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Sections: Correlations,
Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2462 | MGC018 Wiki | 0.45 |
| drug2461 | MGA012 Wiki | 0.45 |
| drug3038 | PF-07104091 + palbociclib + letrozole Wiki | 0.45 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3428 | Prototype swab Wiki | 0.45 |
| drug1718 | Fruquintinib Wiki | 0.45 |
| drug1130 | Control swab Wiki | 0.45 |
| drug4424 | Tislelizumab Wiki | 0.45 |
| drug3039 | PF-07104091 monotherapy Wiki | 0.45 |
| drug3037 | PF-07104091 + palbociclib Wiki | 0.45 |
| drug1013 | Clofazimine Wiki | 0.45 |
| drug401 | Association atezolizumab + BDB001+ RT Wiki | 0.32 |
| drug109 | ADCT-301 Wiki | 0.32 |
| drug2153 | Interferon beta-1b Wiki | 0.26 |
| drug3124 | Pembrolizumab Wiki | 0.26 |
| drug400 | Association atezolizumab + BDB001 + RT Wiki | 0.22 |
| drug4690 | Vitamin C Wiki | 0.12 |
| drug1116 | Control Wiki | 0.12 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D010051 | Ovarian Neoplasms NIH | 0.26 |
| D055752 | Small Cell Lung Carcinoma NIH | 0.26 |
| D002292 | Carcinoma, Renal Cell NIH | 0.22 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0030357 | Small cell lung carcinoma HPO | 0.26 |
| HP:0100615 | Ovarian neoplasm HPO | 0.26 |
| HP:0005584 | Renal cell carcinoma HPO | 0.22 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002894 | Neoplasm of the pancreas HPO | 0.20 |
| HP:0012125 | Prostate cancer HPO | 0.18 |
| HP:0030358 | Non-small cell lung carcinoma HPO | 0.18 |
| HP:0003002 | Breast carcinoma HPO | 0.17 |
| HP:0030731 | Carcinoma HPO | 0.13 |
| HP:0100526 | Neoplasm of the lung HPO | 0.11 |
| HP:0002664 | Neoplasm HPO | 0.07 |
Navigate: Correlations HPO
There are 5 clinical trials
This study evaluates ADCT-301 in patients with Selected Advanced Solid Tumors. Patients will participate in a Treatment Period with 3-week cycles and a Follow-up Period every 12 weeks for up to 1 year after treatment discontinuation.
Description: An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
Measure: Assessment of Dose Limiting Toxicities in Determination of the Maximum Tolerated Dose Limiting toxicities as defined per protocol, as related to ADCT-301 Time: Up to 3 yearsDescription: Adverse events will be graded according to CTAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5.
Measure: Number of Adverse Events of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above Time: Up to 3 yearsDescription: A SAE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization of prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above.
Measure: Number of Serious Adverse Events (SAE) Time: Up to 3 yearsDescription: AEs will be graded according to CTCAE v.4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5.
Measure: Number of SAEs of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above Time: Up to 3 yearsDescription: Overall response rate (ORR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine Time: Up to 3 yearsDescription: Duration of response (DOR) defined as the time from the first documentation of tumor response to disease progression as per RECIST v1.1
Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine Time: Up to 3 yearsDescription: Progression-free survival (PFS) defined as the time between start of treatment and the first documentation of recurrence or progression as per RECIST v1.1
Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine Time: Up to 3 yearsDescription: Overall survival (OS) defined as the time between the start of treatment and death from any cause
Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine Time: Up to 3 yearsDescription: Noncompartmental analysis of the maximum concentration (Cmax)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of the time to maximum concentration (Tmax)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of the area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0 last)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of the area under the concentration-time curve from time zero to infinity (AUC0-∞)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of the area under the concentration-time curve from time zero to the end of the dosing interval (AUC0-τ)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of the accumulation index (AI)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of clearance (CL)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of volume of distribution (Vd)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: ADA titers if applicable, neutralizing activity to camidanlumab tesirine after treatment with camidanlumab tesirine.
Measure: Number of confirmed positive anti-drug antibody (ADA) responses Time: Up to 3 yearsThe purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of MGC018 administered alone and in combination with MGA012 in patients with advanced solid tumors.
Description: Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.
