Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There is one clinical trial.
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of MGC018 administered alone and in combination with MGA012 in patients with advanced solid tumors.
Description: Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.
Measure: Incidence of Adverse Events of MGC018 and MGC018 + MGA012 as assessed by CTCAE v4.03 Time: 30 days after last doseDescription: Maximum tolerated or maximum administered dose of MGC018 and MGC018 + MGA012
Measure: Maximum Tolerated Dose Time: up to 42 days from first doseDescription: Efficacy assessed as best overall response rate using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Measure: Preliminary anti-tumor activity of MGC018 and MGC018+MGA012 Time: 24 monthsDescription: Percent of prostate cancer patients with at least 50% reduction in prostate-specific antigen (PSA)
Measure: PSA response rate Time: 24 monthsDescription: For prostate cancer patients, time from first dose to first radiographic progression in soft tissue or bone, or death from any cause
Measure: Radiographic progression-free survival Time: 24 monthsDescription: For prostate cancer patients, change from baseline in pain intensity as measured by the Brief Pain Inventory-Short Form scale
Measure: Patient-reported Outcome Time: 24 monthsDescription: Area under the plasma concentration versus time curve of MGC018 and MGC018+MGA012
Measure: Area under the curve Time: 24 monthsDescription: Maximum Plasma Concentration of MGC018 and MGC018+MGA012
Measure: Cmax Time: 24 monthsDescription: Time to reach maximum (peak) plasma concentration of MGC018 and MGC018+MGA012
Measure: Tmax Time: 24 monthsDescription: Trough plasma concentration of MGC018 and MGC018+MGA012
Measure: Ctrough Time: 24 monthsDescription: Total body clearance of the drug from plasma of MGC018 and MGC018+MGA012
Measure: CL Time: 24 monthsDescription: Apparent volume of distribution at steady state of MGC018 and MGC018+MGA012
Measure: Vss Time: 24 monthsDescription: Terminal half life of MGC018 and MGC018+MGA012
Measure: t1/2 Time: 24 monthsDescription: Percent of patients with anti-drug antibodies against MGC018 and MGA012
Measure: Immunogenicity Time: 24 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports