The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.
This new study will check how safe and helpful a potential anticancer drug called BG-C477 is. This drug will be tested by itself or combined with other anticancer agents. The purpose of this study is to test if BG-C477 is safe and if it works in people with your disease when it is given on its own and in combination with other anticancer agents. Note: 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
310
Administered intravenously.
Administered intravenously.
Administered in accordance with relevant local guidelines and/or prescribing information.
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including findings from abnormal laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined Adverse Event of Clinical Interest (AECI) criteria.
Time frame: From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
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 1 year
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C477
RDFE of BG-C477 monotherapy will be determined based upon available data.
Time frame: Approximately 1 year
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 assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Time frame: Approximately 2 years
Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C477
RP2D of BG-C477 alone and in combination with anticancer agents will be determined based upon available data.
Time frame: Approximately 2 years
Phase 1a: ORR
ORR is defined as the percentage of participants with best overall response of CR or PR, as assessed by the investigator per RECIST v1.1.
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City of Hope Phoenix Cancer Center
Goodyear, Arizona, United States
RECRUITINGCity of Hope National Medical Center
Duarte, California, United States
RECRUITINGUniversity of Colorado Cancer Center
Aurora, Colorado, United States
RECRUITINGYale University Yale Cancer Center
New Haven, Connecticut, United States
RECRUITINGOsf Saint Francis Medical Center
Peoria, Illinois, United States
RECRUITINGThe University of Kansas Cancer Center
Westwood, Kansas, United States
RECRUITINGUniversity of Mississippi Medical Center (Ummc)
Jackson, Mississippi, United States
RECRUITINGJohn Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States
RECRUITINGThe University of Texas Md Anderson Cancer Center
Houston, Texas, United States
RECRUITINGTexas Oncology Longview
Longview, Texas, United States
RECRUITING...and 49 more locations
Time frame: Approximately 1 year
Phase 1a and 1b: Duration of Response (DOR)
DOR is defined as the time from the first determination of an objective response until first documentation of disease progression or death due to any cause, whichever occurs first, as assessed by the investigator per RECIST Version 1.1.
Time frame: Approximately 2 years
Phase 1a and 1b: Disease Control Rate (DCR)
DCR is defined as the percentage of participants who achieve best overall response of CR, PR, or stable disease, as assessed by the investigator per RECIST Version 1.1.
Time frame: Approximately 2 years
Phase 1b: Progression-Free Survival (PFS)
PFS is defined as the time from the first administration of study drug(s) to the date of first documentation of disease progression or death due to any cause, whichever occurs first, as assessed by the investigator per RECIST Version 1.1.
Time frame: Approximately 2 years
Phase 1b: Number of Participants with AEs and SAEs
Number of participants with AEs and SAEs, including findings from physical examinations, laboratory assessments, and that meet protocol-defined DLT criteria or protocol-defined AECI criteria.
Time frame: From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-C477 antibody-drug conjugate (ADC), BG-C477 total antibody, and free payload
Time frame: Approximately 2 months
Phase 1a and 1b: Minimum concentration (Cmin) of BG-C477
Time frame: Approximately 2 months
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-C477
Time frame: Approximately 2 months
Phase 1a and 1b: Area under the concentration-versus-time curve during dosing interval (AUCtau) of BG-C477
Time frame: Approximately 2 months
Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-C477
Time frame: Approximately 2 months
Phase 1a and 1b: Systemic clearance (CL/F) of BG-C477
Time frame: Approximately 2 months
Phase 1a and 1b: Apparent volume of distribution at steady state (Vss) of BG-C477
Time frame: Approximately 2 months
Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs) against BG-C477
Time frame: Approximately 2 years