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Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug103 | ADCT-301 Wiki | 0.71 |
| drug1024 | Continuation of ACEi/ARB Wiki | 0.71 |
| drug140 | ASP8374 Wiki | 0.71 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D002292 | Carcinoma, Renal Cell NIH | 0.41 |
| D010190 | Pancreatic Neoplasms NIH | 0.35 |
| D064726 | Triple Negative Breast Neoplasms NIH | 0.32 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0005584 | Renal cell carcinoma HPO | 0.41 |
| HP:0002894 | Neoplasm of the pancreas HPO | 0.35 |
| HP:0030731 | Carcinoma HPO | 0.25 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002664 | Neoplasm HPO | 0.12 |
Navigate: Correlations HPO
There are 2 clinical trials
The primary purpose of this study is to evaluate the tolerability and safety profile of ASP8374 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumor malignancies. Also primary purpose is to characterize the pharmacokinetic profile of ASP8374 when administered as a single agent and in combination with pembrolizumab. Last primary purpose of this study is to determine the recommended Phase 2 dose (RP2D) of ASP8374 when administered as a single agent and in combination with pembrolizumab. The secondary purpose of this study is to evaluate the anti-tumor effect (objective response rate [ORR], duration of response [DOR], persistence of response after discontinuation, and disease control rate [DCR]) of ASP8374 when administered as a single agent and in combination with pembrolizumab.
Description: DLT as graded using National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] Version 4.03. The DLT observation period may be increased if deemed appropriate by the Dose Escalation and Safety Committee
Measure: Safety and tolerability assessed by Dose Limiting Toxicity (DLT) Time: Up to 21 daysDescription: Initial and re-treatment. An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product
Measure: Safety and tolerability assessed by adverse events (AEs) Time: Up to 30 days following the last dose of study drug or until initiation of a new anti-cancer treatment, whichever comes first of each treatment period (Up to a maximum of 52 weeks)Description: Initial and re-treatment. Most frequent immune-related AEs include rash, oral mucositis, dry mouth, colitis/diarrhea, hepatitis, pneumonitis, and endocrinopathies
Measure: Safety and tolerability assessed by immune-related AEs (irAEs) Time: Up to 30 days following the last dose of study drug or until initiation of a new anti-cancer treatment, whichever comes first of each treatment period (Up to a maximum of 52 weeks)Description: Initial and re-treatment. Adverse event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event
Measure: Safety and tolerability assessed by serious adverse events (SAEs) Time: Up to 90 days following the last dose of study drug or until initiation of a new anti-cancer treatment, whichever comes first of each treatment period (Up to a maximum of 60 weeks)Description: Initial and re-treatment. Number of participants with potentially clinically significant laboratory values. The laboratory tests include hematology, biochemistry, urine dipstick, pregnancy test, thyroid stimulating hormone (TSH) and free T4; Hepatitis B and C; Testosterone and prostate-specific antigen (PSA) (metastatic castration resistant prostate cancer (mCRPC) only)
Measure: Number of participants with laboratory value abnormalities and/or adverse events related to treatment Time: Up to 30 days from last dose in safety follow up period for each treatment period (Up to a maximum of 52 weeks)Description: Initial and re-treatment. ECGs should be obtained after the participant has rested quietly and is awake in a fully supine position (or semi-recumbent, if supine is not tolerated) for 10 minutes before the first ECG from a triplicate or single ECG. Any clinically significant adverse changes on the ECG will be reported as (serious) Adverse Event
Measure: Safety and tolerability assessed by 12-lead electrocardiogram (ECG) Time: Up to end of treatment (up to 48 weeks for each treatment period)Description: Initial and re-treatment. Number of participants with potentially clinically significant vital sign values. Vital signs will include systolic and diastolic blood pressure, radial pulse and temperature. All vital signs will be measured with the subject in the sitting or supine position
Measure: Number of participants with vital signs abnormalities and/or adverse events related to treatment Time: Up to 90 days from last dose in safety follow up period for each treatment period (Up to a maximum of 60 weeks)Description: Initial and re-treatment. Standard, full physical examinations will be performed at screening to assess general appearance, skin, eyes, ears, nose, throat, neck, cardiovascular system, chest and lungs, abdomen, musculoskeletal system, neurologic status, mental status, and lymphatic system
Measure: Number of participants with Physical Exam abnormalities and/or adverse events related to treatment Time: Up to end of treatment (up to 48 weeks for each treatment period)Description: Initial and re-treatment. The eastern cooperative oncology group (ECOG) Scale [Oken, 1982] will be used to assess performance status.0 = Fully active, able to carry on all predisease performance without restriction; 1=Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature; 2= Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3= Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4= Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
Measure: Safety and tolerability assessed by ECOG performance status Time: Up to 30 days from last dose in safety follow up period of each treatment period (Up to a maximum of 52 weeks)Description: AUClast: area under the concentration-time curve from the time of dosing to the last measurable concentration. AUClast will be derived from the PK serum samples collected.
