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AzTrials

Chronic Myeloid LeukemiaPhase 3POLARIS-2NCT06423911

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

A Phase 3 study testing olverembatinib and Bosutinib in people with Chronic Myeloid Leukemia and CML, run by Ascentage Pharma Group Inc. at 163 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myeloid Leukemia, CML, CML, Chronic Phase
What is being tested?
olverembatinib and Bosutinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
333 participants
Where
163 sitesin 16 countries
Study dates
5 Feb 2024to 10 Jul 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients eligible for inclusion in this study must meet all of the following criteria:
  • Age ≥ 18 years old
  • Diagnosis of CML-CP
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
  • Patient has adequate organ function

Who cannot join

  • Patients eligible for this study must not meet any of the following criteria:
  • For Part A only: T315I or V299L mutation at any time prior to starting study treatment
  • Active infection that requires systemic drug therapy
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
  • Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients
  • Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients
  • Pregnant or nursing (lactating) women

Trial locations and contacts

163 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

Ascentage Clinical Operations contact

301-291-5658

clinical-trials@ascentage.com

163 sites in 16 countries

United States50 sites, 50 recruiting

  • Ascentage Investigative Site #1072

    Albuquerque, New Mexico, 87102

    Recruiting

  • Ascentage Investigative Site #1051

    Amarillo, Texas, 79124

    Recruiting

  • Ascentage Investigative Site #1112

    Anchorage, Alaska, 99508

    Recruiting

  • Ascentage Investigative Site #1045

    Augusta, Georgia, 30912

    Recruiting

  • Ascentage Investigative Site #1036

    Austin, Texas, 78705

    Recruiting

  • Ascentage Investigative Site #1801

    Baltimore, Maryland, 21201

    Recruiting

  • Ascentage Investigative Site #1044

    Birmingham, Alabama, 35249

    Recruiting

  • Ascentage Investigative Site #1063

    Chattanooga, Tennessee, 37404

    Recruiting

  • Ascentage Investigative Site #1055

    Chicago, Illinois, 60637

    Recruiting

  • Ascentage Investigative Site #1173

    Cleveland, Ohio, 44111

    Not yet recruiting

  • Ascentage Investigative Site #1096

    Cleveland, Ohio, 44195

    Not yet recruiting

  • Ascentage Investigative Site #1095

    Decatur, Illinois, 62526

    Recruiting

  • Ascentage Investigative Site #1056

    Detroit, Michigan, 48201

    Recruiting

  • Ascentage Investigative Site #1023

    Detroit, Michigan, 49254

    Recruiting

  • Ascentage Investigative Site #1062

    Duarte, California, 91010

    Recruiting

  • Ascentage Investigative Site #1136

    Edmonds, Washington, 98026

    Recruiting

  • Ascentage Investigative Site #1111

    Goodyear, Arizona, 85338

    Recruiting

  • Ascentage Investigative Site #1019

    Greenville, North Carolina, 27858

    Not yet recruiting

  • Ascentage Investigative Site #1064

    Hackensack, New Jersey, 07601

    Recruiting

  • Ascentage Investigative Site #1501

    Houston, Texas, 77030

    Recruiting

  • Ascentage Investigative Site #1069

    Indianapolis, Indiana, 46237

    Recruiting

  • Ascentage Investigative Site #1099

    Irvine, California, 92618

    Recruiting

  • Ascentage Investigative Site #1135

    Issaquah, Washington, 98029

    Recruiting

  • Ascentage Investigative Site #1075

    La Jolla, California, 92037

    Recruiting

  • Ascentage Investigative Site #1066

    Las Vegas, Nevada, 89169

    Recruiting

  • Ascentage Investigative Site #1084

    Lexington, Kentucky, 40536

    Recruiting

  • Ascentage Investigative Site #1097

    Lincoln, Nebraska, 68506

    Not yet recruiting

  • Ascentage Investigative Site #1100

    Long Beach, California, 90813

    Recruiting

  • Ascentage Investigative Site #1059

    Los Angeles, California, 90024

    Recruiting

  • Ascentage Investigative Site #1058

    Louisville, Kentucky, 40202

    Recruiting

  • Ascentage Investigative Site #1174

    Mayfield Heights, Ohio, 44124

    Not yet recruiting

  • Ascentage Investigative Site #1054

    Morristown, New Jersey, 07960

    Recruiting

  • Ascentage Investigative Site #1043

    Morrisville, North Carolina, 27560

    Recruiting

  • Ascentage Investigative Site #1089

    Nashville, Tennessee, 37203

    Recruiting

  • Ascentage Investigative Site #1098

    New Brunswick, New Jersey, 08901

    Recruiting

  • Ascentage Investigative Site #1110

    Newnan, Georgia, 30265

    Recruiting

  • Ascentage Investigative Site #1057

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Ascentage Investigative Site #1022

