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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| Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There is one clinical trial.
GNX-001 is an open-label, phase 1, multicenter, dose-escalation and expansion study of GNX102 infused every 21 days. Approximately 30 patients may be enrolled in the dose escalation portion of this study. Once the MTD or recommended phase 2 dose (RP2D) has been identified, up to 15 additional patients may be enrolled in one or two expansion cohort(s) at one or two dose levels recommended by the Safety Review Committee) to confirm the safety profile of the RP2D and provide additional information on anti-tumor activity. Patients with adeno- or epithelial-cancers that have a likelihood of GNX102 targeted antigen expression based on previous studies, including colorectal, hepatocellular, non-small cell lung, gastric, breast, pancreatic, cutaneous, acral, or mucosal melanoma, esophageal, prostate, and epithelial uterine cancers, can be screened for enrollment in the study.
Description: If ≤ 1 of 6 patients has a dose limiting toxicity (DLT) after all previous dose testing the dose will be declared the Maximum Tolerable Dose (MTD).
Measure: maximum tolerated dose (MTD) Time: Through study completion, an average of 2 yearsDescription: To evaluate antitumor activity of GNX102 by objective radiographic assessment
Measure: Antitumor activity of GNX102 Time: Through study completion, an average of 2 yearsDescription: To determine the AUC Area under the concentration curve of GNX102
Measure: AUC: Area under the concentration curve of GNX102 (μg × h/mL) Time: Through study completion, an average of 2 yearsDescription: To determine the pharmacokinetics (PK) of GNX102
Measure: Cmax: Maximum plasma concentration of GNX102 (μg) Time: Through study completion, an average of 2 yearsDescription: To determine the pharmacokinetics (PK) of GNX102
Measure: Tmax: Time to maximum plasma concentration of GNX102 (minutes) Time: Through study completion, an average of 2 yearsDescription: To determine the pharmacokinetics (PK) of GNX102
Measure: t1/2: Terminal phase half-life of GNX102 (minutes) Time: Through study completion, an average of 2 yearsDescription: To determine the pharmacokinetics (PK) of GNX102
Measure: CL: Clearance of GNX102 (L/hr) Time: Through study completion, an average of 2 yearsDescription: To determine the pharmacokinetics (PK) of GNX102
Measure: Vz: Apparent volume of distribution in the terminal phase of GNX102 (L) Time: Through study completion, an average of 2 yearsDescription: Dose-limiting AEs and toxicities will be used to establish the MTD and the recommended dose for phase 2 studies (RP2D)
Measure: Number of adverse events (AEs) and number of toxicities Time: Through study completion, an average of 2 yearsDescription: To explore tumor expression of GNX102 targeted antigens as a biomarker to predict toxicity or response to GNX102
Measure: Exploratory Outcome: GNX102 targeted antigens (counts) Time: Through study completion, an average of 2 yearsDescription: To explore serum LeB / LeY antigen levels as a potential biomarker to predict toxicity or response to GNX102
Measure: Exploratory Outcome: Serum LeB / LeY antigen levels (counts) Time: Through study completion, an average of 2 yearsDescription: To explore biomarkers related to cancer type to predict toxicity or response to GNX102
Measure: Exploratory Outcome: Serum tumor-specific antigen levels (counts) Time: Through study completion, an average of 2 yearsDescription: To evaluate the development of anti-drug antibody (ADA) to GNX102
Measure: Exploratory Outcome: Anti-drug antibody (ADA) to GNX102 (counts) Time: Through study completion, an average of 2 yearsAlphabetical 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