Measure: Incidence of Adverse Events of MGC018 and MGC018 + MGA012 as assessed by CTCAE v4.03 Time: 30 days after last doseDescription: Maximum tolerated or maximum administered dose of MGC018 and MGC018 + MGA012
Measure: Maximum Tolerated Dose Time: up to 42 days from first doseDescription: Efficacy assessed as best overall response rate using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Measure: Preliminary anti-tumor activity of MGC018 and MGC018+MGA012 Time: 24 monthsDescription: Percent of prostate cancer patients with at least 50% reduction in prostate-specific antigen (PSA)
Measure: PSA response rate Time: 24 monthsDescription: For prostate cancer patients, time from first dose to first radiographic progression in soft tissue or bone, or death from any cause
Measure: Radiographic progression-free survival Time: 24 monthsDescription: For prostate cancer patients, change from baseline in pain intensity as measured by the Brief Pain Inventory-Short Form scale
Measure: Patient-reported Outcome Time: 24 monthsDescription: Area under the plasma concentration versus time curve of MGC018 and MGC018+MGA012
Measure: Area under the curve Time: 24 monthsDescription: Maximum Plasma Concentration of MGC018 and MGC018+MGA012
Measure: Cmax Time: 24 monthsDescription: Time to reach maximum (peak) plasma concentration of MGC018 and MGC018+MGA012
Measure: Tmax Time: 24 monthsDescription: Trough plasma concentration of MGC018 and MGC018+MGA012
Measure: Ctrough Time: 24 monthsDescription: Total body clearance of the drug from plasma of MGC018 and MGC018+MGA012
Measure: CL Time: 24 monthsDescription: Apparent volume of distribution at steady state of MGC018 and MGC018+MGA012
Measure: Vss Time: 24 monthsDescription: Terminal half life of MGC018 and MGC018+MGA012
Measure: t1/2 Time: 24 monthsDescription: Percent of patients with anti-drug antibodies against MGC018 and MGA012
Measure: Immunogenicity Time: 24 monthsBasket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.
Description: Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.
Measure: Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with pancreatic cancer. Time: Within 6 months of treatment onsetDescription: Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.
Measure: Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with virus associated tumors. Time: Within 6 months of treatment onsetDescription: Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.
Measure: Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with non-small cell lung cancer. Time: Within 6 months of treatment onsetDescription: Antitumor activity will be assessed in terms of 6-month progression-free rat (PFR) and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed at 6 months following treatment onset and more than 24 weeks, based on RECIST 1.1 criteria.
Measure: Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with soft-tissue sarcoma. Time: 6 months of treatment onsetDescription: Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.
Measure: Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with bladder cancer. Time: Within 6 months of treatment onsetDescription: Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.
Measure: Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with triple negative breast cancer. Time: Within 6 months of treatment onsetDescription: Progression-free rate is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST 1.1 criteria.
Measure: 6-month Progression-free rate (PFR) in patients with pancreatic cancer. Time: 6 monthsDescription: Progression-free rate is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST 1.1 criteria.
Measure: 6-month Progression-free rate (PFR) in patients with virus-associated tumor. Time: 6 monthsDescription: Progression-free rate is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST 1.1 criteria.
Measure: 6-month Progression-free rate (PFR) in patients with non-small cell lung cancer. Time: 6 monthsDescription: Progression-free rate is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST 1.1 criteria.
Measure: 6-month Progression-free rate (PFR) in patients with bladder cancer. Time: 6 monthsDescription: Progression-free rate is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST 1.1 criteria.
Measure: 6-month Progression-free rate (PFR) in patients with triple negative breast cancer. Time: 6 monthsDescription: Objective response is defined as the proportion of patients with complete response (CR) or partial response (PR) observed at 6 months, based on RECIST 1.1 criteria.
Measure: 6-month objective response rate (ORR) independently for each population. Time: 6 monthsDescription: Objective response is defined as the proportion of patients with complete response (CR) or partial response (PR) observed within 24 wekks after treatment onset, based on RECIST 1.1 criteria.
Measure: Objective response rate (ORR) within 24 weeks of treatment onset, independently for each population. Time: Within 6 monthsDescription: Best overall response is defined as the best response across all time points (RECIST 1.1). The best overall response is determined once all the data for the patient is known (RECIST 1.1).
Measure: Best overall response, independently for each population. Time: Throughout the treatment period, an expected average of 6 monthsDescription: Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first.
Measure: 1-year progression-free survival, independently for each population. Time: 1 yearDescription: Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first.
Measure: 2-year progression-free survival, independently for each population. Time: 2 yearsDescription: Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).
Measure: 1-year overall survival, independently for each population. Time: 1 yearDescription: Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).
Measure: 2-year overall survival, independently for each population. Time: 2 yearsDescription: Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.
Measure: Safety profile, independently for each population: Common Terminology Criteria for Adverse Events version 5 Time: Throughout the treatment period, an expected average of 6 monthsDescription: Levels of immune cells in tumor will be measured by immunohistochemistry.
Measure: Tumor immune cells levels Time: before treatment onset and cycle 3 day 1 (each cycle is 21 days)Description: Levels of cytokines in blood will be measured by ELISA.