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Ascentage Investigative Site #1139

    Portland, Oregon, 97239

    Not yet recruiting

  • Ascentage Investigative Site #1113

    Reno, Nevada, 89511

    Recruiting

  • Ascentage Investigative Site #1068

    Rochester, New York, 14642

    Recruiting

  • Ascentage Investigative Site #1121

    Sacramento, California, 95817

    Recruiting

  • Ascentage Investigative Site #1806

    Seattle, Washington, 98104

    Recruiting

  • Ascentage Investigative Site #1510

    Seattle, Washington, 98109

    Recruiting

  • Ascentage Investigative Site #1053

    Shirley, New York, 11967

    Recruiting

  • Ascentage Investigative Site #1088

    St Louis, Missouri, 63108

    Recruiting

  • Ascentage Investigative Site #1160

    Stony Brook, New York, 11794

    Not yet recruiting

  • Ascentage Investigative Site #1109

    Upland, California, 91786

    Recruiting

  • Ascentage Investigative Site #1050

    Virginia Beach, Virginia, 23456

    Recruiting

  • Ascentage Investigative Site #1065

    Wichita, Kansas, 67214

    Recruiting

Other trials in United States

Italy17 sites, 17 recruiting

  • Ascentage Investigative Site #5535

    Bologna, 40138

    Recruiting

  • Ascentage Investigative Site #5534

    Candiolo, 10060

    Recruiting

  • Ascentage Investigative Site #5527

    Catania, 95123

    Recruiting

  • Ascentage Investigative Site #5523

    Lecce, 73100

    Recruiting

  • Ascentage Investigative Site #5529

    Meldola, 47014

    Recruiting

  • Ascentage Investigative Site #5537

    Messina, 98124

    Not yet recruiting

  • Ascentage Investigative Site #5553

    Milan, 20122

    Recruiting

  • Ascentage Investigative Site #5530

    Naples, 80131

    Recruiting

  • Ascentage Investigative Site #5524

    Novara, 28100

    Recruiting

  • Ascentage Investigative Site #5525

    Padova, 35128

    Recruiting

  • Ascentage Investigative Site #5526

    Pisa, 56126

    Recruiting

  • Ascentage Investigative Site #5528

    Roma, 00144

    Recruiting

  • Ascentage Investigative Site #5522

    Roma, 00161

    Recruiting

  • Ascentage Investigative Site #5510

    Roma, 00168

    Not yet recruiting

  • Ascentage Investigative Site #5552

    Torino, 10126

    Not yet recruiting

  • Ascentage Investigative Site #5521

    Torino, 10128

    Recruiting

  • Ascentage Investigative Site #5536

    Varese, 21100

    Recruiting

Other trials in Italy

Spain16 sites, 16 recruiting

  • Ascentage Investigative Site #6015

    Badalona, 08916

    Recruiting

  • Ascentage Investigative Site #6020

    Barcelona, 08035

    Recruiting

  • Ascentage Investigative Site #6047

    Elche, 03293

    Recruiting

  • Ascentage Investigative Site #6014

    L'Hospitalet de Llobregat, 08906

    Recruiting

