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.
A phase 1, open-label, first-in-human study of T3011 monotherapy to evaluate the safety and tolerability of T3011 in patients with advanced cancers with cutaneous or subcutaneous tumor deposits who have progressed while receiving standard of care therapy or who will not benefit from such therapy.
Description: Number of participants in dose escalating arm with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Measure: Safety and tolerability of T3011 in dose escalating administration in patients with advanced cutaneous or subcutaneous malignancies Time: From first dose of T3011 (Week 1 Day 1) until 60 days after the last T3011 injection (up to 2 years)Description: Number of participants in dose expansion arm with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Measure: Safety and tolerability of T3011 in dose expansion administration in patients with advanced cutaneous or subcutaneous malignancies Time: From first dose of T3011 (Week 1 Day 1) until 60 days after the last T3011 injection (up to 2 years)Description: To evaluate the virus shedding following intratumoral injection
Measure: Presence and frequency of T3011 in serum, saliva, urine, and injection site/dressing Time: Up to 24 monthsDescription: To evaluate IL-12 and anti-PD-1 antibody expression of T3011 post intervention.
Measure: Quantitative measurements of serum IL-12 and anti-PD-1 antibody concentration. Time: Up to 24 monthsDescription: To evaluate the immunogenicity of anti-PD-1 antibody expressed by T3011 post intervention.
Measure: Presence of neutralizing antibodies of anti-PD-1 antibody for antidrug antibodies (ADAs) development Time: Up to 24 monthsDescription: To evaluate the immunogenicity of T3011 viral vector post intervention.
Measure: Presence of anti-herpes simplex virus type 1 (HSV-1) antibody compared to baseline Time: Up to 24 monthsDescription: ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measure: Overall response rate (ORR) Time: Up to 24 monthsDescription: DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments per RECIST 1.1.
Measure: Disease control rate (DCR) Time: Up to 24 monthsDescription: DOR is defined as the time from the first met CR or PR until disease progression or death due to any cause, whichever occurs first.
Measure: Duration of response (DOR). Time: Up to 24 monthsDescription: DR is defined as objective response (CR or PR) according to RECIST 1.1, with a duration of at least 6 months.
Measure: Durable response (DR) Time: Up to 24 monthsDescription: To evaluate the progression free survival (PFS) and overall survival (OS) of participants.
Measure: Survival (assessment per RECIST 1.1 and immune-modified RECIST (imRECIST)). Time: Up to 24 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