The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 alone and in combination with anticancer agents in participants with advanced solid tumors. The study will be conducted in two phases: Phase 1a (Monotherapy Dose Escalation, and Safety Expansion; Combination Dose Confirmation 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
168
Administered intravenously
Administered intravenously or orally
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, United States
RECRUITINGYale Cancer Center
New Haven, Connecticut, United States
RECRUITINGMayo Clinic Rochester
Rochester, Minnesota, United States
RECRUITINGMd Anderson Cancer Center
Houston, Texas, United States
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version (NCI CTCAE 5.0)), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria and AEs meeting protocol-defined adverse event of clinical interest (AECIs)
Time frame: Up to approximately 2 years
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C137
The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to a target toxicity rate, or the highest dose administered, respectively.
Time frame: Up to approximately 2 years
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C137 as monotherapy and in combination with anticancer agents
RDFE(s) is determined based on relevant data, as available
Time frame: Up to approximately 2 years
Phase 1b: The recommended Phase 2 dose (RP2D) of BG-C137
The RP2D of BG-C137 monotherapy will be determined based on relevant data, as available
Time frame: Up to approximately 2 years
Phase 1b: Overall Response Rate (ORR)
ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Up to approximately 2 years
Phase 1a: ORR
ORR is defined as the percentage of participants with CR or PR, as determined by RECIST v1.1
Time frame: Up to approximately 2 years
Phase 1a and 1b: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with best overall response of a CR, PR, and stable disease, as assessed by RECIST v1.1
Time frame: Up to approximately 2 years
Phase 1a and 1b: 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 progression or death, whichever comes first, as assessed using RECIST v1.1
Time frame: Up to approximately 2 years
Phase 1b: Progression Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of progressive disease assessed using RECIST v1.1 or death, whichever occurs first
Time frame: Up to approximately 2 years
Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version (NCI CTCAE 5.0), and AEs meeting protocol-defined adverse event of clinical interest (AECI)s.
Time frame: Up to approximately 2 years
Phase 1a: Plasma concentrations of BG-C137 analytes
Time frame: Up to approximately 1 year; at the end of treatment (maximum of 2 years) and at the first safety follow-up visit (30 days after last dose)
Phase 1b: Plasma concentrations of BGB-C137 analytes
Time frame: Up to approximately 1 year; at the end of treatment (maximum of 2 years) and at the first safety follow-up visit (30 days after last dose)
Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-C137 analytes
Time frame: Twice in the first 3 months
Phase 1a: Time to reach maximum observed plasma concentration (Tmax) of BGB-C137 analytes
Time frame: Twice in the first 3 months
Phase 1a: Minimum Observed Plasma Concentration (Ctrough) Of BGB-C137 analytes
Time frame: Twice in the first 3 months
Phase 1a: Area Under the Plasma Concentration-time Curve (AUC) of BGB-C137 analytes
Time frame: Twice in the first 3 months
Phase 1a: Terminal Half-Life (t1/2) of BGB-C137 analytes
Time frame: Twice in the first 3 months
Phase 1a and 1b: Incidence of Antidrug Antibodies (ADAs) to BGB-C137
Time frame: Up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
RECRUITINGUniversity of Wisconsin
Madison, Wisconsin, United States
RECRUITINGBlacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
RECRUITINGLiverpool Hospital
Liverpool, New South Wales, Australia
RECRUITINGIcon Cancer Centre South Brisbane
South Brisbane, Queensland, Australia
RECRUITINGMonash Health
Clayton, Victoria, Australia
RECRUITING...and 21 more locations