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Advanced Solid TumorPhase 1NCT06589596

An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors

A Phase 1 study testing BGB-58067, BG-89894 and RAS(ON) Inhibitors in people with Advanced Solid Tumor, run by BeOne Medicines at 101 sites in 11 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

This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 alone, in combination with BG-89894 (discontinued), in combination with standard of care therapy, and in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
BGB-58067, BG-89894 and RAS(ON) Inhibitors
Could I receive a placebo?
No, everyone receives an active treatment
How many people
695 participants
Where
101 sitesin 11 countries
Study dates
10 Jan 2025to 31 Aug 2028
Phase
Phase 1
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

  • Participants must sign the Informed Consent Form 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; documented RAS mutation status or KRAS mutation is required for selected cohorts
  • 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

Who cannot join

  • Prior treatment with any 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
Show all 15Show fewer
  • Serologically active hepatitis B or C infection
  • Known human immunodeficiency virus (HIV) infection. Participants with treated HIV infection may be included in Phase 1b if they meet certain criteria
  • High cardiovascular risk factors
  • QT interval corrected by Fridericia's method (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.

Trial locations and contacts

101 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Study Director contact

1.877.828.5568

clinicaltrials@beonemed.com

101 sites in 11 countries

China47 sites, 47 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Recruiting

  • Beijing Chest Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101149

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Recruiting

  • Sichuan Cancer Hospitaltianfu Branch

    Chengdu, Sichuan, 610000

    Recruiting

  • Sichuan Cancer Hospital and Institute

    Chengdu, Sichuan, 610041

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Recruiting

  • Deyangs People Hospital

    Deyang, Sichuan, 618000

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

    Recruiting

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

    Guangzhou, Guangdong, 510245

    Recruiting

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong, 510405

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Recruiting

  • Zhejiang Provincial Peoples Hospital

    Hangzhou, Zhejiang, 310014

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

    Recruiting

  • Jinan Central Hospital

    Jinan, Shandong, 250013

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Recruiting

  • Meizhou People Hospital

    Meizhou, Guangdong, 514031

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Recruiting

  • Guangxi Medical University Cancer Hospital Wuxiang Branch

    Nanning, Guangxi, 530201

    Recruiting

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Recruiting

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

    Recruiting

  • Shanghai East Hospital Branch Hospital

    Shanghai, Shanghai Municipality, 200123

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Recruiting

  • Fudan University Shanghai Cancer Centerpudong

    Shanghai, Shanghai Municipality, 201321

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

    Recruiting

  • The Second Affiliated Hospital of Shandong First Medical University

    Taian, Shandong, 271099

    Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013

    Recruiting

  • Taizhou Hospital of Zhejiang Provinceenze Branch

    Taizhou, Zhejiang, 318050

    Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

    Recruiting

  • Weifang Peoples Hospital Beichen Branch

    Weifang, Shandong, 261057

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Recruiting

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

    Wuhan, Hubei, 430022

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Recruiting

  • Yichang Central Peoples Hospital

    Yichang, Hubei, 443003

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Recruiting

Other trials in China

United States12 sites, 12 recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215-5418

    Recruiting

  • Adventhealth

    Celebration, Florida, 34747-4606

    Recruiting

  • Next Oncology Virginia

    Fairfax, Virginia, 22031

    Recruiting

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009

    Recruiting

  • Next Oncology Dallas

    Irving, Texas, 75039-2743

    Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

    Recruiting

  • Usc Norris Comprehensive Cancer Center (Nccc)