Measure: Pharmacokinetics (PK) of ASP8374 in serum: AUClast (Initial treatment, escalation cohorts in monotherapy only) Time: Cycle 1 and 7: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdose (for cycle 1 only)Description: AUCinf: area under the concentration-time curve from the time of dosing extrapolated to time infinity. AUCinf will be derived from the PK serum samples collected.
Measure: Pharmacokinetics (PK) of ASP8374 in serum: AUCinf (Initial treatment, escalation cohorts in monotherapy only) Time: Cycle 1: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdose (for cycle 1 only)Description: AUCtau: Area under the concentration-time curve from the time of dosing to the start of the next dosing interval. AUCtau will be derived from the PK serum samples collected.
Measure: Pharmacokinetics (PK) of ASP8374 in serum: AUCtau (Initial treatment, escalation cohorts in monotherapy only) Time: Cycle 1 and 7: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdose (for cycle 1 only)Description: Cmax: maximum concentration. Cmax will be derived from the PK serum samples collected.
Measure: Pharmacokinetics (PK) of ASP8374 in serum: Cmax (Initial treatment, escalation cohorts in monotherapy only) Time: Cycle 1 and 7: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdose (cycle 1 only)Description: Ctrough: Trough concentration. Ctrough will be derived from the PK serum samples collected.
Measure: Pharmacokinetics (PK) of ASP8374 in serum: Ctrough (Initial treatment, escalation and expansion cohorts in both monotherapy and combination therapy) Time: Cycle 2, 4, 7, 10 and 15: day 1: predose 0 hrDescription: Ctrough: Trough concentration. Ctrough will be derived from the PK serum samples collected.
Measure: Pharmacokinetics (PK) of pembrolizumab in serum: Ctrough (Initial treatment, escalation cohorts in combination therapy) Time: Cycle 2, 4, 7, 10 and 15: day 1: predose 0 hrDescription: Ctrough: Trough concentration. Ctrough will be derived from the PK serum samples collected.
Measure: Pharmacokinetics (PK) of ASP8374 in serum: Ctrough (Re-treatment, escalation and expansion cohorts in both monotherapy and combination therapy) Time: Cycle 5, 10 and 15: day 1: predose 0 hrDescription: tmax: time of maximum concentration. tmax will be derived from the PK serum samples collected.
Measure: Pharmacokinetics (PK) of ASP8374 in serum: tmax (Initial treatment, escalation cohorts in monotherapy only) Time: Cycle 1 and 7: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdose (cycle 1 only)Description: t1/2: terminal elimination half-life. t1/2 will be derived from the PK serum samples collected.
Measure: Pharmacokinetics (PK) of ASP8374 in serum: t1/2 (Initial treatment, escalation cohorts in monotherapy only) Time: Cycle 1: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdoseDescription: CL: Clearance. CL will be derived from the PK serum samples collected.
Measure: Pharmacokinetics (PK) of ASP8374 in serum: CL (Initial treatment, escalation cohorts in monotherapy only) Time: Cycle 1 and 7: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdose (cycle 1 only)Description: Vz: Volume of distribution after intravenous dosing during the terminal elimination phase. Vz will be derived from the PK serum samples collected.
Measure: Pharmacokinetics (PK) of ASP8374 in serum: Vz (Initial treatment, escalation cohorts in monotherapy only) Time: Cycle 1: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdose; day 22: 504 hr postdoseDescription: Vss: Volume of distribution at steady state after intravenous dosing. Vss will be derived from the PK serum samples collected.
Measure: Pharmacokinetics (PK) of ASP8374 in serum: Vss (Initial treatment, escalation cohorts in monotherapy only) Time: Cycle 7: day 1: predose 0 hr, end of dosing, 4 hr postdose; day 2: 24 hr postdose; day 3: 48 hr postdose; day 8: 168 hr postdose; day 15: 336 hr postdoseDescription: Initial and re-treatment. 'Immune' Response Evaluation Criteria in Solid Tumors (iRECIST). ORR is defined as the proportion of participants for each dose level whose best overall response is rated as confirmed CR or PR
Measure: Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST Time: Up to end of follow up period (up to 105 weeks) of each treatment periodDescription: Initial and re-treatment. DOR will be calculated only for the subgroup of participants with confirmed response CR/PR
Measure: Duration of response (DOR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST Time: Up to end of follow up period (up to 105 weeks) of each treatment periodDescription: Initial and re-treatment. Persistence of response after discontinuation is defined for participants who discontinued the treatment and responded to the treatment per iRECIST only
Measure: Persistence of response after discontinuation by iRECIST Time: Up to end of follow up period (up to 105 weeks) of each treatment periodDescription: Initial and re-treatment. DCR is defined as the proportion of participants for each dose level whose best overall response is rated as confirmed CR, PR or Stable Disease (SD)
Measure: Disease control rate (DCR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST Time: Up to End of follow up period (up to 105 weeks) of each treatment periodThis 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 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