This is a first-in-human, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors. Study details include: * The study will be conducted in 2 phases: Phase 1a (Monotherapy Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion). * The visit frequency will be approximately every 21 days during study treatment. Maximum treatment duration will be up to two years. * The study duration is estimated to be approximately 5 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Administered by intravenous infusion
Administered by intravenous infusion
Florida Cancer Specialist Research Institute Lake Nona
Orlando, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Next Oncology
Austin, Texas, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Westmead Hospital
Westmead, New South Wales, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
One Clinical Research
Nedlands, Western Australia, Australia
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
...and 4 more locations
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0\]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed; and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time frame: Approximately 24 months
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-C354
Defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% or the highest dose administered, respectively
Time frame: Approximately 1 month
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-C354
The potential RDFE(s) of BGB-C354 will be determined based on the MTD or MAD, taking into consideration the long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available
Time frame: Approximately 24 months
Phase 1b: Overall Response Rate (ORR)
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Time frame: Approximately 24 months
Phase 1b: Recommended Phase 2 dose (RP2D) of BGB-C354 alone and in combination with tislelizumab
The RP2D of BGB-C354 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.
Time frame: Approximately 24 months
Phase 1a: ORR
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.
Time frame: Approximately 24 months
Duration of Response (DOR)
DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.
Time frame: Approximately 24 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease as determined from tumor assessments by the investigator using RECIST v1.1.
Time frame: Approximately 24 months
Phase 1b: Progression Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first as determined from tumor assessments by the investigator using RECIST v1.1.
Time frame: Approximately 24 months
Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events
Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0\]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed; and adverse events meeting protocol-defined dose-limitingtoxicity (DLT) criteria
Time frame: Approximately 24 months
Maximum observed plasma concentration (Cmax) for BGB-C354
Time frame: Twice in the first 3 months
Minimum observed plasma concentration (Cmin) for BGB-C354
Time frame: Approximately 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time to maximum plasma concentration (Tmax) for BGB-C354
Time frame: Twice in the first 3 months
Half-life (t1/2) for BGB-C354
Time frame: Twice in the first 3 months
Area under the concentration-time curve (AUC) for BGB-C354
Time frame: Twice in the first 3 months
Apparent clearance (CL/F) for BGB-C354
Time frame: Approximately 12 months
Apparent volume of distribution (Vz/F) for BGB-C354
Time frame: Approximately 12 months
Accumulation ratio for BGB-C354
Time frame: Approximately 12 months
Number of participants with anti-drug antibodies (ADAs) to BGB-C354
Time frame: Approximately 12 months
Serum concentration of BGB-C354
Time frame: Approximately 12 months