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

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), and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: BGB-58067; Drug: BG-89894; Drug: Standard of Care Therapy

Detailed Description

BGB-58067 is a new drug designed to target a specific protein called protein arginine methyltransferase 5 (PRMT5). This protein is involved in many cell activities and can promote cancer growth when it is overactive. High levels of PRMT5 are linked to poor outcomes in several types of cancer.

This new study will check how safe and helpful a potential anticancer drug called BGB-58067 is. This drug will be tested alone, in combination with BG-89894 (discontinued), and in combination with standard of care therapy in participants with advanced solid tumors and with MTAP deficiency.

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.

• Study Type: Interventional
• Enrollment (Estimated): 525
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 1.877.828.5568; Email: clinicaltrials@beonemed.com

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, NSW 2148
      • Recruiting
      • Blacktown Cancer and Haematology Centre
  • Queensland
    • Woolloongabba, Queensland, Australia, QLD 4102
      • Recruiting
      • Princess Alexandra Hospital
  • Victoria
    • Clayton, Victoria, Australia, VIC 3168
      • Recruiting
      • Monash Health
    • Heidelberg, Victoria, Australia, VIC 3084
      • Recruiting
      • Austin Health
  • Western Australia
    • Nedlands, Western Australia, Australia, WA 6009
      • Recruiting
      • Linear Clinical Research
• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • Recruiting
      • The Second Hospital of Anhui Medical University
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
    • Beijing, Beijing Municipality, China, 101149
      • Recruiting
      • Beijing Chest Hospital, Capital Medical University
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Recruiting
      • Chongqing University Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Cancer Hospital
    • Xiamen, Fujian, China, 361003
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510405
      • Recruiting
      • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat Sen University Cancer Center
    • Guangzhou, Guangdong, China, 510245
      • Recruiting
      • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
    • Meizhou, Guangdong, China, 514031
      • Recruiting
      • Meizhou People Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530201
      • Recruiting
      • Guangxi Medical University Cancer Hospital Wuxiang Branch
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Cancer Hospital
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Recruiting
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
    • Yichang, Hubei, China, 443003
      • Recruiting
      • Yichang Central Peoples Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu Province Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Recruiting
      • Jiangxi Cancer Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Recruiting
      • The First Hospital of China Medical University
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital
    • Taian, Shandong, China, 271099
      • Recruiting
      • The Second Affiliated Hospital of Shandong First Medical University
    • Weifang, Shandong, China, 261057
      • Recruiting
      • Weifang Peoples Hospital Beichen Branch
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200123
      • Recruiting
      • Shanghai East Hospital Branch Hospital
    • Shanghai, Shanghai Municipality, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital
    • Shanghai, Shanghai Municipality, China, 201321
      • Recruiting
      • Fudan University Shanghai Cancer Centerpudong
    • Shanghai, Shanghai Municipality, China, 200025
      • Recruiting
      • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Recruiting
      • Shanxi Provincial Cancer Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital, Sichuan University
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Sichuan Cancer Hospital and Institute
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • Sichuan Cancer Hospitaltianfu Branch
    • Deyang, Sichuan, China, 618000
      • Recruiting
      • Deyangs People Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310014
      • Recruiting
      • Zhejiang Provincial Peoples Hospital
    • Taizhou, Zhejiang, China, 318050
      • Recruiting
      • Taizhou Hospital of Zhejiang Provinceenze Branch
• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet
• France
  • Bordeaux, France, 33000
    • Recruiting
    • Centre de Lutte Contre Le Cancer Institut Bergonie
  • Marseille, France, 13009
    • Recruiting
    • Institut Paoli Calmettes
  • Paris, France, 75005
    • Recruiting
    • Institut Curie Paris
  • Saint-Herblain, France, 44800
    • Recruiting
    • Institut de Cancerologie de Louest
  • Villejuif, France, 94800
    • Recruiting
    • Institut Gustave Roussy
• Malaysia
  • George Town, Malaysia, 10990
    • Recruiting
    • Hospital Pulau Pinang
  • Johor Bahru, Malaysia, 15586
    • Recruiting
    • Hospital Raja Perempuan Zainab II
  • Kuala Lumpur, Malaysia, 59100
    • Recruiting
    • University Malaya Medical Centre
  • Kuala Lumpur, Malaysia, 50586
    • Recruiting
    • Hospital Kuala Lumpur
  • Kuching, Malaysia, 93586
    • Recruiting
    • Sarawak General Hospital
• Moldova
  • Chisinau, Moldova, 2025
    • Recruiting
    • The Institute of Oncology, Arensia Exploratory Medicine
• South Korea
  • Gyeonggi-do
    • PaldalGu SuwonSi, Gyeonggi-do, South Korea, 16247
      • Recruiting
      • The Catholic University of Korea, St Vincents Hospital
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
  • Seoul Teugbyeolsi
    • GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
      • Recruiting
      • Samsung Medical Center
    • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
