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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06596473




Registration number
NCT06596473
Ethics application status
Date submitted
11/09/2024
Date registered
19/09/2024

Titles & IDs
Public title
A Study of BG-C477 in Participants With Advanced Solid Tumors
Scientific title
A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C477 in Patients With Selected Advanced Solid Tumors
Secondary ID [1] 0 0
BG-C477-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BG-C477
Treatment: Drugs - Chemotherapy

Experimental: Phase 1a: BG-C477 Monotherapy Dose Escalation - Sequential cohorts of increasing dose levels of BG-C477 will be evaluated as monotherapy.

Experimental: Phase 1a: BG-C477 Monotherapy Safety Expansion - Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in monotherapy.

Experimental: Phase 1b Part A: BG-C477 Monotherapy Dose Optimization - Participants with selected advanced solid tumors will be evaluated at different dose levels of RDFEs identified in Phase 1a.

Experimental: Phase 1b Part B: Combination Therapy Expansion - Sequential cohorts of increasing dose levels of BG-C477 will be evaluated in combination with capecitabine with or without bevacizumab.


Treatment: Drugs: BG-C477
Administered intravenously.

Treatment: Drugs: Chemotherapy
Administered in accordance with relevant local guidelines and/or prescribing information.
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
From first dose of the study drug(s) to 30 days after the last dose (up to 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 year
Primary outcome [3] 0 0
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C477
Timepoint [3] 0 0
Approximately 1 year
Primary outcome [4] 0 0
Phase 1b: Objective Response Rate (ORR)
Timepoint [4] 0 0
Approximately 2 years
Primary outcome [5] 0 0
Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C477
Timepoint [5] 0 0
Approximately 2 years
Secondary outcome [1] 0 0
Phase 1a: ORR
Timepoint [1] 0 0
Approximately 1 year
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 1b: Number of Participants with AEs and SAEs
Timepoint [5] 0 0
From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)
Secondary outcome [6] 0 0
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-C477 antibody-drug conjugate (ADC), BG-C477 total antibody, and free payload
Timepoint [6] 0 0
Approximately 2 years
Secondary outcome [7] 0 0
Phase 1a and 1b: Minimum concentration (Cmin) of BG-C477
Timepoint [7] 0 0
Approximately 2 years
Secondary outcome [8] 0 0
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-C477
Timepoint [8] 0 0
Approximately 2 years
Secondary outcome [9] 0 0
Phase 1a and 1b: Area under the concentration-versus-time curve during dosing interval (AUCtau) of BG-C477
Timepoint [9] 0 0
Approximately 2 years
Secondary outcome [10] 0 0
Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-C477
Timepoint [10] 0 0
Approximately 2 years
Secondary outcome [11] 0 0
Phase 1a and 1b: Systemic clearance (CL/F) of BG-C477
Timepoint [11] 0 0
Approximately 2 years
Secondary outcome [12] 0 0
Phase 1a and 1b: Apparent volume of distribution at steady state (Vss) of BG-C477
Timepoint [12] 0 0
Approximately 2 years
Secondary outcome [13] 0 0
Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs) against BG-C477
Timepoint [13] 0 0
Approximately 2 years

Eligibility
Key inclusion criteria
* Participants must sign the informed consent form (ICF) and be capable of giving written informed consent
* Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy
* Phase 1a (Dose Escalation); Histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, who were previously treated with at least 2 lines of standard systemic therapy or for whom no standard treatment is available in the medical judgment of the investigator
* = 1 measurable lesion as assessed by RECIST v1.1
* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of = 1
* Adequate organ function
* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for = 8 months after the last dose of BG-C477 and for = 6 months after the last dose of chemotherapy, whichever comes later
* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for = 5 months after the last dose of BG-C477, and for = 3 months after chemotherapy, whichever comes later.
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 carcinoembryonic antigen (CEA)-targeted ADCs or ADCs containing topoisomerase 1 (TOP1) inhibitor as payload
* History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics
* Active leptomeningeal disease or uncontrolled, untreated brain metastasis
* Any malignancy = 2 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 curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)

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
3/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/10/2028
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Cancer Research South Australia - Adelaide
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

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/NCT06596473