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New hope for Hard-to-Treat cancers: first human trial of BGB-58067 begins

NCT ID NCT06589596

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 15, 2026 · Updated 7 times

Summary

This early-stage trial is testing a new drug called BGB-58067, alone or with other cancer treatments, in people with advanced solid tumors that have a specific genetic change (MTAP deficiency). The study aims to find the safest dose and see if the drug can shrink tumors. About 525 participants will take part across multiple centers.

What this could mean

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

Active substance
BGB-58067 (a PRMT5 inhibitor drug)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have a specific genetic marker (MTAP deficiency).
What could go wrong
This is a very early (Phase 1) trial, so the drug may not work or may cause unexpected side effects. It is also only for people with a specific tumor type, so results may not apply to all cancers.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 525 people

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

Started

Jan 2025

Expected to finish

Sep 2027

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: * Participants must sign the ICF and be capable of giving written informed consent * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Scale (KPS) ≥ 70 * Life expectancy ≥ 3 months * Evidence of homozygous loss of MTAP or lost MTAP expression in the tumor tissue * Able to provide tumor sample to meet the minimum tissue requirement for central MTAP deficiency testing * Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose diseases have progressed or recurred after receiving standard systemic therapy or radiotherapy, or for whom standard systemic therapy is not available or tolerated, or would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard treatment in the opinion of the investigator; participants with advanced, metastatic, or unresectable solid tumors who have not received prior systemic treatment or have received one cycle of standard-of-care therapies will be enrolled in selected cohorts * Adequate organ function Exclusion Criteria: * Prior treatment with any methylthioadenosine (MTA)-cooperative PRMT5 inhibitor or methionine adenosyltransferase 2a (MAT2A) inhibitor * Active leptomeningeal disease or symptomatic spinal cord compression * Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage * Any malignancy ≤ 2 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively * Significantly impaired pulmonary function * Clinically significant infections * Serologically active hepatitis B or C infection * Known HIV infection. Participants with treated HIV infection may be included in Phase 1b if they meet certain criteria * High cardiovascular risk factors * QTcF \> 470 ms based on the screening triplicate 12-lead ECG records and/or a history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, or a family history of Long QT Syndrome) * Toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized * Participants who are unable to swallow or with disease/procedure significantly affecting gastrointestinal function * Female participants who are pregnant or are breastfeeding * Concurrent participation in another therapeutic clinical study (participation in observational or noninterventional studies is allowed) Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Advanced solid tumor

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

    101 sites in 11 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

  • Adventhealth

    RECRUITING

    Celebration, Florida, 34747-4606, United States

  • Asan Medical Center

    RECRUITING

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Austin Health

    RECRUITING

    Heidelberg, Victoria, VIC 3084, Australia

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Beijing Chest Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 101149, China

  • Blacktown Cancer and Haematology Centre

    RECRUITING

    Blacktown, New South Wales, NSW 2148, Australia

  • Cancer Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • Cancer and Blood Specialty Clinic

    RECRUITING

    Los Alamitos, California, 90720, United States

  • 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

  • Chongqing University Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400030, China

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215-5418, United States

  • Deyangs People Hospital

    RECRUITING

    Deyang, Sichuan, 618000, China

  • Ensino E Terapia de Inovacao Clinica Amo Etica

    RECRUITING

    Salvador, 41950-640, Brazil

  • Fudan University Shanghai Cancer Centerpudong

    RECRUITING

    Shanghai, Shanghai Municipality, 201321, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Fundacao Pio Xii Hospital de Amor de Barretos

    RECRUITING

    Barretos, 14.784-400, Brazil

  • Fundacao Universidade de Caxias Do Sul

    RECRUITING

    Caxias do Sul, 95070-560, Brazil

  • Guangxi Medical University Cancer Hospital Wuxiang Branch

    RECRUITING

    Nanning, Guangxi, 530201, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150000, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 28240, Spain

  • Hospital Kuala Lumpur

    RECRUITING

    Kuala Lumpur, 50586, Malaysia

  • Hospital Pulau Pinang

    RECRUITING

    George Town, 10990, Malaysia

  • Hospital Raja Perempuan Zainab Ii

    RECRUITING

    Johor Bahru, 15586, Malaysia

  • Hospital Santa Rita de Cassia Afecc

    RECRUITING

    Vitória, 29043-260, Brazil

  • Hospital Sao Lucas Da Pucrs

    RECRUITING

    Porto Alegre, 90610-000, Brazil

  • Hospital Universitario Hm Madrid Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • Hospital Universitario Vall Dhebron

