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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06598800




Registration number
NCT06598800
Ethics application status
Date submitted
12/09/2024
Date registered
19/09/2024

Titles & IDs
Public title
Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors
Scientific title
A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-T187, an EGFR×MET Trispecific Antibody, Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
2024-514944-10-00
Secondary ID [2] 0 0
BG-T187-101
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 - Drug: BG-T187

Experimental: Phase 1a: Part A: Monotherapy Dose Escalation - Sequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy.

Experimental: Phase 1a: Part B: Monotherapy Safety Expansion - BG-T187 dose levels that have been determined to be safe and tolerable in Part A will be investigated.

Experimental: Phase 1b: Monotherapy Dose Expansion - The monotherapy dose expansion phase will begin once the BG-T187 monotherapy recommended dose for expansion (RDFE) and dosing schedule have been determined from Parts A and B in Phase 1a.


Treatment: Drugs: Drug: BG-T187
Intravenous administration
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 (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Approximately 2 years
Primary outcome [2] 0 0
Phase 1a: Maximum Administered Dose (MAD) of BG-T187
Timepoint [2] 0 0
Approximately 2 years
Primary outcome [3] 0 0
Phase 1a: Maximum Tolerated Dose (MTD) of BG-T187
Timepoint [3] 0 0
Approximately 2 years
Primary outcome [4] 0 0
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-T187
Timepoint [4] 0 0
Approximately 2 years
Primary outcome [5] 0 0
Phase 1b: Overall Response Rate (ORR)
Timepoint [5] 0 0
Approximately 2 years
Primary outcome [6] 0 0
Phase 1b: Recommended Phase 2 dose (RP2D) of BG-T187 alone and in combination with other therapeutic agents
Timepoint [6] 0 0
Approximately 2 years
Secondary outcome [1] 0 0
Phase 1a: ORR
Timepoint [1] 0 0
Approximately 2 years
Secondary outcome [2] 0 0
Phase 1a and 1b: Duration of Response (DOR)
Timepoint [2] 0 0
Approximately 2 years
Secondary outcome [3] 0 0
Phase 1a and 1b: Disease Control Rate (DCR)
Timepoint [3] 0 0
Approximately 2 years
Secondary outcome [4] 0 0
Phase 1b: Progression Free Survival (PFS)
Timepoint [4] 0 0
Approximately 2 years
Secondary outcome [5] 0 0
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-T187
Timepoint [5] 0 0
From Cycle 1 Day 1 up to Cycle19 Day1 (each cycle is 28 days)
Secondary outcome [6] 0 0
Phase 1a and 1b: Area Under the Plasma Concentration-time Curve (AUC) of BG-T187
Timepoint [6] 0 0
From Cycle 1 Day 1 up to Cycle19 Day1 (each cycle is 28 days)
Secondary outcome [7] 0 0
Phase 1a and 1b: Terminal Half-Life (t1/2) of BG-T187
Timepoint [7] 0 0
From Cycle 1 Day 1 up to Cycle19 Day1 (each cycle is 28 days)
Secondary outcome [8] 0 0
Phase 1a and 1b: Time to maximum plasma concentration (Tmax) of BG-T187
Timepoint [8] 0 0
From Cycle 1 Day 1 up to Cycle19 Day1 (each cycle is 28 days)
Secondary outcome [9] 0 0
Phase 1a and 1b: Number of participants with anti-drug antibodies (ADAs) to BG-T187
Timepoint [9] 0 0
From Cycle 1 Day 1 up to Cycle19 Day1 (each cycle is 28 days)
Secondary outcome [10] 0 0
Phase 1b: Number of Participants with AEs and SAEs
Timepoint [10] 0 0
Approximately 2 years

Eligibility
Key inclusion criteria
1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
2. Patients must be = 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status = 1.
4. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated.
5. = 1 measurable or nonmeasurable lesion as assessed by RECIST v1.1. for Phase 1a Part A; = 1 measurable lesion per RECIST v1.1. for Phase 1a Part B and Phase 1b.
6. Adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior severe allergic reactions or hypersensitivity to the active ingredient and excipients of BG-T187 or other monoclonal antibodies.
2. Spinal cord compression, active leptomeningeal disease, or uncontrolled, untreated brain metastasis.
3. Any malignancy = 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
4. History of ILD or noninfectious pneumonitis requiring steroids or other immune suppressive agents = 2 years before the first dose of the study drug, or with current ILD/noninfectious pneumonitis, or where suspected ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening.
5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence =14 days after intervention).
6. Active hepatitis C.
7. Infection (including tuberculosis infection, or other) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy = 14 days before the first dose of study drug(s).

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
18/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2028
Actual
Sample size
Target
87
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
6009 - Nedlands

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/NCT06598800