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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: BeOne Medicines • ClinicalTrials.gov ID: NCT06589596

Registry updated: 2026-10-20
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Description

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.

Interventions

  • BGB-58067 (Drug)
    Planned doses administered on specified days per protocol.
  • BG-89894 (Drug)
    Planned doses administered on specified days per protocol.
  • Standard of Care Therapy (Drug)
    Administered in accordance with relevant local guidelines and/or prescribing information.
  • RAS(ON) Inhibitors (Drug)
    Planned doses administered on specified days per protocol.

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.

Conditions

Advanced Solid Tumor

Locations

  • Cancer and Blood Specialty Clinic — Los Alamitos, California, United States
  • Usc Norris Comprehensive Cancer Center (Nccc) — Los Angeles, California, United States
  • Adventhealth — Celebration, Florida, United States
  • Dana Farber Cancer Institute — Boston, Massachusetts, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Nyu Langone Health — New York, New York, United States
  • Columbia University Medical Center — New York, New York, United States
  • Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States
  • Tennessee Oncology, Pllc Nashville — Nashville, Tennessee, United States
  • The University of Texas Md Anderson Cancer Center — Houston, Texas, United States
  • Next Oncology Dallas — Irving, Texas, United States
  • Next Oncology Virginia — Fairfax, Virginia, United States
  • Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia
  • Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
  • Monash Health — Clayton, Victoria, Australia
  • Austin Health — Heidelberg, Victoria, Australia
  • Linear Clinical Research — Nedlands, Western Australia, Australia
  • Fundacao Pio Xii Hospital de Amor de Barretos — Barretos, Brazil
  • Fundacao Universidade de Caxias Do Sul — Caxias do Sul, Brazil
  • Liga Norte Riograndene Contra O Cancer — Natal, Brazil
  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus — Porto Alegre, Brazil
  • Hospital Sao Lucas Da Pucrs — Porto Alegre, Brazil
  • Ensino E Terapia de Inovacao Clinica Amo Etica — Salvador, Brazil
  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira — São Paulo, Brazil
  • Nucleo de Pesquisa E Ensino Da Rede Sao Camilo — São Paulo, Brazil
  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein — São Paulo, Brazil
  • Hospital Santa Rita de Cassia Afecc — Vitória, Brazil
  • The Second Hospital of Anhui Medical University — Hefei, Anhui, China
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China
  • Beijing Cancer Hospital — Beijing, Beijing Municipality, China
  • Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
  • Beijing Chest Hospital, Capital Medical University — Beijing, Beijing Municipality, China
  • Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China
  • Fujian Cancer Hospital — Fuzhou, Fujian, China
  • The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China
  • Sun Yat Sen University Cancer Center — Guangzhou, Guangdong, China
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) — Guangzhou, Guangdong, China
  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou, Guangdong, China
  • Meizhou People Hospital — Meizhou, Guangdong, China
  • Guangxi Medical University Cancer Hospital Wuxiang Branch — Nanning, Guangxi, China
  • The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
  • Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
  • Henan Cancer Hospital — Zhengzhou, Henan, China
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
  • Hubei Cancer Hospital — Wuhan, Hubei, China
  • Yichang Central Peoples Hospital — Yichang, Hubei, China
  • Hunan Cancer Hospital — Changsha, Hunan, China
  • Jiangsu Province Hospital — Nanjing, Jiangsu, China
  • The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
  • Jiangxi Cancer Hospital — Nanchang, Jiangxi, China
  • The First Hospital of Jilin University — Changchun, Jilin, China
  • The First Hospital of China Medical University — Shenyang, Liaoning, China
  • Jinan Central Hospital — Jinan, Shandong, China
  • Shandong Cancer Hospital — Jinan, Shandong, China
  • The Second Affiliated Hospital of Shandong First Medical University — Taian, Shandong, China
  • Weifang Peoples Hospital Beichen Branch — Weifang, Shandong, China
  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
  • Huashan Hospital Fudan University — Shanghai, Shanghai Municipality, China
  • Shanghai East Hospital Branch Hospital — Shanghai, Shanghai Municipality, China
  • Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China
  • Fudan University Shanghai Cancer Centerpudong — Shanghai, Shanghai Municipality, China
  • Shanxi Provincial Cancer Hospital — Taiyuan, Shanxi, China
  • Sichuan Cancer Hospitaltianfu Branch — Chengdu, Sichuan, China
  • Sichuan Cancer Hospital and Institute — Chengdu, Sichuan, China
  • West China Hospital, Sichuan University — Chengdu, Sichuan, China
  • Deyangs People Hospital — Deyang, Sichuan, China
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
  • Zhejiang Provincial Peoples Hospital — Hangzhou, Zhejiang, China
  • Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China
  • Taizhou Hospital of Zhejiang Provinceenze Branch — Taizhou, Zhejiang, China
  • The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China
  • Rigshospitalet — Copenhagen, Denmark
  • Centre de Lutte Contre Le Cancer Institut Bergonie — Bordeaux, France
  • Institut Paoli Calmettes — Marseille, France
  • Institut Curie Paris — Paris, France
  • Institut de Cancerologie de Louest — Saint-Herblain, France
  • Institut Gustave Roussy — Villejuif, France
  • Hospital Pulau Pinang — George Town, Malaysia
  • Hospital Raja Perempuan Zainab Ii — Johor Bahru, Malaysia
  • Hospital Kuala Lumpur — Kuala Lumpur, Malaysia
  • University Malaya Medical Centre — Kuala Lumpur, Malaysia
  • Sarawak General Hospital — Kuching, Malaysia
  • The Institute of Oncology, Arensia Exploratory Medicine — Chisinau, Moldova
  • The Catholic University of Korea, St Vincents Hospital — PaldalGu SuwonSi, Gyeonggi-do, South Korea
  • Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
  • Samsung Medical Center — GangnamGu, Seoul Teugbyeolsi, South Korea
  • Severance Hospital Yonsei University Health System — SeodaemunGu, Seoul Teugbyeolsi, South Korea
  • Seoul National University Hospital — Seoul, Seoul Teugbyeolsi, South Korea
  • Asan Medical Center — SongpaGu, Seoul Teugbyeolsi, South Korea
  • Hospital Universitario Vall Dhebron — Barcelona, Spain
  • Start Madrid Fundacion Jimenez Diaz — Madrid, Spain
  • Hospital Universitario Hm Madrid Sanchinarro — Madrid, Spain
  • Hospital Clinico San Carlos — Madrid, Spain
  • Ramathibodi Hospital Mahidol University — Bangkok, Thailand
  • Siriraj Hospital — Bangkok, Thailand
  • Songklanagarind Hospital (Prince of Songkhla University) — Hat Yai, Thailand
  • Srinagarind Hospital (Khon Kaen University) — Muang, Thailand
  • Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University) — Muang, Thailand
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record