    RECRUITING

    Barcelona, 08035, Spain

  • Huashan Hospital Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, 410013, China

  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

    RECRUITING

    São Paulo, 01246-000, Brazil

  • Institut Curie Paris

    RECRUITING

    Paris, 75005, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, 13009, France

  • Institut de Cancerologie de Louest

    RECRUITING

    Saint-Herblain, 44800, France

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, Jiangxi, 330029, China

  • Jinan Central Hospital

    RECRUITING

    Jinan, Shandong, 250013, China

  • Liga Norte Riograndene Contra O Cancer

    RECRUITING

    Natal, 59062-000, Brazil

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, WA 6009, Australia

  • Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)

    RECRUITING

    Muang, 50200, Thailand

  • Meizhou People Hospital

    RECRUITING

    Meizhou, Guangdong, 514031, China

  • Monash Health

    RECRUITING

    Clayton, Victoria, VIC 3168, Australia

  • Next Oncology Dallas

    RECRUITING

    Irving, Texas, 75039-2743, United States

  • Next Oncology Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Nucleo de Pesquisa E Ensino Da Rede Sao Camilo

    RECRUITING

    São Paulo, 04014-002, Brazil

  • Nyu Langone Health

    RECRUITING

    New York, New York, 10016-2708, United States

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, QLD 4102, Australia

  • Ramathibodi Hospital Mahidol University

    RECRUITING

    Bangkok, 10400, Thailand

  • Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

  • Samsung Medical Center

    RECRUITING

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Sarawak General Hospital

    RECRUITING

    Kuching, 93586, Malaysia

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, 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

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, 250117, China

  • Shanghai East Hospital Branch Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200123, China

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • Shanxi Provincial Cancer Hospital

    RECRUITING

    Taiyuan, Shanxi, 030013, China

  • Sichuan Cancer Hospital and Institute

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Sichuan Cancer Hospitaltianfu Branch

    RECRUITING

    Chengdu, Sichuan, 610000, China

  • Sidney Kimmel Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107-4307, United States

  • Siriraj Hospital

    RECRUITING

    Bangkok, 10700, Thailand

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    RECRUITING

    São Paulo, 05652-900, Brazil

  • Songklanagarind Hospital (Prince of Songkhla University)

    RECRUITING

    Hat Yai, 90110, Thailand

  • Srinagarind Hospital (Khon Kaen University)

    RECRUITING

    Muang, 40002, Thailand

  • Start Madrid Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)

    RECRUITING

    Guangzhou, Guangdong, 510245, China

  • Sun Yat Sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • Taizhou Hospital of Zhejiang Provinceenze Branch

    RECRUITING

    Taizhou, Zhejiang, 318050, China

  • Tennessee Oncology, Pllc Nashville

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The Catholic University of Korea, St Vincents Hospital

    RECRUITING

    PaldalGu SuwonSi, Gyeonggi-do, 16247, South Korea

  • The First Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510120, China

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    RECRUITING

    Guangzhou, Guangdong, 510405, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110001, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130021, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050011, China

  • The Institute of Oncology, Arensia Exploratory Medicine

    RECRUITING

    Chisinau, 2025, Moldova

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The Second Affiliated Hospital of Shandong First Medical University

    RECRUITING

    Taian, Shandong, 271099, China

  • The Second Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230601, China

  • The University of Texas Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-4009, United States

  • Tianjin Medical University Cancer Institute and Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

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

    RECRUITING

    Wuhan, Hubei, 430022, China

  • University Malaya Medical Centre

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • Usc Norris Comprehensive Cancer Center (Nccc)

    RECRUITING

    Los Angeles, California, 90089-1019, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110-1010, United States

  • Weifang Peoples Hospital Beichen Branch

    RECRUITING

    Weifang, Shandong, 261057, China

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Yichang Central Peoples Hospital

    RECRUITING

    Yichang, Hubei, 443003, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310022, China

  • Zhejiang Provincial Peoples Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310014, China

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