Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06589596

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

Led by BeOne Medicines · Updated on 2026-05-12

525

Participants Needed

80

Research Sites

141 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must sign informed consent and be able to provide written consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Scale (KPS) score of 70 or higher
  • Life expectancy of at least 3 months
  • Evidence of homozygous loss or loss of MTAP expression in tumor tissue
  • Able to provide tumor sample meeting requirements for MTAP deficiency testing
  • Histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors with disease progression after standard therapy or lack of suitable standard treatment
  • Adequate organ function
Not Eligible

You will not qualify if you...

  • Prior treatment with any MTA-cooperative PRMT5 inhibitor or MAT2A inhibitor
  • Active leptomeningeal disease or symptomatic spinal cord compression
  • Uncontrollable pleural, pericardial effusion, or ascites requiring frequent drainage
  • Any malignancy within 2 years before first study drug dose except the cancer under study or curatively treated local recurrence
  • Significantly impaired lung function
  • Clinically significant infections
  • Serologically active hepatitis B or C infection
  • Known HIV infection (treated HIV may be allowed in Phase 1b under criteria)
  • High cardiovascular risk factors
  • QTcF over 470 ms or risk factors for torsade de pointes
  • Unresolved toxicities from prior anticancer therapy
  • Inability to swallow or significant gastrointestinal dysfunction
  • Pregnant or breastfeeding females
  • Participation in another therapeutic clinical trial (observational studies allowed)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 80 locations

1

Usc Norris Comprehensive Cancer Center (Nccc)

