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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06233942




Registration number
NCT06233942
Ethics application status
Date submitted
23/01/2024
Date registered
31/01/2024
Date last updated
6/06/2024

Titles & IDs
Public title
Study of BG-C9074 as Monotherapy and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
Scientific title
Phase 1a/1b Study of BG-C9074, an Antibody Drug Conjugate Targeting B7H4, as Monotherapy and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
Secondary ID [1] 0 0
2023-509958-65-00
Secondary ID [2] 0 0
BG-C9074-101
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-C9074
Treatment: Drugs - Tislelizumab

Experimental: Phase 1a: Part A (Monotherapy Dose Escalation) - BG-C9074 monotherapy dose escalation

Experimental: Phase 1a: Part B (Monotherapy Safety Expansion) - BG-C9074 dose levels that have been determined to be safe and tolerable in Part A will be investigated.

Experimental: Phase 1a: Part C (Combination Therapy Dose Escalation) - BG-C9074 plus tislelizumab combination at the recommended dose for expansion (RDFE).

Experimental: Phase 1b: Monotherapy Dose Expansion - The monotherapy dose expansion phase will begin once the BG-C9074 monotherapy RDFE and dosing schedule have been determined from Parts A and B in Phase 1a.


Treatment: Drugs: BG-C9074
administered by intravenous infusion

Treatment: Drugs: Tislelizumab
administered by intravenous infusion
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 3 years
Primary outcome [2] 0 0
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C9074
Timepoint [2] 0 0
Approximately 18 months
Primary outcome [3] 0 0
Phase 1a: Recommended Dose for Expansion (RDFE) of BG-C9074.
Timepoint [3] 0 0
Approximately 18 months
Primary outcome [4] 0 0
Phase 1b: Overall Response Rate (ORR)
Timepoint [4] 0 0
Approximately 3 years
Primary outcome [5] 0 0
Phase 1b: Recommended Phase 2 dose (RP2D) of BG-C9074
Timepoint [5] 0 0
Approximately 30 months
Secondary outcome [1] 0 0
Phase 1a: ORR
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
Approximately 3 years
Secondary outcome [4] 0 0
Clinical Benefit Rate (CBR)
Timepoint [4] 0 0
Approximately 3 years
Secondary outcome [5] 0 0
Phase 1b: Progression Free Survival (PFS)
Timepoint [5] 0 0
Approximately 3 years
Secondary outcome [6] 0 0
Phase 1b: Number of Participants with AEs and SAEs
Timepoint [6] 0 0
Approximately 3 years
Secondary outcome [7] 0 0
Maximum observed plasma concentration (Cmax) for BG-C9074
Timepoint [7] 0 0
Approximately 3 years
Secondary outcome [8] 0 0
Minimum observed plasma concentration (Cmin) for BG-C9074
Timepoint [8] 0 0
Approximately 3 years
Secondary outcome [9] 0 0
Time to maximum plasma concentration (Tmax) for BG-C9074
Timepoint [9] 0 0
Approximately 3 years
Secondary outcome [10] 0 0
Half-life (t1/2) for BG-C9074
Timepoint [10] 0 0
Approximately 3 years
Secondary outcome [11] 0 0
Area under the concentration-time curve (AUC) for BG-C9074
Timepoint [11] 0 0
Approximately 3 years
Secondary outcome [12] 0 0
Apparent clearance (CL/F) for BG-C9074
Timepoint [12] 0 0
Approximately 3 years
Secondary outcome [13] 0 0
Apparent volume of distribution (Vz/F) for BG-C9074
Timepoint [13] 0 0
Approximately 3 years
Secondary outcome [14] 0 0
Accumulation ratio for BG-C9074
Timepoint [14] 0 0
Approximately 3 years
Secondary outcome [15] 0 0
Plasma concentrations for BG-C9074
Timepoint [15] 0 0
Approximately 3 years
Secondary outcome [16] 0 0
Number of participants with anti-drug antibodies (ADAs) to BG-C9074
Timepoint [16] 0 0
Approximately 3 years
Secondary outcome [17] 0 0
Serum concentration of BG-C0974
Timepoint [17] 0 0
Approximately 3 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. Eastern Cooperative Oncology Group (ECOG) Performance Status = 1.

3. Participants with selected histologically or cytologically confirmed advanced,
metastatic, and unresectable solid tumors who have been previously treated.

4. = 1 measurable lesion per RECIST v1.1.

5. Able to provide an archived tumor tissue sample.

6. Adequate organ function.

7. Females of childbearing potential must be willing to use a highly effective method of
birth control for the duration of the study, and for = 7 months after the last dose of
study drug(s).

8. Nonsterile males must be willing to use a highly effective method of birth control for
the duration of the study treatment period and for = 4 months after the last dose of
study drug(s).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior treatment with a B7H4-targeting antibody drug conjugates (ADC)

2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis

3. Any malignancy = 2 years before the first dose of study treatment(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 interstitial lung disease, = Grade 2 noninfectious pneumonitis, oxygen
saturation at rest < 92%, or requirement for supplemental oxygen at baseline

5. Uncontrolled diabetes.

6. Infection (including tuberculosis infection) requiring systemic (oral or intravenous)
antibacterial, antifungal, or antiviral therapy = 14 days before the first dose of
study treatment(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
Parallel
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
12/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/09/2027
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Macquarie University - North Ryde
Recruitment hospital [2] 0 0
Cancer Care Wollongong - Wollongong
Recruitment hospital [3] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2109 - North Ryde
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a first-in-human, dose finding and dose expansion study to evaluate the safety,
tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of
BG-C9074 alone and in combination with tislelizumab in participants with advanced solid
tumors. Participants will receive study drug(s) until progressive disease, unacceptable
toxicity, withdrawal of consent, death, or another discontinuation criterion is met,
whichever occurs first. The maximum length of receiving study drug(s) for a participant is up
to 2 years.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06233942
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06233942