Measure: Blood cytokines levels Time: baseline, cycle 1 day 1, cycle 2 day 1, cycle 3 day 1 and progression (each cycle is 21 days)Description: Levels of lymphocytes in blood will be measured by flow cytometry.
Measure: Blood lymphocytes levels Time: baseline, cycle 1 day 1, cycle 2 day 1, cycle 3 day 1 and progression (each cycle is 21 days)Description: Levels of kynurenine in blood will be measured by ELISA.
Measure: Blood kynurenine levels Time: baseline, cycle 1 day 1, cycle 2 day 1, cycle 3 day 1 and progression (each cycle is 21 days)To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF 07104091 as a single agent in participants with small cell lung, non small cell lung ovarian and breast cancers.
Description: Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level
Measure: Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle Time: 28 daysDescription: Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities will be summarized by dose level
Measure: To evaluate incidence of treatment emergent adverse events and laboratory abnormalities Time: From baseline until end of study treatment or study completion (approximately 2 years)Description: Identify pulse rate readings that are outside the normal range. The number and percentage of participants who experienced significant pulse rate change from baseline will be summarized by dose level
Measure: Evaluate pulse rate that is out of normal range and changes in pulse rate as compared to baseline Time: From baseline until end of study treatment or study completion (approximately 2 years)Description: Identify systolic and diastolic readings that are outside the normal range. The number and percentage of participants who experienced significant blood pressure change from baseline will be summarized by dose level
Measure: Evaluate blood pressure that is out of normal range and changes in blood pressure as compared to baseline Time: From baseline until end of study treatment or study completion (approximately 2 years)Description: Determine the effect of the drug on QT prolongation. The number and percentage of participants who experienced QT interval prolongation will be summarized by dose level
Measure: To evaluate heart rate corrected QT interval and changes in corrected QT interval as compared to baseline Time: From baseline until end of study treatment or study completion (approximately 2 years)Description: Percentage of participants with a best overall response of complete response (CR) or partial response (PR) using RECIST 1.1
Measure: To evaluate the preliminary antitumor activity of PF-07104091 as a single agen and in combination with palbociclib and in combination with letrozole by objective response rate (ORR) in dose expansion Time: From baseline through disease progression or study completion (approximately 2 years)Description: Peak concentration of PF-07104091 during selected cycles
Measure: Maximum plasma concentration (Cmax) of PF-07104091 after a single dose and multiple dose Time: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)Description: Time to peak concentration of PF-07104091 during selected cycles
Measure: Time to maximum plasma concentration (Tmax) of PF-07104091 after a single dose and multiple dose Time: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)Description: AUC of PF-07104091 will be calculated at selected cycles
Measure: Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07104091 Time: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)Description: AUC of PF-07104091 in plasma and whether absorption of the drug is affected when taken by food
Measure: Area under the curve of PF-07104091 with or without food Time: From baseline through time to event on study or study completion (approximately 2 years)Description: Peak concentrations of PF-07104091 in plasma and whether absorption of the drug is affected when taken by food
Measure: Maximum plasma concentration of PF-07104091 with or without food Time: From baseline through time to event on study or study completion (approximately 2 years)Description: Percentage of participants with a best overall response of CR or PR using RECIST 1.1
Measure: To document any preliminary evidence of antitumor activity of PF-07104091 as a single agen and in combination with palbociclib and in combination with letrozole by objective response rate (ORR) in dose escalation Time: From baseline and every 8 weeks through disease progression or study completion (approximately 2 years)Description: Time from first assessment of event endpoint to last assessment of using RECIST 1.1
Measure: To document any preliminary evidence of antitumor activity of PF-07104091 by time to event endpoints Time: From baseline through time to event on study or study completion (approximately 2 years)This is an open-label, multi-center, non-randomized, Phase 1b/2 study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced, refractory TNBC. This study will be conducted in 2 parts; a safety lead-in phase (Part 1) and a dose expansion phase (Part 2). The safety lead-in phase will determine the RP2D. The RP2D will be administered to 2 cohorts of patients in the expansion phase. - Cohort A: TNBC (IO-treated) - Cohort B: TNBC (IO-Naïve)
Description: To assess the safety and tolerability by monitoring AEs characterized by type, frequency, severity per NCI-CTCAE v5.0
Measure: Adverse Events by type, frequency, and severity Time: At the end of Cycle 1 (each cycle is 28 days)Description: To confirm the RP2D of fruquintinib in combination with tislelizumab
Measure: Recommended Phase 2 Dose Time: At the end of Cycle 1 (each cycle is 28 days)Description: To evaluate the objective response rate (ORR) as assessed by the investigator in subjects with advanced TNBC when treated with fruquintinib in combination with tislelizumab
Measure: Objective Response Rate Time: Up to 1 yearAlphabetical 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