage Investigative Site #1112

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Ascentage Investigative Site #1113

    RECRUITING

    Reno, Nevada, 89511, United States

  • Ascentage Investigative Site #1121

    RECRUITING

    Sacramento, California, 95817, United States

  • Ascentage Investigative Site #1135

    RECRUITING

    Issaquah, Washington, 98029, United States

  • Ascentage Investigative Site #1136

    RECRUITING

    Edmonds, Washington, 98026, United States

  • Ascentage Investigative Site #1139

    NOT_YET_RECRUITING

    Portland, Oregon, 97239, United States

  • Ascentage Investigative Site #1160

    NOT_YET_RECRUITING

    Stony Brook, New York, 11794, United States

  • Ascentage Investigative Site #1173

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44111, United States

  • Ascentage Investigative Site #1174

    NOT_YET_RECRUITING

    Mayfield Heights, Ohio, 44124, United States

  • Ascentage Investigative Site #1501

    RECRUITING

    Houston, Texas, 77030, United States

  • Ascentage Investigative Site #1510

    RECRUITING

    Seattle, Washington, 98109, United States

  • Ascentage Investigative Site #1801

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Ascentage Investigative Site #1806

    RECRUITING

    Seattle, Washington, 98104, United States

  • Ascentage Investigative Site #2105

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • Ascentage Investigative Site #2106

    RECRUITING

    Perth, Western Australia, 6000, Australia

  • Ascentage Investigative Site #2107

    RECRUITING

    Campbelltown, New South Wales, 2560, Australia

  • Ascentage Investigative Site #2115

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Ascentage Investigative Site #3212

