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New targeted drug shows promise for Hard-to-Treat blood cancers

NCT ID NCT04771130

Disease control Sponsor: BeOne Medicines 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 4 times

Summary

This study is testing a new drug called BGB-11417 (sonrotoclax) in people with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or related blood cancers. The drug works by blocking a protein that helps cancer cells survive. The trial will give the drug alone or together with another drug called azacitidine. The main goals are to find the safest dose and see if the drug can shrink or control the cancer. About 260 people will take part in this early-phase study.

What this could mean

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

Active substance
BGB-11417 (sonrotoclax) and azacitidine
What this could lead to
If this trial succeeds, it could point toward a new treatment option for people with certain blood cancers like AML and MDS.
What could go wrong
This is an early-phase trial (phase 1/2) with a small number of participants, so the drug may not work as hoped or could cause unexpected side effects. The results will need confirmation in larger studies.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 260 people

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

Started

May 2021

Expected to finish

Aug 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.

Key Inclusion Criteria: 1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria: * AML, nonacute promyelocytic leukemia * MDS * MDS/MPN 2. Eastern Cooperative Oncology Group performance status of 0 to 2. 3. Adequate organ function defined as: * Creatinine clearance ≥ 50 milliliters/minute (mL/min) (or between 30 and 49 mL/min in unfit AML cohort) * Adequate liver function 4. Life expectancy of \> 12 weeks. 5. Ability to comply with the requirements of the study. Key Exclusion Criteria: 1. A diagnosis of acute promyelocytic leukemia. 2. History of prior malignancy, with the exception of either a history of MDS or MDS/MPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer) 3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation. 4. Prior therapy with a B-cell lymphoma-2 inhibitor 5. Known central nervous system involvement by leukemia. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome Myelodysplastic Syndromes myelodysplastic/myeloproliferative disease myelodysplastic/myeloproliferative neoplasm

As listed by the trial registrant

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

Acute myeloid leukemia Myelodysplastic syndromes Myelodysplastic/myeloproliferative neoplasm

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    42 sites in 9 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aotearoa Clinical Trials

    RECRUITING

    Auckland, 2025, New Zealand

  • Austin Health

    RECRUITING

    Heidelberg, Victoria, VIC 3084, Australia

  • City of Hope National Medical Center

    TERMINATED

    Duarte, California, 91010-3012, United States

  • Concord Repatriation General Hospital

    RECRUITING

    Concord, New South Wales, NSW 2139, Australia

  • Edinburgh Cancer Centre

    ACTIVE_NOT_RECRUITING

    Edinburgh, EH4 2XU, United Kingdom

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, Western Australia, WA 6150, Australia

  • Gold Coast University Hospital

    RECRUITING

    Southport, Queensland, QLD 4215, Australia

  • Guangdong Provincial Peoples Hospital

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Hopital Claude Huriez Chu Lille

    RECRUITING

    Lille, 59000, France

  • Hopital Larchet

    RECRUITING

    Nice, 06200, France

  • Hopital Saint Louis

    RECRUITING

    Paris, 75010, France

  • Hospital Universitari I Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Hospital de La Santa Creu I Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

    RECRUITING

    Meldola, 47014, Italy

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, WA 6009, Australia

  • Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-3907, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226-3522, United States

  • Monash Health

    RECRUITING

    Clayton, Victoria, VIC 3168, Australia

  • Nanfang Hospital, Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Niguarda Cancer Center Division of Hematology

    RECRUITING

    Milan, 20162, Italy

  • North Shore Hospital

    RECRUITING

    Auckland, 0622, New Zealand

  • One Clinical Research

    RECRUITING

    Nedlands, Western Australia, WA 6009, Australia

  • Orange Health Hospital

    RECRUITING

    Orange, New South Wales, NSW 2800, Australia

  • Peking University Peoples Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    RECRUITING

    Bologna, 40138, Italy

  • Samsung Medical Center

    RECRUITING

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • St George Hospital

    RECRUITING

    Kogarah, New South Wales, NSW 2217, Australia

  • St Vincents Hospital Melbourne

    RECRUITING

    Fitzroy, Victoria, VIC 3065, Australia

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606-3571, United States

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, VIC 3004, Australia

  • The Christie Hospital

    ACTIVE_NOT_RECRUITING

    Greater Manchester, M20 4BX, United Kingdom

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Lanzhou University

    RECRUITING

    Lanzhou, Gansu, 730000, China

  • The Second Peoples Hospital of Shenzhen

    COMPLETED

    Shenzhen, Guangdong, 518037, China

  • Tianjin Medical University Cancer Institute and Hospital

    COMPLETED

    Tianjin, Tianjin Municipality, 300060, China

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Universitaetsklinikum Leipzig Aor

    RECRUITING

    Leipzig, 04103, Germany

  • Universitaetsklinikum Ulm

    RECRUITING

    Ulm, 89081, Germany

  • Upmc Hillman Cancer Center(Univ of Pittsburgh)

    RECRUITING

    Pittsburgh, Pennsylvania, 15232-1309, United States

  • Wellington Regional Hospital (Ccdhb)

    RECRUITING

    Wellington, 6021, New Zealand

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

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Other studies related to the condition(s) this trial covers.