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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06589596




Registration number
NCT06589596
Ethics application status
Date submitted
6/09/2024
Date registered
19/09/2024

Titles & IDs
Public title
An Investigational Study of BGB-58067 in Participants With Advanced Solid Tumors
Scientific title
A Phase 1a/b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-58067, an MTA-Cooperative PRMT5 Inhibitor in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
2024-515307-19-00
Secondary ID [2] 0 0
BGB-58067-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-58067

Experimental: Phase 1a: Dose Escalation and Safety Expansion - Sequential cohorts of increasing dose levels of BGB-58067 as monotherapy will be evaluated.

Experimental: Phase 1b: Dose Expansion and Optimization - Recommended Dose(s) for Expansion (RDFE\[s\]) of BGB-58067 as monotherapy will be evaluated for selected indications based on emerging data.


Treatment: Drugs: BGB-58067
Planned doses administered on specified days per protocol.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1a: Number of Participants with Adverse Events and Serious Adverse Events
Timepoint [1] 0 0
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)
Primary outcome [2] 0 0
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
Timepoint [2] 0 0
Approximately 1.5 years
Primary outcome [3] 0 0
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BGB-58067
Timepoint [3] 0 0
Approximately 2 years
Primary outcome [4] 0 0
Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-58067
Timepoint [4] 0 0
Approximately 2 years
Primary outcome [5] 0 0
Phase 1b: Objective Response Rate (ORR)
Timepoint [5] 0 0
Approximately 2 years
Secondary outcome [1] 0 0
Phase 1a: Objective Response Rate (ORR)
Timepoint [1] 0 0
Approximately 2 years
Secondary outcome [2] 0 0
Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-58067
Timepoint [2] 0 0
Approximately 2 years
Secondary outcome [3] 0 0
Phase 1a: Minimum observed plasma concentration (Cmin) of BGB-58067
Timepoint [3] 0 0
Approximately 2 years
Secondary outcome [4] 0 0
Phase 1a: Time to reach maximum observed plasma concentration (Tmax) of BGB-58067
Timepoint [4] 0 0
Approximately 2 years
Secondary outcome [5] 0 0
Phase 1a: Apparent oral clearance (CL/F) for BGB-58067
Timepoint [5] 0 0
Approximately 2 years
Secondary outcome [6] 0 0
Phase 1a: Half life (t1/2) of BGB-58067
Timepoint [6] 0 0
Approximately 2 years
Secondary outcome [7] 0 0
Phase 1a: Area under the concentration-time curve (AUC) of BGB-58067
Timepoint [7] 0 0
Approximately 2 years
Secondary outcome [8] 0 0
Phase 1a: Apparent volume of distribution (Vz/F) for BGB-58067
Timepoint [8] 0 0
Approximately 2 years
Secondary outcome [9] 0 0
Phase 1a: Accumulation ratio (AR) for BGB-58067
Timepoint [9] 0 0
Approximately 2 years
Secondary outcome [10] 0 0
Phase 1a and 1b: plasma concentrations of BGB-58067
Timepoint [10] 0 0
Approximately 2 years
Secondary outcome [11] 0 0
Phase 1a and 1b: Duration of Response (DOR)
Timepoint [11] 0 0
Approximately 2 years
Secondary outcome [12] 0 0
Phase 1a and 1b: Disease Control Rate (DCR)
Timepoint [12] 0 0
Approximately 2 years
Secondary outcome [13] 0 0
Phase 1b: Number of Participants with AEs and SAEs
Timepoint [13] 0 0
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)
Secondary outcome [14] 0 0
Phase 1b: Progression-Free Survival (PFS)
Timepoint [14] 0 0
Approximately 2 years

Eligibility
Key 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 advanced, metastatic, or unresectable solid tumors, who have previously received standard systemic therapy or for whom treatment is not available or not tolerated
* Adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with any 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
* High cardiovascular risk factors
* QTcF > 470 ms based on the screening triplicate 12-lead ECG records
* 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Austin Health - Heidelberg
Recruitment hospital [4] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
China
State/province [7] 0 0
Beijing
Country [8] 0 0
China
State/province [8] 0 0
Fujian
Country [9] 0 0
China
State/province [9] 0 0
Guangdong
Country [10] 0 0
China
State/province [10] 0 0
Heilongjiang
Country [11] 0 0
China
State/province [11] 0 0
Henan
Country [12] 0 0
China
State/province [12] 0 0
Shanghai
Country [13] 0 0
France
State/province [13] 0 0
Bordeaux
Country [14] 0 0
France
State/province [14] 0 0
Marseille
Country [15] 0 0
France
State/province [15] 0 0
Paris
Country [16] 0 0
France
State/province [16] 0 0
Villejuif
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul Teugbyeolsi
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
1.877.828.5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.beigenemedical.com/medical-information-request


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06589596