  • Ascentage Investigative Site #6035

    Madrid, 28006

    Recruiting

  • Ascentage Investigative Site #6013

    Madrid, 28007

    Recruiting

  • Ascentage Investigative Site #6033

    Madrid, 28031

    Recruiting

  • Ascentage Investigative Site #6011

    Madrid, 28041

    Recruiting

  • Ascentage Investigative Site #6032

    Madrid, 28046

    Recruiting

  • Ascentage Investigative Site #6037

    Majadahonda, 28222

    Recruiting

  • Ascentage Investigative Site #6012

    Málaga, 29010

    Recruiting

  • Ascentage Investigative Site #6039

    Málaga, 29010

    Recruiting

  • Ascentage Investigative Site #6051

    Murcia, 30120

    Not yet recruiting

  • Ascentage Investigative Site #6036

    Ourense, 32005

    Recruiting

  • Ascentage Investigative Site #6038

    Valencia, 46017

    Recruiting

  • Ascentage Investigative Site #6041

    Zaragoza, 50009

    Recruiting

Other trials in Spain

Japan12 sites, 12 recruiting

  • Ascentage Investigative Site #8101

    Ehime, 790-8524

    Recruiting

  • Ascentage Investigative Site #8102

    Kyoto, 602-8566

    Recruiting

  • Ascentage Investigative Site #8112

    Okayama, 701-1192

    Recruiting

  • Ascentage Investigative Site #8105

    Osaka, 565-0871

    Recruiting

  • Ascentage Investigative Site #8106

    Sapporo, 003-0006

    Recruiting

  • Ascentage Investigative Site #8107

    Sapporo, 060-8648

    Recruiting

  • Ascentage Investigative Site #8109

    Tochigi, 321-0207

    Recruiting

  • Ascentage Investigative Site #8114

    Tokyo, 113-8677

    Recruiting

  • Ascentage Investigative Site #8117

    Tokyo, 130-8575

    Recruiting

  • Ascentage Investigative Site #8110

    Tokyo, 141-8625

    Recruiting

  • Ascentage Investigative Site #8104

    Yamagata, 990-9585

    Recruiting

  • Ascentage Investigative Site #8103

    Yamanashi, 409-3898

    Recruiting

Other trials in Japan

Turkey (Türkiye)11 sites, 11 recruiting

  • Ascentage Investigative Site #9216

    Adapazarı, 54100

    Recruiting

  • Ascentage Investigative Site #9218

    Ankara, 06050

    Recruiting

  • Ascentage Investigative Site #9204

    Ankara, 06170

    Recruiting

  • Ascentage Investigative Site #9215

    Battalgazi, 44210

    Recruiting

  • Ascentage Investigative Site #9217

    Çankaya, 06800

    Not yet recruiting

  • Ascentage Investigative Site #9219

    Istanbul, 34452

    Not yet recruiting

  • Ascentage Investigative Site #9205

    Kepez, 07025

    Recruiting

  • Ascentage Investigative Site #9208

    Mezitli, 33200

    Recruiting

  • Ascentage Investigative Site #9213

    Ortahisar, 61080

    Recruiting

  • Ascentage Investigative Site #9214

    Samsun, 55270

    Recruiting

  • Ascentage Investigative Site #9212

    Yenimahalle, 06200

    Recruiting

Other trials in Turkey (Türkiye)

