Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06625593




Registration number
NCT06625593
Ethics application status
Date submitted
23/09/2024
Date registered
3/10/2024

Titles & IDs
Public title
A First-in-Human Study of BG-C137, an Anti-FGFR2b Antibody Drug Conjugate, in Participants With Advanced Solid Tumors
Scientific title
A Phase 1a/b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C137, an Antibody-Drug Conjugate Targeting FGFR2b, in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
BG-C137-101
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 - BG-C137

Experimental: Phase 1a: Dose Escalation and Safety Expansion - Sequential cohorts of increasing dose levels of BG-C137 will be evaluated as monotherapy

Experimental: Phase 1b: Dose Expansion - Recommended Dose(s) of BG-C137 as determined from Ph1a will be evaluated in select indications


Treatment: Drugs: BG-C137
Administered intravenously
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
Up to approximately 2 years
Primary outcome [2] 0 0
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C137
Timepoint [2] 0 0
Up to approximately 2 years
Primary outcome [3] 0 0
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C137
Timepoint [3] 0 0
Up to approximately 2 years
Primary outcome [4] 0 0
Phase 1b: The recommended Phase 2 dose (RP2D) of BG-C137
Timepoint [4] 0 0
Up to approximately 2 years
Primary outcome [5] 0 0
Phase 1b: Overall Response Rate (ORR)
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Phase 1a: ORR
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Phase 1a and 1b: Disease Control Rate (DCR)
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
Phase 1a and 1b: Duration of Response (DOR)
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Phase 1b: Progression Free Survival (PFS)
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [5] 0 0
Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Phase 1a: Plasma concentrations of BG-C137 analytes
Timepoint [6] 0 0
Up to approximately 1 year; at the end of treatment (maximum of 2 years) and at the first safety follow-up visit (30 days after last dose)
Secondary outcome [7] 0 0
Phase 1b: Plasma concentrations of BGB-C137 analytes
Timepoint [7] 0 0
Up to approximately 1 year; at the end of treatment (maximum of 2 years) and at the first safety follow-up visit (30 days after last dose)
Secondary outcome [8] 0 0
Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-C137 analytes
Timepoint [8] 0 0
Twice in the first 3 months
Secondary outcome [9] 0 0
Phase 1a: Time to reach maximum observed plasma concentration (Tmax) of BGB-C137 analytes
Timepoint [9] 0 0
Twice in the first 3 months
Secondary outcome [10] 0 0
Phase 1a: Minimum Observed Plasma Concentration (Ctrough) Of BGB-C137 analytes
Timepoint [10] 0 0
Twice in the first 3 months
Secondary outcome [11] 0 0
Phase 1a: Area Under the Plasma Concentration-time Curve (AUC) of BGB-C137 analytes
Timepoint [11] 0 0
Twice in the first 3 months
Secondary outcome [12] 0 0
Phase 1a: Terminal Half-Life (t1/2) of BGB-C137 analytes
Timepoint [12] 0 0
Twice in the first 3 months
Secondary outcome [13] 0 0
Phase 1a and 1b: Incidence of Antidrug Antibodies (ADAs) to BGB-C137
Timepoint [13] 0 0
Up to approximately 2 years

Eligibility
Key inclusion criteria
1. Histologically or cytologically confirmed advanced or metastatic solid tumors.
2. Life expectancy of = 3 months.
3. Prior standard systemic therapy in the advanced or metastatic setting. Dose Escalation: Participants for whom further standard treatment is not available, not tolerated or determined not appropriate based on the investigator's judgment. Safety Expansion and Dose Expansion: Participants who have received 1 or 2 prior lines of systemic therapy in the advanced or metastatic setting.
4. Participants must provide agreement for collection of archival tissue or recently obtained fresh tumor biopsy for central evaluation of FGFR2b expression levels and other biomarker assessments.
5. = 1 measurable lesion per RECIST v1.1.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
7. Adequate organ function as determined per protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies.
2. Active or chronic corneal disorder, history of corneal transplantation, corneal keratitis, keratoconjuntivitis, keratopathy, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
3. Spinal cord compression, or active leptomeningeal disease or uncontrolled, untreated brain metastasis.
4. Systemic antitumor therapy (including targeted therapy and immunotherapy = 14 days, = 28 days for immuno- oncological antibody, = 14 days or 5 half-lives [whichever is shorter] for chemotherapy, ADCs, or investigational therapy) before first dose of study drug(s).
5. Toxicities due to prior therapy that have not recovered.
6. Any malignancy = 2 years before 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 curatively.
7. History of interstitial lung disease (ILD), noninfectious pneumonitis, oxygen saturation at rest < 92%, or requirement for supplemental oxygen at baseline.

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
9/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Icon Cancer Centre South Brisbane - South Brisbane
Recruitment hospital [4] 0 0
Monash Health - Clayton
Recruitment hospital [5] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3144 - Malvern
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
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
China
State/province [6] 0 0
Beijing
Country [7] 0 0
China
State/province [7] 0 0
Hubei
Country [8] 0 0
China
State/province [8] 0 0
Shanghai

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/NCT06625593