    Los Angeles, California, 90089-1019

    Recruiting

  • Tennessee Oncology, Pllc Nashville

    Nashville, Tennessee, 37203

    Recruiting

  • Nyu Langone Health

    New York, New York, 10016-2708

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Recruiting

  • Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania, 19107-4307

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110-1010

    Recruiting

Other trials in United States

Brazil10 sites, 10 recruiting

  • Fundacao Pio Xii Hospital de Amor de Barretos

    Barretos, 14.784-400

    Recruiting

  • Fundacao Universidade de Caxias Do Sul

    Caxias do Sul, 95070-560

    Recruiting

  • Liga Norte Riograndene Contra O Cancer

    Natal, 59062-000

    Recruiting

  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

    Porto Alegre, 90110-270

    Recruiting

  • Hospital Sao Lucas Da Pucrs

    Porto Alegre, 90610-000

    Recruiting

  • Ensino E Terapia de Inovacao Clinica Amo Etica

    Salvador, 41950-640

    Recruiting

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

    São Paulo, 01246-000

    Recruiting

  • Nucleo de Pesquisa E Ensino Da Rede Sao Camilo

    São Paulo, 04014-002

    Recruiting

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652-900

    Recruiting

  • Hospital Santa Rita de Cassia Afecc

    Vitória, 29043-260

    Recruiting

Other trials in Brazil

South Korea6 sites, 6 recruiting

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351

    Recruiting

  • The Catholic University of Korea, St Vincents Hospital

    PaldalGu SuwonSi, Gyeonggi-do, 16247

    Recruiting

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

    Recruiting

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505

    Recruiting

Other trials in South Korea

Australia5 sites, 5 recruiting

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, NSW 2148

    Recruiting

  • Monash Health

    Clayton, Victoria, VIC 3168

    Recruiting

  • Austin Health

    Heidelberg, Victoria, VIC 3084

    Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia, WA 6009

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, QLD 4102

    Recruiting

Other trials in Australia

France5 sites, 5 recruiting

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    Bordeaux, 33076

    Recruiting

  • Institut Paoli Calmettes

    Marseille, 13009

    Recruiting

  • Institut Curie Paris

    Paris, 75005

    Recruiting

  • Institut de Cancerologie de Louest

    Saint-Herblain, 44800

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94800

    Recruiting

Other trials in France

Malaysia5 sites, 5 recruiting

  • Hospital Pulau Pinang

    George Town, 10990

    Recruiting

  • Hospital Raja Perempuan Zainab Ii

    Johor Bahru, 15586

    Recruiting

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

    Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

    Recruiting

  • Sarawak General Hospital

    Kuching, 93586

    Recruiting

Other trials in Malaysia

Thailand5 sites, 5 recruiting

  • Ramathibodi Hospital Mahidol University

    Bangkok, 10400

    Recruiting

  • Siriraj Hospital

    Bangkok, 10700

    Recruiting

  • Songklanagarind Hospital (Prince of Songkhla University)

    Hat Yai, 90110

    Recruiting

  • Srinagarind Hospital (Khon Kaen University)

    Muang, 40002

    Recruiting

  • Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)

    Muang, 50200

    Recruiting

Other trials in Thailand

Spain4 sites, 4 recruiting

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035

    Recruiting

  • Start Madrid Fundacion Jimenez Diaz

    Madrid, 28040

    Recruiting

  • Hospital Universitario Hm Madrid Sanchinarro

    Madrid, 28050

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28240

    Recruiting

Other trials in Spain

Denmark1 site, 1 recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Recruiting

Other trials in Denmark

Moldova1 site, 1 recruiting

  • The Institute of Oncology, Arensia Exploratory Medicine

    Chisinau, 2025

    Recruiting

Other trials in Moldova

About this study

Official title: A Phase 1a/b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of PRMT5 Inhibitor BGB-58067 Alone and in Combination With Anticancer Agents in Patients With Advanced Solid Tumors

This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 alone, in combination with BG-89894 (discontinued), in combination with standard of care therapy, and in combination with novel anticancer therapies in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.

Read the detailed description

A solid tumor is an abnormal lump or mass of tissue that forms when cells grow out of control. Solid tumors can develop in organs, bones, or soft tissues. An advanced or metastatic solid tumor is a cancer that has either grown into nearby tissues (advanced) or spread to distant parts of the body (metastatic).

BGB-58067 works by blocking a protein in the body called PRMT5. Although all cells need PRMT5 to function normally, cancer cells depend on it more heavily for growth and survival. In some cancers (about 15% of all cancers), a gene called MTAP is deficient, leading to the buildup of a substance called methylthioadenosine (MTA). This buildup makes the cancer cells more sensitive to blocking PRMT5. The aim of this approach is to selectively target cancer cells with MTAP deficiency, reduce harm to healthy tissues, and reduce side effects.

The purpose of this study is to test how safe and helpful BGB-58067 is when given alone, in combination with standard of care therapy, and in combination with novel anticancer therapies in participants with advanced solid tumors and with MTAP deficiency. The main goals of this study are to ensure the treatments are safe by monitoring side effects and to understand how well patients respond to the treatment and whether their cancers shrink or disappear.

This study consists of dose escalation and dose expansion parts. During the dose escalation part, the study doctors will test different doses of the study drug(s) to find the recommended dose that people can take without having serious side effects. During the dose expansion part, the study doctors will test the study drug(s) in a larger number of people using the dose(s) identified from dose escalation.

The overall time to participate in this study is up to approximately 2 years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.

Note: Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Being tested
BGB-58067, BG-89894, Standard of Care Therapy, RAS(ON) Inhibitors
Keywords
advanced solid tumor, BGB-58067, MTAP deficiency

What participants receive

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

  • BGB-58067Drug

    Planned doses administered on specified days per protocol.

  • BG-89894Drug

    Planned doses administered on specified days per protocol.

  • Standard of Care TherapyDrug

    Administered in accordance with relevant local guidelines and/or prescribing information.

  • RAS(ON) InhibitorsDrug

    Planned doses administered on specified days per protocol.

