MD Anderson Cancer Center
Houston, Texas, 77030, United States
Location status: Recruiting
NCT Number: NCT06452160
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Houston, Texas, 77030, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Capsules for oral administration
Time frame: Through study completion, approximately 1 year.
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: Within 24 days after the first dose of study drug.
DLT refers to the pre-specified AEs that occurred within 24 days after the first dose of study drug.
Time frame: Through study completion, approximately 3 years.
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.
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: Multiple time points, up to approximately 1 year.
Cmax of BGC515 in plasma.
Time frame: Multiple time points, up to approximately 1 year.
Tmax of BGC515 in plasma.
Time frame: Multiple time points, up to approximately 1 year.
t1/2 of BGC515 in plasma.
Time frame: Multiple time points, up to approximately 1 year.
(AUC0-t) of BGC515 in plasma.
Contact information is provided by the study sponsor or research team.
BridGene Biosciences Inc.
Industry
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BGC515 Capsules in Patients With Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04537715
Adenoma, Advanced Malignancies
Encinitas, California, United States
View Trial DetailsNCT03830229
Adenoma, Families
Bethesda, Maryland, United States
View Trial DetailsNCT07277413
Adenocarcinoma Of Esophagus, Adenocarcinoma of Esophagus
Santa Rosa, California, United States
View Trial DetailsNCT06057935
Adenoma, Lung Diseases
Chicago, Illinois, United States
View Trial Details