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D064726: Triple Negative Breast Neoplasms

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (10)


Name (Synonyms) Correlation
drug1929 MGC018 Wiki 0.58
drug2388 PF-07104091 monotherapy Wiki 0.58
drug876 Continuation of ACEi/ARB Wiki 0.58
Name (Synonyms) Correlation
drug83 ADCT-301 Wiki 0.58
drug853 Community based combination HIV prevention package Wiki 0.58
drug2386 PF-07104091 + palbociclib Wiki 0.58
drug1072 Discontinuation of ACEi/ARB Wiki 0.58
drug2387 PF-07104091 + palbociclib + letrozole Wiki 0.58
drug1928 MGA012 Wiki 0.58
drug2458 Pembrolizumab Wiki 0.41

Correlated MeSH Terms (8)


Name (Synonyms) Correlation
D055752 Small Cell Lung Carcinoma NIH 0.41
D002292 Carcinoma, Renal Cell NIH 0.33
D010051 Ovarian Neoplasms NIH 0.33
Name (Synonyms) Correlation
D010190 Pancreatic Neoplasms NIH 0.29
D002289 Carcinoma, Non-Small-Cell Lung NIH 0.26
D011471 Prostatic Neoplasms NIH 0.26
D002277 Carcinoma NIH 0.20
D008175 Lung Neoplasms NIH 0.18

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0005584 Renal cell carcinoma HPO 0.33
HP:0002894 Neoplasm of the pancreas HPO 0.29
HP:0030731 Carcinoma HPO 0.20
Name (Synonyms) Correlation
HP:0002664 Neoplasm HPO 0.11

Clinical Trials

Navigate: Correlations   HPO

There are 3 clinical trials


1 A Phase 1b, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) as Monotherapy or in Combination in Patients With Selected Advanced Solid Tumors

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.

NCT03621982
Conditions
  1. Advanced Solid Tumors With Literature Evidence of CD25(+) Treg Content
  2. Head and Neck Cancer Squamous Cell Carcinoma
  3. Non-small Cell Lung Cancer
  4. Gastric Cancer
  5. Esophageal Cancer
  6. Pancreas Cancer
  7. Bladder Cancer
  8. Renal Cell Carcinoma
  9. Melanoma
  10. Triple-negative Breast Cancer
  11. Ovarian Cancer
  12. Colo-rectal Cancer
Interventions
  1. Drug: ADCT-301
  2. Biological: Pembrolizumab
MeSH:Carcinoma Carcinoma, Renal Cell Triple Negative Breast Neoplasms Pancreatic Neoplasms
HPO:Carcinoma Clear cell renal cell carcinoma Neoplasm of the pancreas Papillary renal cell carcinoma Renal cell carcinoma

Primary Outcomes

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 years

Description: 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 years

Description: 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 years

Description: 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 years

Measure: Number of Dose Interruptions and/or Dose Reductions

Time: Up to 3 years

Measure: Number of Dose Limiting Toxicities

Time: Up to 3 years

Measure: Number of Participants who Experience a Clinically Significant Change in Baseline in Laboratory Values

Time: Up to 3 years

Measure: Number of Participants who Experience a Clinically Significant Change in Baseline in Vital Signs

Time: Up to 3 years

Measure: Number of Participants who Experience a Clinically Significant Change in Baseline in Electrocardiogram (ECG) Results

Time: Up to 3 years

Measure: Number of Particpants who Experience a Clinically Significant Change in Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status

Time: Up to 3 years

Secondary Outcomes

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

Description: Noncompartmental analysis of the time to maximum concentration (Tmax)

Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum

Time: Up to 3 years

Description: 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 years

Description: 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 years

Description: 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 years

Description: Noncompartmental analysis of the accumulation index (AI)

Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum

Time: Up to 3 years

Description: Noncompartmental analysis of clearance (CL)

Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum

Time: Up to 3 years

Description: Noncompartmental analysis of volume of distribution (Vd)

Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum

Time: Up to 3 years

Description: 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 years
2 A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors

The 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.

NCT03729596
Conditions
  1. Advanced Solid Tumor, Adult
  2. Metastatic Castrate Resistant Prostate Cancer
  3. Non Small Cell Lung Cancer
  4. Triple Negative Breast Cancer
Interventions
  1. Biological: MGC018
  2. Biological: MGA012
MeSH:Prostatic Neoplasms Triple Negative Breast Neoplasms
HPO:Prostate cancer Prostate neoplasm

Primary Outcomes

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 dose

Description: Maximum tolerated or maximum administered dose of MGC018 and MGC018 + MGA012

Measure: Maximum Tolerated Dose

Time: up to 42 days from first dose

Secondary Outcomes

Description: 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 months

Description: Percent of prostate cancer patients with at least 50% reduction in prostate-specific antigen (PSA)

Measure: PSA response rate

Time: 24 months

Description: 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 months

Description: 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 months

Description: Area under the plasma concentration versus time curve of MGC018 and MGC018+MGA012

Measure: Area under the curve

Time: 24 months

Description: Maximum Plasma Concentration of MGC018 and MGC018+MGA012

Measure: Cmax

Time: 24 months

Description: Time to reach maximum (peak) plasma concentration of MGC018 and MGC018+MGA012

Measure: Tmax

Time: 24 months

Description: Trough plasma concentration of MGC018 and MGC018+MGA012

Measure: Ctrough

Time: 24 months

Description: Total body clearance of the drug from plasma of MGC018 and MGC018+MGA012

Measure: CL

Time: 24 months

Description: Apparent volume of distribution at steady state of MGC018 and MGC018+MGA012

Measure: Vss

Time: 24 months

Description: Terminal half life of MGC018 and MGC018+MGA012

Measure: t1/2

Time: 24 months

Description: Percent of patients with anti-drug antibodies against MGC018 and MGA012

Measure: Immunogenicity

Time: 24 months
3 PHASE 1/2A DOSE ESCALATION, FINDING AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY

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.

NCT04553133
Conditions
  1. Small Cell Lung Cancer
  2. Ovarian Cancer
  3. Triple Negative Breast Cancer
  4. Non-small Cell Lung Cancer
  5. Human Receptor-positive Human Epidermal Growth Factor Receptor 2
Interventions
  1. Drug: PF-07104091 monotherapy
  2. Drug: PF-07104091 + palbociclib
  3. Drug: PF-07104091 + palbociclib + letrozole
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung Ovarian Neoplasms Small Cell Lung Carcinoma Triple Negative Breast Neoplasms
HPO:Neoplasm of the lung Non-small cell lung carcinoma Ovarian neoplasm Small cell lung carcinoma

Primary Outcomes

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 days

Description: 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)

Secondary Outcomes

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)

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

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.

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