      • Recruiting
      • Severance Hospital Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital
    • SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
      • Recruiting
      • Asan Medical Center
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall Dhebron
  • Madrid, Spain, 28040
    • Recruiting
    • Start Madrid Fundacion Jimenez Diaz
  • Madrid, Spain, 28050
    • Recruiting
    • Hospital Universitario HM Madrid Sanchinarro
  • Madrid, Spain, 28240
    • Recruiting
    • Hospital Clinico San Carlos
• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Siriraj Hospital
  • Bangkok, Thailand, 10400
    • Recruiting
    • Ramathibodi Hospital Mahidol University
  • Hat Yai, Thailand, 90110
    • Recruiting
    • Songklanagarind Hospital (Prince of Songkhla University)
  • Muang, Thailand, 40002
    • Recruiting
    • Srinagarind Hospital (Khon Kaen University)
  • Muang, Thailand, 50200
    • Recruiting
    • Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
• United States
  • California
    • Los Angeles, California, United States, 90089-1019
      • Recruiting
      • Usc Norris Comprehensive Cancer Center (Nccc)
  • Florida
    • Celebration, Florida, United States, 34747-4606
      • Recruiting
      • AdventHealth
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5418
      • Recruiting
      • Dana Farber Cancer Institute
  • Missouri
    • St Louis, Missouri, United States, 63110-1010
      • Recruiting
      • Washington University School of Medicine
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center
    • New York, New York, United States, 10016-2708
      • Recruiting
      • NYU Langone Health
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107-4307
      • Recruiting
      • Sidney Kimmel Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Oncology, Pllc Nashville
  • Texas
    • Houston, Texas, United States, 77030-4009
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
    • Irving, Texas, United States, 75039-2743
      • Recruiting
      • NEXT Dallas
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Next Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1a: BGB-58067 Monotherapy Dose Escalation and Safety Expansion; Sequential cohorts of increasing dose levels of BGB-58067 as monotherapy will be evaluated.	Drug: BGB-58067; Planned doses administered on specified days per protocol.
Experimental: Phase 1a: BGB-58067 + Standard of Care Combination Therapy Dose Escalation; Sequential cohorts of increasing dose levels of BGB-58067 in combination with standard of care therapy will be evaluated.	Drug: BGB-58067; Planned doses administered on specified days per protocol.; Drug: Standard of Care Therapy; Administered in accordance with relevant local guidelines and/or prescribing information.
Experimental: Phase 1a: BGB-58067 + BG-89894 Combination Therapy Dose Escalation; Sequential cohorts of increasing dose levels of BGB-58067 in combination with BG-89894 will be evaluated. Enrollment in this combination has been discontinued.	Drug: BGB-58067; Planned doses administered on specified days per protocol.; Drug: BG-89894; Planned doses administered on specified days per protocol.
Experimental: Phase 1b: Dose Expansion and Optimization; Recommended Dose(s) for Expansion (RDFE[s]) of BGB-58067 alone and in combination with standard of care therapy will be evaluated for selected indications and regimen(s) based on emerging data.	Drug: BGB-58067; Planned doses administered on specified days per protocol.; Drug: Standard of Care Therapy; Administered in accordance with relevant local guidelines and/or prescribing information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately 2 years
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.	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)
Phase 1a: Number of Participants with Adverse Events that meet Dose-Limiting Toxicity (DLT) criteria		Approximately 1 month
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.	Approximately 1 month
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.	Approximately 13 months
Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-58067 alone and in combination with standard of care therapy	RP2D established from Phase 1a for BGB-58067 alone and in combination with standard of care therapy for administration in selected tumor types.	Approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a: Objective Response Rate (ORR)	ORR is defined as the percentage of participants with confirmed CR or PR, as assessed by the investigator.	Approximately 2 years
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.	Approximately 2 years
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.	Approximately 2 years
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.	Approximately 2 years
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BGB-58067		Approximately 2 months
Phase 1a and 1b: Minimum observed plasma concentration (Cmin) of BGB-58067		Approximately 9 months
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BGB-58067		Approximately 2 months
Phase 1a and 1b: Apparent oral clearance (CL/F) for BGB-58067		Approximately 2 months
Phase 1a and 1b: Half-life (t1/2) of BGB-58067		Approximately 2 months
Phase 1a and 1b: Area under the concentration-time curve (AUC) of BGB-58067		Approximately 2 months
Phase 1a and 1b: Apparent volume of distribution (Vz/F) for BGB-58067		Approximately 2 months
Phase 1a and 1b: Accumulation ratio (AR) for BGB-58067		Approximately 2 months
Phase 1a and 1b: Plasma concentrations of BGB-58067		Approximately 9 months
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.	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)

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 6, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: advanced solid tumor; BGB-58067; MTAP deficiency
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: BGB-58067-101; 2024-515307-19-00 (Ctis); CTR20244451 (Registry Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No