    ACTIVE_NOT_RECRUITING

    Saint Petersburg, 197341, Russia

  • Ascentage Investigative Site #3213

    ACTIVE_NOT_RECRUITING

    Saint Petersburg, 194291, Russia

  • Ascentage Investigative Site #3227

    ACTIVE_NOT_RECRUITING

    Moscow, 125167, Russia

  • Ascentage Investigative Site #3228

    ACTIVE_NOT_RECRUITING

    Saint Petersburg, 191024, Russia

  • Ascentage Investigative Site #4206

    NOT_YET_RECRUITING

    Warsaw, 00791, Poland

  • Ascentage Investigative Site #4207

    RECRUITING

    Katowice, 40519, Poland

  • Ascentage Investigative Site #4209

    RECRUITING

    Krakow, 30688, Poland

  • Ascentage Investigative Site #4210

    RECRUITING

    Wałbrzych, 58309, Poland

  • Ascentage Investigative Site #4211

    RECRUITING

    Lodz, 93513, Poland

  • Ascentage Investigative Site #4212

    RECRUITING

    Gdansk, 80219, Poland

  • Ascentage Investigative Site #4213

    RECRUITING

    Gdansk, 80214, Poland

  • Ascentage Investigative Site #4214

    RECRUITING

    Torun, 87100, Poland

  • Ascentage Investigative Site #5015

    RECRUITING

    Bobigny, 93000, France

  • Ascentage Investigative Site #5016

    RECRUITING

    Rouen, 76038, France

  • Ascentage Investigative Site #5017

    RECRUITING

    Nice, 06202, France

  • Ascentage Investigative Site #5023

    RECRUITING

    Toulouse, 31059, France

  • Ascentage Investigative Site #5037

    RECRUITING

    Amiens, 80054, France

  • Ascentage Investigative Site #5208

    RECRUITING

    Kortrijk, 8500, Belgium

  • Ascentage Investigative Site #5209

    RECRUITING

    Roeselare, 8800, Belgium

  • Ascentage Investigative Site #5210

    RECRUITING

    Yvoir, 5530, Belgium

  • Ascentage Investigative Site #5211

    RECRUITING

    Anderlecht, 1070, Belgium

  • Ascentage Investigative Site #5212

    RECRUITING

    Gilly, 6060, Belgium

  • Ascentage Investigative Site #5510

    NOT_YET_RECRUITING

    Roma, 00168, Italy

  • Ascentage Investigative Site #5521

    RECRUITING

    Torino, 10128, Italy

  • Ascentage Investigative Site #5522

    RECRUITING

    Roma, 00161, Italy

  • Ascentage Investigative Site #5523

    RECRUITING

    Lecce, 73100, Italy

  • Ascentage Investigative Site #5524

    RECRUITING

    Novara, 28100, Italy

  • Ascentage Investigative Site #5525

    RECRUITING

    Padova, 35128, Italy

  • Ascentage Investigative Site #5526

    RECRUITING

    Pisa, 56126, Italy

  • Ascentage Investigative Site #5527

    RECRUITING

    Catania, 95123, Italy

  • Ascentage Investigative Site #5528

    RECRUITING

    Roma, 00144, Italy

  • Ascentage Investigative Site #5529

    RECRUITING

    Meldola, 47014, Italy

  • Ascentage Investigative Site #5530

    RECRUITING

    Naples, 80131, Italy

  • Ascentage Investigative Site #5534

    RECRUITING

    Candiolo, 10060, Italy

  • Ascentage Investigative Site #5535

    RECRUITING

    Bologna, 40138, Italy

  • Ascentage Investigative Site #5536

    RECRUITING

    Varese, 21100, Italy

  • Ascentage Investigative Site #5537

    NOT_YET_RECRUITING

    Messina, 98124, Italy

  • Ascentage Investigative Site #5552

    NOT_YET_RECRUITING

    Torino, 10126, Italy

  • Ascentage Investigative Site #5553

    RECRUITING

    Milan, 20122, Italy

  • Ascentage Investigative Site #5708

    RECRUITING

    Berlin, 13353, Germany

  • Ascentage Investigative Site #5709

    RECRUITING

    Dresden, 01307, Germany

  • Ascentage Investigative Site #6011

    RECRUITING

    Madrid, 28041, Spain

  • Ascentage Investigative Site #6012

    RECRUITING

    Málaga, 29010, Spain

  • Ascentage Investigative Site #6013

    RECRUITING

    Madrid, 28007, Spain

  • Ascentage Investigative Site #6014

    RECRUITING

    L'Hospitalet de Llobregat, 08906, Spain

  • Ascentage Investigative Site #6015

    RECRUITING

    Badalona, 08916, Spain

  • Ascentage Investigative Site #6020

    RECRUITING

    Barcelona, 08035, Spain

  • Ascentage Investigative Site #6032

    RECRUITING

    Madrid, 28046, Spain

  • Ascentage Investigative Site #6033

    RECRUITING

    Madrid, 28031, Spain

  • Ascentage Investigative Site #6035

    RECRUITING

    Madrid, 28006, Spain

  • Ascentage Investigative Site #6036

    RECRUITING

    Ourense, 32005, Spain

  • Ascentage Investigative Site #6037

    RECRUITING

    Majadahonda, 28222, Spain

  • Ascentage Investigative Site #6038

    RECRUITING

    Valencia, 46017, Spain

  • Ascentage Investigative Site #6039

    RECRUITING

    Málaga, 29010, Spain

  • Ascentage Investigative Site #6041

    RECRUITING

    Zaragoza, 50009, Spain

  • Ascentage Investigative Site #6047

    RECRUITING

    Elche, 03293, Spain

  • Ascentage Investigative Site #6051

    NOT_YET_RECRUITING

    Murcia, 30120, Spain

  • Ascentage Investigative Site #6601

    RECRUITING

    Singapore, 168583, Singapore

  • Ascentage Investigative Site #6602

    RECRUITING

    Singapore, 117599, Singapore

  • Ascentage Investigative Site #7015

    RECRUITING

    London, W12 0HS, United Kingdom

  • Ascentage Investigative Site #7016

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Ascentage Investigative Site #7017

    RECRUITING

    Aberdeen, AB25 2ZN, United Kingdom

  • Ascentage Investigative Site #7018

    RECRUITING

    Newport, NP20 2UB, United Kingdom

  • Ascentage Investigative Site #7021

    RECRUITING

    Boston, PE21 9QS, United Kingdom

  • Ascentage Investigative Site #7035

    RECRUITING

    Liverpool, L7 8YA, United Kingdom

  • Ascentage Investigative Site #7036

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • Ascentage Investigative Site #7037

