A Phase 1a/b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C137, an Antibody-Drug Conjugate Targeting FGFR2b, in Patients With Advanced Solid Tumors
Summary
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).
Detailed description
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.
Arms & interventions
- DrugBG-C137
Administered intravenously
- DrugAnticancer Agents
Administered intravenously or orally
Outcome measures
Primary
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
Secondary
Phase 1a: ORR
Time frame: Up to approximately 2 years
Phase 1a and 1b: Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Phase 1a and 1b: Duration of Response (DOR)
Time frame: Up to approximately 2 years
Phase 1b: Progression Free Survival (PFS)
Time frame: Up to approximately 2 years
Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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
Eligibility criteria
Study locations (6)
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, 90089-1019
Yale Cancer Center
New Haven, Connecticut, 06510
Mayo Clinic Rochester
Rochester, Minnesota, 55905-0001
Md Anderson Cancer Center
Houston, Texas, 77030-3907
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4433
University of Wisconsin
Madison, Wisconsin, 53792-0001