Los Angeles, California, United States, 90089-1019

Actively Recruiting

2

Adventhealth

Celebration, Florida, United States, 34747-4606

Actively Recruiting

3

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215-5418

Actively Recruiting

4

Washington University School of Medicine

St Louis, Missouri, United States, 63110-1010

Actively Recruiting

5

Nyu Langone Health

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

Actively Recruiting

6

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

7

Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States, 19107-4307

Actively Recruiting

8

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States, 77030-4009

Actively Recruiting

9

Next Dallas

Irving, Texas, United States, 75039-2743

Actively Recruiting

10

Next Virginia

Fairfax, Virginia, United States, 22031

Actively Recruiting

11

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia, NSW 2148

Actively Recruiting

12

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, QLD 4102

Actively Recruiting

13

Monash Health

Clayton, Victoria, Australia, VIC 3168

Actively Recruiting

14

Austin Health

Heidelberg, Victoria, Australia, VIC 3084

Actively Recruiting

15

Linear Clinical Research

Nedlands, Western Australia, Australia, WA 6009

Actively Recruiting

16

The Second Hospital of Anhui Medical University

Hefei, Anhui, China, 230601

Actively Recruiting

17

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

18

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

19

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 101149

Actively Recruiting

20

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China, 400030

Actively Recruiting

21

Fujian Cancer Hospital

Fuzhou, Fujian, China, 350014

Actively Recruiting

22

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China, 361003

Actively Recruiting

23

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

24

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

Guangzhou, Guangdong, China, 510245

Actively Recruiting

25

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China, 510405

Actively Recruiting

26

Meizhou People Hospital

Meizhou, Guangdong, China, 514031

Actively Recruiting

27

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi, China, 530201

Actively Recruiting

28

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China, 150000

Actively Recruiting

29

Henan Cancer Hospital

Zhengzhou, Henan, China, 450000

Actively Recruiting

30

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

Actively Recruiting

31

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

Wuhan, Hubei, China, 430022

Actively Recruiting

32

Hubei Cancer Hospital

Wuhan, Hubei, China, 430079

Actively Recruiting

33

Yichang Central Peoples Hospital

Yichang, Hubei, China, 443003

Actively Recruiting

34

Jiangsu Province Hospital

Nanjing, Jiangsu, China, 210029

Actively Recruiting

35

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China, 330029

Actively Recruiting

36

The First Hospital of Jilin University

Changchun, Jilin, China, 130021

Actively Recruiting

37

The First Hospital of China Medical University

Shenyang, Liaoning, China, 110001

Actively Recruiting

38

Shandong Cancer Hospital

Jinan, Shandong, China, 250117

Actively Recruiting

39

The Second Affiliated Hospital of Shandong First Medical University

Taian, Shandong, China, 271099

Actively Recruiting

40

Weifang Peoples Hospital Beichen Branch

Weifang, Shandong, China, 261057

Actively Recruiting

41

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

42

Shanghai East Hospital Branch Hospital

Shanghai, Shanghai Municipality, China, 200123

Actively Recruiting

43

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China, 200433

Actively Recruiting

44

Fudan University Shanghai Cancer Centerpudong

Shanghai, Shanghai Municipality, China, 201321

Actively Recruiting

45

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China, 030013

Actively Recruiting

46

Sichuan Cancer Hospitaltianfu Branch

Chengdu, Sichuan, China, 610000

Actively Recruiting

47

Sichuan Cancer Hospital and Institute

Chengdu, Sichuan, China, 610041

Actively Recruiting

48

West China Hospital, Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

49

Deyangs People Hospital

Deyang, Sichuan, China, 618000

Actively Recruiting

50

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China, 300060

Actively Recruiting

51

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

52

Zhejiang Provincial Peoples Hospital

Hangzhou, Zhejiang, China, 310014

Actively Recruiting

53

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

54

Taizhou Hospital of Zhejiang Provinceenze Branch

Taizhou, Zhejiang, China, 318050

Actively Recruiting

55

Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

56

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, France, 33000

Actively Recruiting

57

Institut Curie Paris

Paris, France, 75005

Actively Recruiting

58

Institut de Cancerologie de Louest

Saint-Herblain, France, 44800

Actively Recruiting

59

Institut Gustave Roussy

Villejuif, France, 94800

Actively Recruiting

60

Hospital Pulau Pinang

George Town, Malaysia, 10990

Actively Recruiting

61

Hospital Raja Perempuan Zainab Ii

Johor Bahru, Malaysia, 15586

Actively Recruiting

62

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia, 50586

Actively Recruiting

63

University Malaya Medical Centre

Kuala Lumpur, Malaysia, 59100

Actively Recruiting

64

Sarawak General Hospital

Kuching, Malaysia, 93586

Actively Recruiting

65

The Institute of Oncology, Arensia Exploratory Medicine

Chisinau, Moldova, 2025

Actively Recruiting

66

The Catholic University of Korea, St Vincents Hospital

PaldalGu SuwonSi, Gyeonggi-do, South Korea, 16247

Actively Recruiting

67

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea, 13620

Actively Recruiting

68

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea, 06351

Actively Recruiting

69

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722

Actively Recruiting

70

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea, 03080

Actively Recruiting

71

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea, 05505

Actively Recruiting

72

Hospital Universitario Vall Dhebron

Barcelona, Spain, 08035

Actively Recruiting

73

Start Madrid Fundacion Jimenez Diaz

Madrid, Spain, 28040

Actively Recruiting

74

Hospital Universitario Hm Madrid Sanchinarro

Madrid, Spain, 28050

Actively Recruiting

75

Hospital Clinico San Carlos

Madrid, Spain, 28240

Actively Recruiting

76

Ramathibodi Hospital Mahidol University

Bangkok, Thailand, 10400

Actively Recruiting

77

Siriraj Hospital

Bangkok, Thailand, 10700

Actively Recruiting

78

Songklanagarind Hospital (Prince of Songkhla University)

Hat Yai, Thailand, 90110

Actively Recruiting

79

Srinagarind Hospital (Khon Kaen University)

Muang, Thailand, 40002

Actively Recruiting

80

Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)

Muang, Thailand, 50200

Actively Recruiting

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Research Team

S

Study Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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