A Phase 1 interventional study of BGB-58067 and BG-89894 in Advanced Solid Tumor, sponsored by BeOne Medicines. Recruiting at 101 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by BeOne Medicines · Phase 1, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sequential cohorts of increasing dose levels of BGB-58067 as monotherapy will be evaluated.
Drug: BGB-58067
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 · Drug: BG-89894
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
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 · Drug: Standard of Care Therapy
Planned doses administered on specified days per protocol.
Planned doses administered on specified days per protocol.
Administered in accordance with relevant local guidelines and/or prescribing information.
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 2 years
Phase 1a: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with confirmed CR or PR, as assessed by the investigator.
Time frame: Approximately 2 years
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BGB-58067
Time frame: Approximately 2 months
Phase 1a and 1b: Minimum observed plasma concentration (Cmin) of BGB-58067
Time frame: Approximately 9 months
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BGB-58067
Time frame: Approximately 2 months
Phase 1a and 1b: Apparent oral clearance (CL/F) for BGB-58067
Time frame: Approximately 2 months
Phase 1a and 1b: Half-life (t1/2) of BGB-58067
Time frame: Approximately 2 months
Phase 1a and 1b: Area under the concentration-time curve (AUC) of BGB-58067
Time frame: Approximately 2 months
Phase 1a and 1b: Apparent volume of distribution (Vz/F) for BGB-58067
Time frame: Approximately 2 months
Phase 1a and 1b: Accumulation ratio (AR) for BGB-58067
Time frame: Approximately 2 months
Phase 1a and 1b: Plasma concentrations of BGB-58067
Time frame: Approximately 9 months
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.
Time frame: 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.
Time frame: Approximately 2 years
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.
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 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.
Time frame: Approximately 2 years
Showing the first 100 of 101 sites across 11 countries.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Csr
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