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New drug aims to wipe out cancer protein in Tough-to-Treat blood cancers

NCT ID NCT05006716

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 11, 2026 · Updated 9 times

Summary

This study tests a new oral drug, BGB-16673, designed to destroy a protein called BTK that helps certain blood cancers grow. The trial includes about 645 people with various B-cell cancers (like lymphoma and leukemia) that have come back or not responded to prior treatments. The goal is to find the safest dose and see if the drug can shrink tumors.

What this could mean

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

Active substance
BGB-16673 (a drug that destroys a protein called BTK, which helps some blood cancers grow)
What this could lead to
If it works, this could offer a new treatment option for people with B-cell cancers that have stopped responding to other therapies.
What could go wrong
This is an early-phase trial (Phase 1/2), so the drug may not work or could cause serious side effects. It is also only for people whose cancer has returned or not responded to prior treatments.

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 645 people

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

Started

Sep 2021

Expected to finish

Nov 2029

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 : 1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R/R follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), R/R diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL. 2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance). 3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance. 4. Phase 2 Cohorts in R/R CLL/SLL, R/R MCL, and R/R WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression. 5. Measurable disease by radiographic assessment or serum IgM level (WM only) 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 7. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL/SLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2). Exclusion Criteria: 1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur. 2. Requires ongoing systemic treatment for any other malignancy 3. Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment. 4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease 5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia B-cell neoplasm diffuse large B-cell lymphoma follicular lymphoma Lymphoma, B-Cell, Marginal Zone mantle cell lymphoma marginal zone lymphoma non-Hodgkin lymphoma relapsed/refractory diffuse large B-cell lymphoma Richter transformation Waldenstrom macroglobulinemia

As listed by the trial registrant

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

B-cell malignancy Chronic lymphocytic leukemia Diffuse large B-cell lymphoma Follicular lymphoma Mantle cell lymphoma Marginal zone lymphoma Non-Hodgkin lymphoma Small lymphocytic lymphoma Waldenström macroglobulinemia

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

    105 sites in 15 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

  • Aichi Cancer Center Hospital Clinical Oncology

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • American Oncology Partners of Maryland Pa

    RECRUITING

    Bethesda, Maryland, 20817-7847, United States

  • Arensia Exploratory Medicine Llc

    RECRUITING

    Tbilisi, 0119, Georgia

  • Arthur Je Child Comprehensive Cancer Centre

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

  • Asan Medical Center

    RECRUITING

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Augusta University

    RECRUITING

    Augusta, Georgia, 30912-0002, United States

  • Austin Health

    RECRUITING

    Heidelberg, Victoria, VIC 3084, Australia

  • British Columbia Cancer Agency the Vancouver Centre

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Calvary Mater Newcastle

    RECRUITING

    Waratah, New South Wales, NSW 2298, Australia

  • Cancer Institute Hospital of Jfcr

    RECRUITING

    Kotoku, Tokyo, 135-8550, Japan

  • Centre Henri Becquerel

    RECRUITING

    Rouen, 76038, France

  • Centre Leon Berard

    RECRUITING

    Lyon, 69373, France

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    RECRUITING

    Bordeaux, 33076, France

  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

    RECRUITING

    Porto Alegre, 90110-270, Brazil

  • Centroricerche Cliniche Di Verona Srl

    RECRUITING

    Verona, 37134, Italy

  • Chiba Cancer Center

    RECRUITING

    Chiba, Chiba, 260-8717, Japan

  • Chu Henri Mondor

    RECRUITING

    Créteil, 94000, France

  • Chu Montpellier Hopital Saint Eloi

    RECRUITING

    Montpellier, 34090, France

  • Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)

    RECRUITING

    Québec, Quebec, G1J 1Z4, Canada

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Comprehensive Cancer Centers of Nevada

