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Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3977 | Simulation Intervention Wiki | 0.71 |
| drug3040 | PF-07209960 Wiki | 0.71 |
| drug769 | CMP-001 Wiki | 0.71 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D002294 | Carcinoma, Squamous Cell NIH | 0.50 |
| D002277 | Carcinoma NIH | 0.43 |
| D002292 | Carcinoma, Renal Cell NIH | 0.35 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002860 | Squamous cell carcinoma HPO | 0.50 |
| HP:0030731 | Carcinoma HPO | 0.43 |
| HP:0005584 | Renal cell carcinoma HPO | 0.35 |
Navigate: Correlations HPO
There are 2 clinical trials
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 yearsCMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody. The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC) The secondary objectives are to: - To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC - To evaluate the efficacy of CMP-001 in combination with pembrolizumab in subjects with HNSCC - To evaluate the effect of human papillomavirus (HPV) infection and programmed death-ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab Participants will continue to receive treatment of CMP-001 and pembrolizumab according to the treatment schedule until a reason for treatment discontinuation is reached.
Description: Objective response is the proportion of subjects that experience confirmed complete or partial response based on RECIST v1.1.
Measure: The objective response (investigator-assessed) to CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC). Time: From first dose of CMP-001 (Week 1 Day 1) until 30 days after the last CMP-001 injection (until a reason for treatment discontinuation occurs)Description: As determined by adverse events, serious adverse events, adverse events leading to discontinuation or death, and severity of adverse events (per NCI CTCAE v 5.0).
Measure: Safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC. Time: From first dose of CMP-001 (Week 1 Day 1) until 30 days after the last CMP-001 injection (until a reason for treatment discontinuation occurs)Description: Duration of Response (DOR), defined as the time from date of first documented response (CR or PR) to date of documented progressive disease (PD), based on RECIST v1.1 by Investigator assessment (IA). Progression-free Survival (PFS), defined as the time from date of first dose of study drug to date of documented PD based on RECIST v1.1 by IA or death, whichever occurs first. Overall Survival (OS), defined as the time from the date of first dose of study drug to the date of death. iORR, defined as the proportion of subjects with a best overall response (BOR) of immune complete response (iCR) or immune partial response (iPR) based on the immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) by IA. iDOR, defined as the time from the date of the first immune response (iCR or iPR) to the date of immune confirmed progressive disease (iCPD) by IA. iPFS, defined as the time from date of first dose of study drug to date of iCPD by IA or death, whichever occurs first.
Measure: Efficacy [characterized by DOR, PFS, and OS, along with Immune Objective Response Rate (iORR), Immune Duration of Response (iDOR), and Immune Progression-free Survival (iPFS)] of CMP-001 in combination with pembrolizumab in subjects with HNSCC. Time: From first dose of CMP-001 (Week 1 Day 1) until 30 days after the last CMP-001 injection (until a reason for treatment discontinuation occurs)Description: Evaluated by examining ORR (see above), DOR (see above), and PFS (see above) based on HPV status and PD-L1 expressions (combined positive score [CPS] 20).
Measure: The effect of human papillomavirus (HPV) infection and programmed death ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab. Time: From first dose of CMP-001 (Week 1 Day 1) until 30 days after the last CMP-001 injection (until a reason for treatment discontinuation occurs)Alphabetical 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