Study groups in NCT06589596
Study groupRoleWhat they receive
Phase 1a: BGB-58067 Monotherapy Dose Escalation and Safety ExpansionExperimentalSequential cohorts of increasing dose levels of BGB-58067 as monotherapy will be evaluated.
Receives: Drug: BGB-58067
Phase 1a: BGB-58067 + BG-89894 Combination Therapy Dose EscalationExperimentalSequential cohorts of increasing dose levels of BGB-58067 in combination with BG-89894 will be evaluated. Enrollment in this combination has been discontinued.
Receives: Drug: BGB-58067; Drug: BG-89894
Phase 1a: BGB-58067 + Standard of Care Combination Therapy Dose EscalationExperimentalSequential cohorts of increasing dose levels of BGB-58067 in combination with standard of care therapy will be evaluated.
Receives: Drug: BGB-58067; Drug: Standard of Care Therapy
Phase 1b: BGB-58067 Monotherapy Dose Expansion and OptimizationExperimentalRecommended Dose(s) for Expansion (RDFE[s]) of BGB-58067 alone will be evaluated for selected indications and regimen(s) based on emerging data.
Receives: Drug: BGB-58067
Phase 1b: BGB-58067 + Standard of Care Combination Therapy Dose Expansion and OptimizationExperimentalRDFE(s) of BGB-58067 in combination with standard of care therapy will be evaluated for selected indications and regimen(s) based on emerging data.
Receives: Drug: BGB-58067; Drug: Standard of Care Therapy
Phase 1b: BGB-58067 + Novel Anticancer Therapies Combination Therapy Dose Expansion and OptimizationExperimentalRDFE(s) of BGB-58067 in combination with novel anticancer therapies will be evaluated for selected indications and regimen(s) based on emerging data.
Receives: Drug: BGB-58067; Drug: RAS(ON) Inhibitors

What is being measured

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

  1. Phase 1a: Number of Participants with Adverse Events and Serious Adverse Events

    Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments.

    Measured: From first dose of the study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 13 months)

  2. Phase 1a: Number of Participants with Adverse Events that meet Dose-Limiting Toxicity (DLT) criteria

    Measured: Approximately 1 month

  3. Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy

    MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached. Note: BGB-58067 + BG-89894 combination has been discontinued.

    Measured: Approximately 1 month

  4. Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy

    RDFE of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy will be determined based upon the MTD or MAD. Note: BGB-58067 + BG-89894 combination has been discontinued.

    Measured: Approximately 13 months

  5. Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-58067 alone and in combination with standard of care therapy or novel anticancer therapies

    RP2D established from Phase 1a for BGB-58067 alone and in combination with standard of care therapy for administration in selected tumor types.

    Measured: Approximately 2 years

  6. Phase 1b: Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR), as assessed by the investigator.

    Measured: Approximately 2 years

Secondary outcomes (14)

  1. Phase 1a: Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with confirmed CR or PR, as assessed by the investigator.

    Measured: Approximately 2 years

  2. Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BGB-58067

    Measured: Approximately 2 months

  3. Phase 1a and 1b: Minimum observed plasma concentration (Cmin) of BGB-58067

    Measured: Approximately 9 months

  4. Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BGB-58067

    Measured: Approximately 2 months

  5. Phase 1a and 1b: Apparent oral clearance (CL/F) for BGB-58067

    Measured: Approximately 2 months

  6. Phase 1a and 1b: Half-life (t1/2) of BGB-58067

    Measured: Approximately 2 months

  7. Phase 1a and 1b: Area under the concentration-time curve (AUC) of BGB-58067

    Measured: Approximately 2 months

  8. Phase 1a and 1b: Apparent volume of distribution (Vz/F) for BGB-58067

    Measured: Approximately 2 months

  9. Phase 1a and 1b: Accumulation ratio (AR) for BGB-58067

    Measured: Approximately 2 months

  10. Phase 1a and 1b: Plasma concentrations of BGB-58067

    Measured: Approximately 9 months

  11. Phase 1a and 1b: Duration of Response (DOR)

    DOR is defined as the time from the first determination of an objective response until first documentation of progression or death, whichever occurs first, as assessed by the investigator.

    Measured: Approximately 2 years

  12. Phase 1a and 1b: Disease Control Rate (DCR)

    DCR is defined as the percentage of participants with best overall response of a CR, PR, and stable disease, as assessed by the investigator.

    Measured: Approximately 2 years

  13. Phase 1b: Number of Participants with AEs and SAEs

    Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments.

    Measured: From first dose of the study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 13 months)

  14. Phase 1b: Progression-Free Survival (PFS)

    PFS is defined as the time from the date of the first dose of study drug to the date of first documentation of progressive disease assessed by investigator or death, whichever occurs first, as assessed by the investigator.

    Measured: Approximately 2 years

Timeline

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

  1. First posted19 Sep 2024
  2. Study start10 Jan 2025
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Aug 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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
695 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06589596
Sponsor's protocol ID
BGB-58067-101
Other IDs
2024-515307-19-00, CTR20244451
Status last verified
Oct 2026
First submitted
6 Sep 2024
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BGB-58067, BG-89894 and RAS(ON) Inhibitors in people with Advanced Solid Tumor, run by BeOne Medicines at 101 sites in 11 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 7 inclusion and 15 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in China, United States, Brazil, South Korea, Australia and 6 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Study Director (1.877.828.5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a: Number of Participants with Adverse Events and Serious Adverse Events (time frame: From first dose of the study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 13 months)). The study lists 6 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 NCT06589596.

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 20 Oct 2026.

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