A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BGC515 Capsules in Patients With Advanced Solid Tumors
Summary
The goal of this open-label, dose escalation and dose expansion Phase I clinical trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BGC515 administered once daily in 3 weeks cycles in solid tumor patients.
Arms & interventions
- DrugBGC515
Capsules for oral administration
Outcome measures
Primary
Incidence of adverse events (AEs) and serious adverse events (SAEs).
AEs will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. AE evaluation will be based on laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram, etc.
Time frame: Through study completion, approximately 1 year.
Dose-limiting toxicities (DLTs)
DLT refers to the pre-specified AEs that occurred within 24 days after the first dose of study drug.
Time frame: Within 24 days after the first dose of study drug.
Objective response rate (ORR)
Defined as the percentage of participants having complete response (CR) or partial response (PR). Evaluated by the Investigator based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) or Response Evaluation Criteria in Solid Tumors (RECIST) V1.1.
Time frame: Through study completion, approximately 3 years.
Progress-free survival(PFS)
Defined as the time interval between the first dose of the treatment and the first documented disease progression or death due to any cause (whichever occurs first). Evaluated by the Investigator based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) or Response Evaluation Criteria in Solid Tumors (RECIST) V1.1.
Time frame: Through study completion, approximately 3 years.
Secondary
Peak concentration (Cmax).
Time frame: Multiple time points, up to approximately 1 year.
Time to peak concentration (Tmax).
Time frame: Multiple time points, up to approximately 1 year.
Half-life (t1/2).
Time frame: Multiple time points, up to approximately 1 year.
Area under the concentration-time curve from time zero to the last detectable plasma concentration (AUC0-t).
Time frame: Multiple time points, up to approximately 1 year.
Eligibility criteria
Study locations (1)
MD Anderson Cancer Center
Houston, Texas, 77030