Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug3977 | Simulation Intervention Wiki | 1.00 |
drug1116 | Control Wiki | 0.27 |
Name (Synonyms) | Correlation | |
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D000077195 | Squamous Cell Carcinoma of Head and Neck NIH | 0.71 |
D002292 | Carcinoma, Renal Cell NIH | 0.50 |
D002277 | Carcinoma NIH | 0.30 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0005584 | Renal cell carcinoma HPO | 0.50 |
HP:0030731 | Carcinoma HPO | 0.30 |
Navigate: Correlations HPO
There is one clinical trial.
This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic, and potential clinical benefit of PF-07209960, an anti-PD-1 targeting IL-15 fusion protein, in participants with selected locally advanced or metastatic solid tumors for whom no standard therapy is available, or would not be an appropriate option in the opinion of the participant and their treating physician, or participants who have refused standard therapy. The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07209960, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
Description: DLTs will be evaluated during Cycle 1 (a cycle is 28 days) in Part 1. The number of DLTs will be used to determine the optimal dose
Measure: Number of participants with dose limiting toxicities (DLTs) in Dose Escalation (Part 1) Time: Baseline through 28 days after first dose (Cycle 1)Description: AEs as characterized by type, frequency, severity (graded by CTCAE v.5.0; CRS graded by ASTCT criteria), timing, seriousness, and relationship to study drug
Measure: Number of participants with adverse events (AEs) Time: Baseline through up to 2 yearsDescription: Laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE v.5.0), and timing
Measure: Number of participants with clinically significant laboratory abnormalities Time: Baseline through up to 2 yearsDescription: Tumor response based on RECIST 1.1
Measure: Objective response rate (ORR) in the Expansion cohorts (Part 2) Time: Baseline through up to 2 years or until disease progressionDescription: Tumor response based on RECIST 1.1
Measure: ORR in Dose Escalation (Part 1) Time: Baseline through up to 2 years or until disease progressionDescription: PK assessment for PF-07209960
Measure: Single dose: Maximal concentration (Cmax) Time: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 yearsDescription: PK assessment for PF-07209960
Measure: Single dose: Time to maximal plasma concentration (Tmax) Time: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 yearsDescription: PK assessment for PF-07209960
Measure: Single dose: Area Under the Curve within one dosing interval (AUCtau) Time: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 yearsDescription: PK assessment for PF-07209960
Measure: Multiple dose: Maximum observed steady state plasma concentration (Cmax,ss) Time: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 yearsDescription: PK assessment for PF-07209960
Measure: Multiple dose: Time to reach Maximum Observed Steady State Plasma Concentration (Tmax,ss) Time: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 yearsDescription: PK assessment for PF-07209960
Measure: Multiple dose: Area Under the curve within one dose interval at steady state (AUCtau,ss) Time: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 yearsDescription: PK assessment for PF-07209960
Measure: Lowest concentration (Ctrough) reached before the next dose is administered Time: Cycle 1 (each cycle is 28 days), Cycle 2, and day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 yearsDescription: Incidence, titers, and endogenous IL-15 cross-reactivity of anti-drug antibody and neutralizing antibody against PF-07209960
Measure: Immunogenicity in Expansion Cohorts (Part 2) Time: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 yearsDescription: Effect of PF-07209960 therapy on immune cells in tumor biopsies
Measure: Intratumor T cells in pre-treatment vs. on-treatment tumor biopsy samples in Expansion Cohorts (Part 2) Time: Baseline through start of Cycle 2Description: DCR as assessed using RECIST 1.1
Measure: Disease control rate (DCR) Time: Baseline through up to 2 years or until disease progressionDescription: DOR as assessed using RECIST 1.1
Measure: Duration of response (DOR) Time: Baseline through up to 2 years or until disease progressionDescription: TTP as assessed using RECIST 1.1
Measure: Time to progression (TTP) Time: Baseline through up to 2 years or until disease progressionDescription: PFS as assessed using RECIST 1.1
Measure: Progression free survival (PFS) Time: Baseline through up to 2 years or until disease progressionDescription: Proportion of participants alive
Measure: Overall survival (OS) in the Expansion Cohorts (Part 2) Time: Baseline through up to 2 yearsAlphabetical 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