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

NCT06589596 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: BGB-58067-1012024-515307-19-00CTR20244451
• Study Type: interventional
• Target: 244
• Locations: 7 countries
• Sites: 62

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

Conditions

Advanced Solid Tumor

Keywords

advanced solid tumor; BGB-58067; MTAP deficiency; BG-89894

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  Approximately 13 months

• Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy

  RP2D established from Phase 1a for BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy for administration in selected tumor types.

  Approximately 2 years

• 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

Secondary Outcomes (14)

• Phase 1a: Objective Response Rate (ORR)

  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

Study Arms (4)

Phase 1a: BGB-58067 Monotherapy Dose Escalation and Safety Expansion

EXPERIMENTAL

Sequential cohorts of increasing dose levels of BGB-58067 as monotherapy will be evaluated.

Drug: BGB-58067

Phase 1a: BGB-58067 + BG-89894 Combination Therapy Dose Escalation

EXPERIMENTAL

Sequential cohorts of increasing dose levels of BGB-58067 in combination with BGB-89894 will be evaluated.

Drug: BGB-58067; Drug: BG-89894

Phase 1a: BGB-58067 + Standard of Care Combination Therapy Dose Escalation

EXPERIMENTAL

Sequential cohorts of increasing dose levels of BGB-58067 in combination with standard of care therapy will be evaluated.

Drug: BGB-58067; Drug: Standard of Care Therapy

Phase 1b: Dose Expansion and Optimization

EXPERIMENTAL

Recommended Dose(s) for Expansion (RDFE\[s\]) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy will be evaluated for selected indications and regimen(s) based on emerging data.

Drug: BGB-58067; Drug: BG-89894; Drug: Standard of Care Therapy

Interventions

BGB-58067 DRUG

Planned doses administered on specified days per protocol.

Phase 1a: BGB-58067 + BG-89894 Combination Therapy Dose Escalation; Phase 1a: BGB-58067 + Standard of Care Combination Therapy Dose Escalation; Phase 1a: BGB-58067 Monotherapy Dose Escalation and Safety Expansion; Phase 1b: Dose Expansion and Optimization

BG-89894 DRUG

Planned doses administered on specified days per protocol.

Phase 1a: BGB-58067 + BG-89894 Combination Therapy Dose Escalation; Phase 1b: Dose Expansion and Optimization

Standard of Care Therapy DRUG

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

Phase 1a: BGB-58067 + Standard of Care Combination Therapy Dose Escalation; Phase 1b: Dose Expansion and Optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (62)

Usc Norris Comprehensive Cancer Center (Nccc)

Los Angeles, California, 90089-1019, United States

RECRUITING

Adventhealth

Celebration, Florida, 34747-4606, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215-5418, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110-1010, United States

RECRUITING

Nyu Langone Health

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

RECRUITING

Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107-4307, United States

RECRUITING

The University of Texas Md Anderson Cancer Center

Houston, Texas, 77030-4009, United States

RECRUITING

Next Dallas

Irving, Texas, 75039-2743, United States

RECRUITING

Next Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, NSW 2148, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, QLD 4102, Australia

RECRUITING

Monash Health

Clayton, Victoria, VIC 3168, Australia

RECRUITING

Austin Health

Heidelberg, Victoria, VIC 3084, Australia

RECRUITING

Linear Clinical Research

Nedlands, Western Australia, WA 6009, Australia

RECRUITING

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, 101149, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510405, China

RECRUITING

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi, 530201, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

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

Wuhan, Hubei, 430022, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

Yichang Central Peoples Hospital

Yichang, Hubei, 443003, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

The Second Affiliated Hospital of Shandong First Medical University

Taian, Shandong, 271099, China

RECRUITING

Weifang Peoples Hospital Beichen Branch

Weifang, Shandong, 261057, China

RECRUITING

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai East Hospital Branch Hospital

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Fudan University Shanghai Cancer Centerpudong

Shanghai, Shanghai Municipality, 201321, China

RECRUITING

Sichuan Cancer Hospitaltianfu Branch

Chengdu, Sichuan, 610000, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Deyangs People Hospital

Deyang, Sichuan, 618000, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Zhejiang Provincial Peoples Hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Taizhou Hospital of Zhejiang

Taizhou, Zhejiang, 317000, China

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, 33000, France

RECRUITING

Institut Curie Paris

Paris, 75005, France

RECRUITING

Institut de Cancerologie de Louest

Saint-Herblain, 44800, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94800, France

RECRUITING

Seoul National University Bundang Hospital

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

RECRUITING

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

RECRUITING

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 03080, South Korea

RECRUITING

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

RECRUITING

Hospital Universitario Vall Dhebron

Barcelona, 08035, Spain

RECRUITING

Start Madrid Fundacion Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Hm Madrid Sanchinarro

Madrid, 28050, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, 28240, Spain

RECRUITING

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1.877.828.5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: October 11, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

KR (5); CN (34); DK (1); US (9); AU (5); ES (4); FR (4)