This study is a first-in-human (FIH), Phase 1a/1b study of BG-C0902, a fully humanized anti-epidermal growth factor receptor (EGFR) and anti-mesenchymal-epithelial transition (MET) antibody, conjugated via an enzymatically cleavable linker to a topoisomerase 1 (TOPO1) inhibitor payload. The study aims to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C0902 in participants with advanced solid tumors. The study will be conducted in 2 phases: Phase 1a (dose escalation and safety expansion) and Phase 1b (dose expansion).
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Administered by intravenous infusion
Next Oncology
Austin, Texas, United States
RECRUITINGThe University of Texas Md Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNext Virginia
Fairfax, Virginia, United States
RECRUITINGBlacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
RECRUITINGMonash Health
Clayton, Victoria, Australia
RECRUITINGThe Alfred Hospital
Melbourne, Victoria, Australia
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGPhase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Approximately 24 Months
Phase 1a: Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Approximately 21 Days
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0902
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
Time frame: Approximately 24 Months
Phase 1a: Recommended dose(s) for Expansion (RDFE) of BG-C0902
RDFE of BG-C0902 will be determined based upon the MTD or MAD.
Time frame: Approximately 24 Months
Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C0902 as Monotherapy
RP2D as determined based on safety, pharmacokinetics (PK), pharmacodynamics, preliminary antitumor activity, and 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 of complete response (CR) or partial response (PR) as determined from tumor assessments by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Approximately 24 Months
Phase 1a: ORR
ORR is defined as the percentage of participants with best overall response of CR or PR. as assessed by the investigator using RECIST v1.1.
Time frame: Approximately 24 Months
Phase 1a and 1b: Duration of Response (DOR)
DOR is defined as the time from the first confirmed objective response by the investigator using RECIST v1.1 until the first documentation of disease progression after treatment initiation or death, whichever comes first.
Time frame: Approximately 24 Months
Phase 1a and 1b: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with the best overall response, of a CR, PR, and stable disease assessed 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 first dose until first documentation of progression or death, whichever comes first, as assessed 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 (SAEs)
Number of participants with treatment-emergent AEs and SAEs.
Time frame: Approximately 24 Months
Phase 1a and 1b: Area under the Concentration-time Curve (AUC) of BG-C0902, Total Antibody, and Payload
Time frame: Two times in the first three months
Phase 1a and 1b: Maximum Observed Plasma Concentration (Cmax) of BG-C0902, Total Antibody, and Payload
Time frame: Two times in the first three months
Phase 1a and 1b: Time to Maximum Concentration (Tmax) of BG-C0902, Total Antibody, and Payload
Time frame: Two times in the first three months
Phase 1a and 1b: Half-life (t1/2) of BG-C0902, Total Antibody, and Payload
Time frame: Two times in the first three months
Phase 1a and 1b: Volume of Distribution (Vd) of BG-C0902, Total Antibody, and Payload
Time frame: Two times in the first three months
Phase 1a and 1b: Number of Participants with Anti-drug Antibodies (ADAs) to BG-C0902
Time frame: Approximately 24 Months
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