Recruiting
Phase 1

BGB-58067

Sponsor:

BeOne Medicines

Code:

NCT06589596

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BGB-58067

BG-89894

Standard of Care Therapy

Study Details

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

Conditions

Advanced Solid Tumor

Study ID

NCT06589596

Start date

Jan 10, 2025

Status verified date

Jul, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

525 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

BGB-58067

Planned doses administered on specified days per protocol.

BG-89894

Planned doses administered on specified days per protocol.

Standard of Care Therapy

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

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) ]
  • Phase 1a: Number of Participants with Adverse Events that meet Dose-Limiting Toxicity (DLT) criteria [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Approximately 13 months ]
  • Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-58067 alone and in combination with standard of care therapy [ Time Frame: Approximately 2 years ]
  • Phase 1b: Objective Response Rate (ORR) [ Time Frame: Approximately 2 years ]

Central Contacts and Locations

Central contacts

Study Director

1.877.828.5568clinicaltrials@beonemed.com

Locations

Usc Norris Comprehensive Cancer Center (Nccc)

Recruiting

Los Angeles, California, United States, 90089-1019

Adventhealth

Recruiting

Celebration, Florida, United States, 34747-4606

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215-5418

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110-1010

Nyu Langone Health

Recruiting

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

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Sidney Kimmel Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107-4307

Tennessee Oncology, Pllc Nashville

Recruiting

Nashville, Tennessee, United States, 37203

The University of Texas Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-4009

Next Dallas

Recruiting

Irving, Texas, United States, 75039-2743

Next Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

BeOne Medicines

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • advanced solid tumor
  • BGB-58067
  • MTAP deficiency

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-07-22.