    RECRUITING

    Las Vegas, Nevada, 89169-3321, United States

  • Concord Repatriation General Hospital

    RECRUITING

    Concord, New South Wales, NSW 2139, Australia

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215-5418, United States

  • Derriford Hospital

    RECRUITING

    Plymouth, PL6 8DH, United Kingdom

  • Dokuz Eylul University

    RECRUITING

    Balçova, 35330, Turkey (Türkiye)

  • Edinburgh Cancer Centre

    RECRUITING

    Edinburgh, EH4 2XU, United Kingdom

  • Erciyes University

    RECRUITING

    Kayseri, 38030, Turkey (Türkiye)

  • Fondazione Policlinico Universitario Agostino Gemelli

    RECRUITING

    Roma, 00168, Italy

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109-4433, United States

  • Freeman Hospital

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Genesiscare Cambridge

    RECRUITING

    Newmarket, CB8 7XN, United Kingdom

  • Henan Cancer Hospital

    ACTIVE_NOT_RECRUITING

    Zhengzhou, Henan, 450000, China

  • Honor Health Research Institute

    RECRUITING

    Scottsdale, Arizona, 85258-4566, United States

  • Hopital Claude Huriez Chu Lille

    RECRUITING

    Lille, 59000, France

  • Hopital Estaing

    RECRUITING

    ClermontFerrand, 63100, France

  • Hopital de La Pitie Salpetriere

    RECRUITING

    Paris, 75013, France

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Erasto Gaertner

    RECRUITING

    Curitiba, 81520-060, Brazil

  • Hospital General Universitario Gregorio Maranon

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Nove de Julho Dasa

    RECRUITING

    São Paulo, 01409-001, Brazil

  • Hospital Sirio Libanes Brasilia

    RECRUITING

    Brasília, 70200-730, Brazil

  • Hospital Universitario Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    RECRUITING

    Majadahonda, 28222, Spain

  • Hospital Universitario Vall Dhebron

    RECRUITING

    Barcelona, 08035, Spain

  • Inje University Busan Paik Hospital

    RECRUITING

    BusanjinGu, Busan Gwang'Yeogsi, 47392, South Korea

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, 13009, France

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch

    ACTIVE_NOT_RECRUITING

    Tianjin, Tianjin Municipality, 301617, China

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    RECRUITING

    São Paulo, 01401-004, Brazil

  • Istituto Europeo Di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201-2013, United States

  • Karolinska Universitetssjukhuset Solna

    RECRUITING

    Stockholm, 171 76, Sweden

  • Klinikum Grosshadern Ludwig Maximilians Universitat Munchen

    RECRUITING

    München, 81377, Germany

  • Klinikum Johannes Gutenberg Universitaet Mainz

    RECRUITING

    Mainz, 55131, Germany

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, WA 6009, Australia

  • Mary Bird Perkins Cancer Center

    RECRUITING

    Baton Rouge, Louisiana, 70809-3738, United States

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224-1865, United States

  • Mayo Clinic Phoenix

    COMPLETED

    Phoenix, Arizona, 85054-4502, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905-0001, United States

  • Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-3907, United States

  • Md Anderson Cancer Center Madrid Spain

    RECRUITING

    Madrid, 28033, Spain

  • Memorial Sloan Kettering Cancer Center Mskcc

    RECRUITING

    New York, New York, 10065-6800, United States

  • Midwestern Regional Medical Center

    COMPLETED

    Zion, Illinois, 60099-2676, United States

  • Mount Sinai Medical Center Braman Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33140, United States

  • Nanfang Hospital, Southern Medical University

    ACTIVE_NOT_RECRUITING

    Guangzhou, Guangdong, 510515, China

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Niguarda Cancer Center Division of Hematology

    RECRUITING

    Milan, 20162, Italy

  • Norfolk and Norwich University Hospitals Nhs Foundation Trust

    RECRUITING

    Norwich, NR4 7UY, United Kingdom

  • Norton Cancer Institute Pavilion

    ACTIVE_NOT_RECRUITING

    Louisville, Kentucky, 40207-4700, United States

  • Nottingham University Hospitals Nhs Trust

    RECRUITING

    Nottingham, NG5 1PB, United Kingdom

  • Ondokuz Mayis University

    RECRUITING

    Samsun, 55200, Turkey (Türkiye)

  • Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Peking Union Medical College Hospital

    ACTIVE_NOT_RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Perth Blood Institute

    RECRUITING

    West Perth, Western Australia, WA 6005, Australia

  • Peter Maccallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, VIC 3000, Australia

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    RECRUITING

    Bologna, 40138, Italy

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, QLD 4102, Australia

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Pusan National University Hospital

    RECRUITING

    Seogu, Busan Gwang'Yeogsi, 49241, South Korea

  • Real E Benemerita Associacao Portuguesa de Sao Paulo

    RECRUITING

    São Paulo, 01321-001, Brazil

  • Roswell Park Comprehensive Cancer Center

    RECRUITING

    Buffalo, New York, 14203, United States

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    ACTIVE_NOT_RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

  • Sahlgrenska University Hospital Hematology

    RECRUITING

    Gothenburg, 413 46, Sweden

  • Sakarya Training and Research Hospital

    RECRUITING

    Sakarya, 54100, Turkey (Türkiye)

  • Samsung Medical Center

    RECRUITING

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    RECRUITING

    São Paulo, 05652-900, Brazil

  • Southeastern Regional Medical Center

    RECRUITING

    Newnan, Georgia, 30265-8001, United States

  • St Jamess University Hospital

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • St Vincents Hospital Melbourne

    RECRUITING

    Fitzroy, Victoria, VIC 3065, Australia

  • Stanford Medicine

    RECRUITING

    Palo Alto, California, 94304-2205, United States

  • Tampa General Hospital Cancer Institute

    RECRUITING

    Tampa, Florida, 33606-3571, United States

  • Tennesse Oncology Chattanooga Downtown

    RECRUITING

    Chattanooga, Tennessee, 37404, United States

  • Tennessee Oncology, Pllc Nashville

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, VIC 3004, Australia

  • The Catholic University of Korea, Seoul St Marys Hospital

    RECRUITING

    SeochoGu, Seoul Teugbyeolsi, 06591, South Korea

  • The First Affiliated Hospital of Wenzhou Medical University

    ACTIVE_NOT_RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The Institute of Oncology, Arensia Exploratory Medicine

    RECRUITING

    Chisinau, 2025, Moldova

  • UCLA Santa Monica Cancer Care

    RECRUITING

    Santa Monica, California, 90404-2023, United States

  • Uchealth North

    RECRUITING

    Fort Collins, Colorado, 80528-3413, United States

  • Uniklinik Koeln (Aoer)

    RECRUITING

    Cologne, 50937, Germany

  • Universitaetsklinikum Schleswig Holstein Campus Luebeck

    RECRUITING

    Lübeck, 23538, Germany

  • Universitaetsklinikum Ulm

    RECRUITING

    Ulm, 89081, Germany

  • Universitares Krebszentrum Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

    RECRUITING

    Dresden, 01307, Germany

  • University of Alabama At Birmingham Hospital

    RECRUITING

    Birmingham, Alabama, 35294-0004, United States

  • University of Arizona Cancer Center

    RECRUITING

    Tucson, Arizona, 85724-0001, United States

  • University of California San Diego (Ucsd) Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093-1503, United States

  • University of Iowa Hospitals and Clinics

    RECRUITING

    Iowa City, Iowa, 52242-1009, United States

  • Virginia Commonwealth University Massey Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Weill Cornell Medical College Newyork Presbyterian Hospital

    RECRUITING

    New York, New York, 10065-4870, United States

  • Yichang Central Peoples Hospitaljiangnan Branch

    ACTIVE_NOT_RECRUITING

    Yichang, Hubei, 443001, China

  • Yokohama Municipal Citizens Hospital

    RECRUITING

    Yokohama, 221-0855, Japan

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