Trial · NCT04394624
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Doublet Cohort - Part 1: Number of Participants With Study Drug-Related Dose-Limiting Toxicity (DLT) | From Cycle 1 Day 1 up to Cycle 2 Day 14, approximately 28 days | The following AEs occurred during the first 2 cycles of treatment, unless due to disease progression or to a cause obviously unrelated to study drug, were considered DLTs: • Grade 4 neutropenia for 7 or more consecutive days. • Grade 3 to 4 neutropenia complicated by fever. • Grade \>=3 thrombocytopenia. • Elevated urine protein \>=3 gram(g)/24 hour. • Grade 4 non-hematologic AE. • Grade \>=3 keratopathy. • Grade 4 or refractory hypertension. In addition, any other AE that the Investigators and sponsor deemed to be dose limiting, regardless of its grade, was also considered as DLT. |
| Primary | Doublet Cohort - Part 2: Objective Response Rate (ORR) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 130 weeks | The ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) as best overall response (BOR) determined per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The CR is defined as disappearance of all target lesions. The PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Primary | Triplet Cohort: Number of Participants With Study Drug-Related Dose-Limiting Toxicity | From Cycle 1 Day 1 up to Cycle 1 Day 21 | The following AEs occurred during the first cycle of treatment, unless due to disease progression or to a cause obviously unrelated to study drug, were considered DLTs: • Grade 4 neutropenia for 7 or more consecutive days. • Grade 3 to 4 neutropenia complicated by fever. • Grade \>=3 thrombocytopenia. • Elevated urine protein \>=3 g/24 hour. • Grade 4 non-hematologic AE. • Grade \>=3 keratopathy. • Grade 4 or refractory hypertension. In addition, any other AE that the Investigators and sponsor deemed dose limiting, regardless of its grade, was also considered as DLT. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or congenital anomaly/birth defect. TEAE is defined as AEs that develop, worsen, or become serious during the treatment period. |
| Secondary | Number of Participants With Potentially Clinically Significant Abnormalities: Hematology | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | Blood samples were collected to determine the hematology laboratory clinically significant abnormalities. |
| Secondary | Number of Participants With Potentially Clinically Significant Abnormalities: Metabolism | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | Blood samples were collected to determine the clinically significant abnormalities in metabolism. |
| Secondary | Number of Participants With Potentially Clinically Significant Abnormalities: Electrolytes | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | Blood samples were collected to determine the clinically significant abnormalities in electrolytes. |
| Secondary | Number of Participants With Potentially Clinically Significant Abnormalities: Renal Function | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | Blood samples were collected to determine the renal function laboratory clinically significant abnormalities. |
| Secondary | Number of Participants With Potentially Clinically Significant Abnormalities: Liver Function | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | Blood samples were collected to determine the liver function laboratory clinically significant abnormalities. |
| Secondary | Number of Participants With Potentially Clinically Significant Abnormalities: Electrocardiogram (ECG) | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | A single 12-lead ECG was recorded using an ECG machine that automatically calculates the heart rate and measures PR, QRS, and QT intervals. |
| Secondary | Number of Participants With Potentially Clinically Significant Abnormalities: Urinalysis | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | Urine samples were collected to determine the clinically significant abnormalities in urine. |
| Secondary | Doublet Cohort: Duration of Response (DOR) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 130 weeks | The DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST v1.1 or death from any cause, whichever occurs first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. |
| Secondary | Doublet Cohort: Progression-Free Survival (PFS) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 130 weeks | The PFS is defined as the time from the first study drug administration to the date of the first documented disease progression or death due to any cause, whichever comes first. |
| Secondary | Doublet Cohort: Disease Control Rate (DCR) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 130 weeks | The DCR is defined as the percentage of participants who achieved confirmed CR, confirmed PR or stable disease (SD) as per RECIST v1.1. The SD is defined as neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Triplet Cohort: Objective Response Rate | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 130 weeks | The ORR is defined as percentage of participants with confirmed CR or PR as BOR determined per RECIST v1.1. |
| Secondary | Doublet Cohort: Maximum Observed Concentration (Cmax) of Tusamitamab Ravtansine | Day 1 of Cycles 1 and 4 | Blood samples were collected for the measurement of Cmax of tusamitamab ravtansine concentrations. Cmax of tusamitamab ravtansine was calculated using non-compartmental method. |
| Secondary | Doublet Cohort: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 14 Days (AUC0-14d) of Tusamitamab Ravtansine | Day 1 of Cycles 1 and 4 | Blood samples were collected for the measurement of AUC0-14d of tusamitamab ravtansine concentrations. AUC0-14d was calculated using the trapezoidal method from time 0 to 14 days and non-compartmental method. |
| Secondary | Doublet Cohort: Concentration Observed Before Treatment Administration During Repeated Dosing (Ctrough) of Ramucirumab | Cycle 2 Day 1 | Blood samples were collected for the measurement of Ctrough of ramucirumab concentrations. Ctrough was calculated using non-compartmental method. |
| Secondary | Number of Participants With Anti-Therapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | Blood samples were collected to assess the presence of ATA against tusamitamab ravtansine in plasma from all participants. Treatment-emergent ATA is defined as participant with at least 1 treatment-induced/boosted ATA during the treatment period. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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