Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There is one clinical trial.
The primary purpose of this study is to understand the safety of NL-201 when given intravenously as monotherapy in patients with advanced cancer to evaluate tolerability and to identify a recommended dose and schedule for further testing.
Description: Evaluation of tolerability of NL-201 as measured by number of subjects with dose limiting toxicities (DLTs)
Measure: Recommended phase 2 dose (RP2D) for NL-201 Time: Up to Day 33Description: Evaluation of tolerability of NL-201 as measured by number of subjects with dose limiting toxicities (DLTs)
Measure: Recommended dose schedule for NL-201 Time: Up to Day 33Description: Rate of adverse events in patients with advanced solid tumors
Measure: Incidence of treatment-emergent adverse events Time: Up to Day 33Description: Rate of adverse event grades in patients with advanced solid tumors
Measure: Severity of treatment-emergent adverse events Time: Up to Day 33Description: Based on Investigator assessment of radiographic imaging
Measure: Best Objective Response according to RECIST version 1.1 Time: Up to 36 monthsDescription: Based on Investigator assessment of radiographic imaging
Measure: Objective Response Rate (ORR) according to RECIST version 1.1 Time: Up to 36 monthsDescription: Based on Investigator assessment of radiographic imaging
Measure: Progression-Free Survival (PFS) according to RECIST version 1.1 Time: Up to 36 monthsDescription: Based on Investigator assessment of radiographic imaging
Measure: Duration of Response (DOR) according to RECIST version 1.1 Time: Upto 36 monthsDescription: Prespecified timepoints in serum before and after dosing with NL-201.
Measure: Pharmacokinetic (PK) profile of NL-201 by half-life (t1/2) Time: Up to 24 MonthsDescription: Prespecified timepoints in serum before and after dosing with NL-201.
Measure: Pharmacokinetic (PK) profile of NL-201 by area under the plasma concentration time curve (AUC) Time: Up to 24 monthsDescription: Prespecified timepoints in serum before and after dosing with NL-201.
Measure: Pharmacokinetic (PK) profile of NL-201 by maximum observed plasma concentration (Cmax) Time: Up to 24 monthsDescription: Prespecified timepoints in serum before and after dosing with NL-201.
Measure: Pharmacokinetic (PK) profile of NL-201 by volume of distribution (Vd) Time: Up to 24 MonthsDescription: Anti-drug antibodies in serum during and after treatment with NL-201
Measure: Immunogenicity of NL-201 Time: Up to 24 monthsDescription: Based on appropriate assay
Measure: Flow cytometry analysis of immune cells in blood Time: Up to 36 monthsDescription: Based on appropriate assay
Measure: Serum measurements of inflammatory cytokine levels Time: Up to 36 monthsDescription: Based on appropriate assay
Measure: Analysis of immune characteristics of the tumor microenvironment Time: Up to 36 monthsDescription: Based on Investigator assessment of imaging
Measure: Estimate additional measures of anti-tumor activity of NL- 201 per iRECIST criteria Time: Up to 36 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 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