India10 sites

  • Ascentage Investigative Site #9118

    Bangalore, 560027

    Active, not recruiting

  • Ascentage Investigative Site #9120

    Haryāna, 122002

    Active, not recruiting

  • Ascentage Investigative Site #9102

    Haryāna, 124105

    Active, not recruiting

  • Ascentage Investigative Site #9110

    Hyderabad, 500033

    Active, not recruiting

  • Ascentage Investigative Site #9116

    Kolkata, 700014

    Active, not recruiting

  • Ascentage Investigative Site #9115

    Kolkata, 700054

    Active, not recruiting

  • Ascentage Investigative Site #9101

    New Delhi, 110029

    Active, not recruiting

  • Ascentage Investigative Site #9103

    New Delhi, 110076

    Active, not recruiting

  • Ascentage Investigative Site #9119

    Pune, 411001

    Active, not recruiting

  • Ascentage Investigative Site #9113

    Thiruvananthapuram, 695011

    Active, not recruiting

Other trials in India

Poland8 sites, 8 recruiting

  • Ascentage Investigative Site #4213

    Gdansk, 80214

    Recruiting

  • Ascentage Investigative Site #4212

    Gdansk, 80219

    Recruiting

  • Ascentage Investigative Site #4207

    Katowice, 40519

    Recruiting

  • Ascentage Investigative Site #4209

    Krakow, 30688

    Recruiting

  • Ascentage Investigative Site #4211

    Lodz, 93513

    Recruiting

  • Ascentage Investigative Site #4214

    Torun, 87100

    Recruiting

  • Ascentage Investigative Site #4210

    Wałbrzych, 58309

    Recruiting

  • Ascentage Investigative Site #4206

    Warsaw, 00791

    Not yet recruiting

Other trials in Poland

South Korea8 sites, 8 recruiting

  • Ascentage Investigative Site #8206

    Busan, 49201

    Recruiting

  • Ascentage Investigative Site #8207

    Busan, 49241

    Recruiting

  • Ascentage Investigative Site #8204

    Gyeonggi-do, 13620

    Recruiting

  • Ascentage Investigative Site #8201

    Seoul, 03080

    Recruiting

  • Ascentage Investigative Site #8202

    Seoul, 05505

    Recruiting

  • Ascentage Investigative Site #8205

    Seoul, 06351

    Recruiting

  • Ascentage Investigative Site #8203

    Seoul, 06591

    Recruiting

  • Ascentage Investigative Ste #8208

    Uijeongbu-si, 11749

    Recruiting

Other trials in South Korea

United Kingdom8 sites, 8 recruiting

  • Ascentage Investigative Site #7017

    Aberdeen, AB25 2ZN

    Recruiting

  • Ascentage Investigative Site #7036

    Birmingham, B15 2GW

    Recruiting

  • Ascentage Investigative Site #7021

    Boston, PE21 9QS

    Recruiting

  • Ascentage Investigative Site #7037

    Bradford, BD9 6RJ

    Recruiting

  • Ascentage Investigative Site #7035

    Liverpool, L7 8YA

    Recruiting

  • Ascentage Investigative Site #7016

    London, SE5 9RS

    Recruiting

  • Ascentage Investigative Site #7015

    London, W12 0HS

    Recruiting

  • Ascentage Investigative Site #7018

    Newport, NP20 2UB

    Recruiting

Other trials in United Kingdom

Belgium5 sites, 5 recruiting

  • Ascentage Investigative Site #5211

    Anderlecht, 1070

    Recruiting

  • Ascentage Investigative Site #5212

    Gilly, 6060

    Recruiting

  • Ascentage Investigative Site #5208

    Kortrijk, 8500

    Recruiting

  • Ascentage Investigative Site #5209

    Roeselare, 8800

    Recruiting

  • Ascentage Investigative Site #5210

    Yvoir, 5530

    Recruiting

Other trials in Belgium

France5 sites, 5 recruiting

  • Ascentage Investigative Site #5037

    Amiens, 80054

    Recruiting

  • Ascentage Investigative Site #5015

    Bobigny, 93000

    Recruiting

  • Ascentage Investigative Site #5017

    Nice, 06202

    Recruiting

  • Ascentage Investigative Site #5016

    Rouen, 76038

    Recruiting

  • Ascentage Investigative Site #5023

    Toulouse, 31059

    Recruiting

Other trials in France

Australia4 sites, 4 recruiting

  • Ascentage Investigative Site #2115

    Adelaide, South Australia, 5000

    Recruiting

  • Ascentage Investigative Site #2107

    Campbelltown, New South Wales, 2560

    Recruiting

  • Ascentage Investigative Site #2105

    Liverpool, New South Wales, 2170

    Recruiting

  • Ascentage Investigative Site #2106

    Perth, Western Australia, 6000

    Recruiting

Other trials in Australia

Russia4 sites

  • Ascentage Investigative Site #3227

    Moscow, 125167

    Active, not recruiting

  • Ascentage Investigative Site #3228

    Saint Petersburg, 191024

    Active, not recruiting

  • Ascentage Investigative Site #3213

    Saint Petersburg, 194291

    Active, not recruiting

  • Ascentage Investigative Site #3212

    Saint Petersburg, 197341

    Active, not recruiting

Other trials in Russia

Germany2 sites, 2 recruiting

  • Ascentage Investigative Site #5708

    Berlin, 13353

    Recruiting

  • Ascentage Investigative Site #5709

    Dresden, 01307

    Recruiting

Other trials in Germany

Singapore2 sites, 2 recruiting

  • Ascentage Investigative Site #6602

    Singapore, 117599

    Recruiting

  • Ascentage Investigative Site #6601

    Singapore, 168583

    Recruiting

Other trials in Singapore

Canada1 site, 1 recruiting

  • Ascentage Investigative Site #8004

    Toronto, M5G 2M9

    Recruiting

Other trials in Canada

About this study

Official title: A Global, Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP)

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.

Being tested
olverembatinib, Bosutinib
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • olverembatinibDrug

    olverembatinib QOD

  • BosutinibDrug

    Bosutnib QD

Study groups in NCT06423911
Study groupRoleWhat they receive
Part A, RCT, olverembatinib arm and bosutinib armOtherRandomized 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
Receives: Drug: olverembatinib; Drug: Bosutinib
Part B, SAT, olverembatinib armOtherTo evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously
Receives: Drug: olverembatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24-Week MMR Rate (Part A)

    To compare the major molecular response (MMR) rate at 24 weeks for olverembatinib versus bosutinib

    Measured: 24 weeks

  2. 24-Week MMR Rate (Part B)

    To evaluate the MMR rate by 24 weeks for olverembatinib in CML-CP patients with T315I mutation

    Measured: 24 weeks

Secondary outcomes (10)

  1. 96-Week MMR Rate (Part A)

    To compare the major molecular response (MMR) rate at 96 weeks for olverembatinib versus bosutinib

    Measured: 96 weeks

  2. 96-Week MMR Rate (Part B)

    To evaluate the major molecular response (MMR) rate by 96 weeks for olverembatinib in CML-CP patients with T315I mutation

    Measured: 96 weeks

  3. Cytogenic Response Rate (Part A)

    To compare the complete cytogenic response rate at all scheduled data collection time points for olverembatinib vs. bosutinib.

    Measured: Through 96 weeks (i.e., at 24, 48, and 96 weeks)

  4. Cytogenic Response Rate (Part B)

    To evaluate the complete cytogenic response rate at all scheduled data collection time points for olverembatinib in CML-CP patients with T315I mutation

    Measured: Through 96 weeks (i.e., at 24, 48, and 96 weeks)

  5. Progression Free Survival (PFS) (Part A)

    To compare duration of PFS (i.e., from the date of randomization to the earliest occurrence of documented disease progression to AP/BP or the date of death from any cause) for olverembatinib versus bosutinib

    Measured: 5 years after the last patient received the first study dose

  6. Progression Free Survival (PFS) (Part B)

    To evaluate duration of PFS (i.e., from the date of enrollment to the earliest occurrence of documented disease progression to AP/BP or the date of death from any cause) for olverembatinib in CML-CP patients with T315I mutation

    Measured: 5 years after the last patient received the first study dose

  7. Overall Survival (OS) (Part A)

    To compare OS (duration from date of randomization to date of death) for olverembatinib versus bosutinib

    Measured: 5 years after the last patient received the first study dose

  8. Overall Survival (OS) (Part B)

    To evaluate OS (duration from date of randomization to date of death) for olverembatinib in CML-CP patients with T315I mutation

    Measured: 5 years after the last patient received the first study dose

  9. Number of participants with treatment-emergent and treatment-related adverse events as assessed by CTCAE v5.0 (Parts A and B)

    According to CTCAE v5.0, the number and frequency of adverse events for test drug will be assessed.

    Measured: 96 weeks after the last patient received the first study dose

  10. Characterization of population pharmacokinetics of olverembatinib (Parts A and B)

    Blood samples will be collected to measure the plasma concentration of olverembatinib

    Measured: At the end of Cycle 1 and Cycle 2 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2024
  2. Study start5 Feb 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion10 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part A (285 patients): Randomization to olverembatinib or bosutinib at 2:1 ratio. Part B in patients with T315I mutation (48 patients): Single-arm part; all enrolled patients receive olverembatinib.
Masking
None (open label)
Enrolment
333 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06423911
Sponsor's protocol ID
HQP1351CG301
Acronym
POLARIS-2
Status last verified
Sep 2026
First submitted
16 May 2024
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing olverembatinib and Bosutinib in people with Chronic Myeloid Leukemia and CML, run by Ascentage Pharma Group Inc. at 163 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 163 sites in United States, Italy, Spain, Japan, Turkey (Türkiye) and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ascentage Clinical Operations (301-291-5658, clinical-trials@ascentage.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-Week MMR Rate (Part A) (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06423911.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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