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An Investigational Study of BGB-58067 in Participants With Advanced Solid Tumors
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 as monotherapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.
Study details:
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 as monotherapy in participants with advanced solid tumors and with MTAP deficiency.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-10-11
Primary completion: 2026-11-01
Study completion finish: 2026-11-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06589596
Intervention or treatment
DRUG: BGB-58067
Conditions
- • Advanced Solid Tumor
Find a site
Closest Location:
Linear Clinical Research
Research sites nearby
Select from list below to view details:
Linear Clinical Research
Nedlands, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Phase 1a: Dose Escalation and Safety Expansion
| DRUG: BGB-58067
|
EXPERIMENTAL: Phase 1b: Dose Expansion and Optimization
| DRUG: BGB-58067
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| 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, and that meet protocol-defined dose-limiting toxicity (DLT) criteria. | 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 2 years) |
| Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) | 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 1.5 years |
| Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BGB-58067 | RDFE of BGB-58067 will be determined based upon the MTD or MAD. | Approximately 2 years |
| Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-58067 | RP2D established from Phase 1a for BGB-58067 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 outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Phase 1a: Objective Response Rate (ORR) | ORR is defined as the percentage of participants with confirmed CR or PR, as assessed by the investigator. | Approximately 2 years |
| Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-58067 | Not Specified | Approximately 2 years |
| Phase 1a: Minimum observed plasma concentration (Cmin) of BGB-58067 | Not Specified | Approximately 2 years |
| Phase 1a: Time to reach maximum observed plasma concentration (Tmax) of BGB-58067 | Not Specified | Approximately 2 years |
| Phase 1a: Apparent oral clearance (CL/F) for BGB-58067 | Not Specified | Approximately 2 years |
| Phase 1a: Half life (t1/2) of BGB-58067 | Not Specified | Approximately 2 years |
| Phase 1a: Area under the concentration-time curve (AUC) of BGB-58067 | Not Specified | Approximately 2 years |
| Phase 1a: Apparent volume of distribution (Vz/F) for BGB-58067 | Not Specified | Approximately 2 years |
| Phase 1a: Accumulation ratio (AR) for BGB-58067 | Not Specified | Approximately 2 years |
| Phase 1a and 1b: plasma concentrations of BGB-58067 | Not Specified | Approximately 2 years |
| 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. | 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. | 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. | 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 2 years) |
| 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. | Approximately 2 years |
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