    RECRUITING

    Bradford, BD9 6RJ, United Kingdom

  • Ascentage Investigative Site #8004

    RECRUITING

    Toronto, M5G 2M9, Canada

  • Ascentage Investigative Site #8101

    RECRUITING

    Ehime, 790-8524, Japan

  • Ascentage Investigative Site #8102

    RECRUITING

    Kyoto, 602-8566, Japan

  • Ascentage Investigative Site #8103

    RECRUITING

    Yamanashi, 409-3898, Japan

  • Ascentage Investigative Site #8104

    RECRUITING

    Yamagata, 990-9585, Japan

  • Ascentage Investigative Site #8105

    RECRUITING

    Osaka, 565-0871, Japan

  • Ascentage Investigative Site #8106

    RECRUITING

    Sapporo, 003-0006, Japan

  • Ascentage Investigative Site #8107

    RECRUITING

    Sapporo, 060-8648, Japan

  • Ascentage Investigative Site #8109

    RECRUITING

    Tochigi, 321-0207, Japan

  • Ascentage Investigative Site #8110

    RECRUITING

    Tokyo, 141-8625, Japan

  • Ascentage Investigative Site #8112

    RECRUITING

    Okayama, 701-1192, Japan

  • Ascentage Investigative Site #8114

    RECRUITING

    Tokyo, 113-8677, Japan

  • Ascentage Investigative Site #8117

    RECRUITING

    Tokyo, 130-8575, Japan

  • Ascentage Investigative Site #8201

    RECRUITING

    Seoul, 03080, South Korea

  • Ascentage Investigative Site #8202

    RECRUITING

    Seoul, 05505, South Korea

  • Ascentage Investigative Site #8203

    RECRUITING

    Seoul, 06591, South Korea

  • Ascentage Investigative Site #8204

    RECRUITING

    Gyeonggi-do, 13620, South Korea

  • Ascentage Investigative Site #8205

    RECRUITING

    Seoul, 06351, South Korea

  • Ascentage Investigative Site #8206

    RECRUITING

    Busan, 49201, South Korea

  • Ascentage Investigative Site #8207

    RECRUITING

    Busan, 49241, South Korea

  • Ascentage Investigative Site #9101

    ACTIVE_NOT_RECRUITING

    New Delhi, 110029, India

  • Ascentage Investigative Site #9102

    ACTIVE_NOT_RECRUITING

    Haryāna, 124105, India

  • Ascentage Investigative Site #9103

    ACTIVE_NOT_RECRUITING

    New Delhi, 110076, India

  • Ascentage Investigative Site #9110

    ACTIVE_NOT_RECRUITING

    Hyderabad, 500033, India

  • Ascentage Investigative Site #9113

    ACTIVE_NOT_RECRUITING

    Thiruvananthapuram, 695011, India

  • Ascentage Investigative Site #9115

    ACTIVE_NOT_RECRUITING

    Kolkata, 700054, India

  • Ascentage Investigative Site #9116

    ACTIVE_NOT_RECRUITING

    Kolkata, 700014, India

  • Ascentage Investigative Site #9118

    ACTIVE_NOT_RECRUITING

    Bangalore, 560027, India

  • Ascentage Investigative Site #9119

    ACTIVE_NOT_RECRUITING

    Pune, 411001, India

  • Ascentage Investigative Site #9120

    ACTIVE_NOT_RECRUITING

    Haryāna, 122002, India

  • Ascentage Investigative Site #9204

    RECRUITING

    Ankara, 06170, Turkey (Türkiye)

  • Ascentage Investigative Site #9205

    RECRUITING

    Kepez, 07025, Turkey (Türkiye)

  • Ascentage Investigative Site #9208

    RECRUITING

    Mezitli, 33200, Turkey (Türkiye)

  • Ascentage Investigative Site #9212

    RECRUITING

    Yenimahalle, 06200, Turkey (Türkiye)

  • Ascentage Investigative Site #9213

    RECRUITING

    Ortahisar, 61080, Turkey (Türkiye)

  • Ascentage Investigative Site #9214

    RECRUITING

    Samsun, 55270, Turkey (Türkiye)

  • Ascentage Investigative Site #9215

    RECRUITING

    Battalgazi, 44210, Turkey (Türkiye)

  • Ascentage Investigative Site #9216

    RECRUITING

    Adapazarı, 54100, Turkey (Türkiye)

  • Ascentage Investigative Site #9217

    NOT_YET_RECRUITING

    Çankaya, 06800, Turkey (Türkiye)

  • Ascentage Investigative Site #9218

    RECRUITING

    Ankara, 06050, Turkey (Türkiye)

  • Ascentage Investigative Site #9219

    NOT_YET_RECRUITING

    Istanbul, 34452, Turkey (Türkiye)

  • Ascentage Investigative Ste #8208

    RECRUITING

    Uijeongbu-si, 11749, South Korea

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