Trial · NCT03433898
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part I: Maximum Tolerated Dose (MTD) of Ezabenlimab | First cycle of treatment: 3 weeks (21 days) following drug administration. | MTD is defined as the highest dose for a given schedule expected to cause \<25% risk of the true dose limiting toxicity (DLT) rate being ≥33% during the MTD evaluation period. Haematologic DLTs: any Grade 5 toxicity; neutropenia ≥Grade 4 for \>5 days; any duration Febrile neutropenia; grade 4 thrombocytopenia or Grade 3 with bleeding or requiring platelet transfusions (any Grade); unexplained Grade 4 anaemia or requiring blood transfusions (any Grade). Non-haematological DLTs: aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>3x Upper limit of normal (ULN) and total bilirubin \>2x ULN without cholestasis signs; any duration ≥Grade 4 AST or ALT; any ≥Grade 3 non-haematologic toxicity with exceptions; any Grade 4 or 5 adverse event; any duration any Grade 2 pneumonitis; any Grade 2 uveitis, eye pain, or blurred vision not improving to Grade 1 within 2 weeks or requiring systemic treatment; any ≥Grade 2 toxicity causing inability to administer trial drug on Cycle 2 Day 1. |
| Primary | Part I: Number of Patients Experiencing DLTs During the MTD Evaluation Period (First Cycle of Treatment) | First cycle of treatment: 3 weeks (21 days) following drug administration. | Number of patients experiencing DLTs during the MTD evaluation period (first cycle of treatment) is reported. |
| Primary | Part II: MTD of the Ezabenlimab Plus BI 754111 Combination Therapy | First cycle of treatment: 3 weeks (21 days) following drug administration. | MTD is defined as the highest dose for a given schedule expected to cause \<25% risk of the true DLT rate being ≥33% during the MTD evaluation period. Haematologic DLTs: any Grade 5 toxicity; neutropenia ≥Grade 4 for \>5 days; any duration Febrile neutropenia; grade 4 thrombocytopenia or Grade 3 with bleeding or requiring platelet transfusions (any Grade); unexplained Grade 4 anaemia or requiring blood transfusions (any Grade). Non-haematological DLTs: aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>3x Upper limit of normal (ULN) and total bilirubin \>2x ULN without cholestasis signs; any duration ≥Grade 4 AST or ALT; any ≥Grade 3 non-haematologic toxicity with exceptions; any Grade 4 or 5 adverse event; any duration any Grade 2 pneumonitis; any Grade 2 uveitis, eye pain, or blurred vision not improving to Grade 1 within 2 weeks or requiring systemic treatment; any ≥Grade 2 toxicity causing inability to administer trial drugs on Cycle 2 Day 1. |
| Primary | Part II: Number of Patients Experiencing DLTs During the MTD Evaluation Period (First Cycle of Treatment) | First cycle of treatment: 3 weeks (21 days) following drug administration. | Number of patients experiencing DLTs during the MTD evaluation period (first cycle of treatment) is reported. |
| Primary | Part III: Number of Patients With Objective Response (OR) - Confirmed Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 as Assessed by the Investigator | From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period): up to 49 months. | Number of patients with objective response (OR) - confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumours (RECIST) Version 1.1 as assessed by the Investigator, is reported. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Part III: Duration of Response | From the date of objective response until first date that death or PD has been documented, up to 1362 days. | The duration of response, defined as the interval from the date of first documented PR or CR according to RECIST Version 1.1 as assessed by the Investigator, to the date of progressive disease (PD) or death, is reported. For all patients with an OR, the duration of OR was calculated as follows: * for patients with PD or death: duration of response \[days\] = date of outcome - date of first assessment indicating OR + 1, * for patients without PD or death: duration of response (censored) \[days\] = date of outcome - date of first assessment indicating OR + 1, for patients without disease progression or death. Kaplan-Meier estimates were used to calculate median duration of OR. |
| Secondary | Part III: Number of Patients With Disease Control | From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period): up to 49 months. | Number of patients with disease control is reported. Disease control: CR, PR, or stable disease (SD) according to RECIST Version 1.1 as assessed by the Investigator. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Part I: Number of Patients With OR: Confirmed CR or PR According to RECIST v1.1 as Assessed by the Investigator | From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period): 180 days. | Number of patients with OR: confirmed CR or PR according to RECIST v1.1 as assessed by the Investigator, is reported. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Part II: Number of Patients With OR: Confirmed CR or PR According to RECIST v1.1 as Assessed by the Investigator | From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period): up to 389 days. | Number of patients with OR: confirmed CR or PR according to RECIST v1.1 as assessed by the Investigator, is reported. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Part I: Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) in the First Cycle of Treatment | 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment. | Maximum measured concentration of ezabenlimab in plasma (Cmax) in the first cycle of treatment (21 days following drug administration) is reported. |
| Secondary | Part II: Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) in the First Cycle of Treatment | 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment. | Maximum measured concentration of ezabenlimab in plasma (Cmax) in the first cycle of treatment (21 days following drug administration) is reported. |
| Secondary | Part II: Maximum Measured Concentration of BI 754111 in Plasma (Cmax) in the First Cycle of Treatment | 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment. | Maximum measured concentration of BI 754111 in plasma (Cmax) in the first cycle of treatment (21 days following drug administration) is reported. |
| Secondary | Part I: Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504) in the First Cycle of Treatment | 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment. | Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504) in the first cycle of treatment (21 days following drug administration) is reported. |
| Secondary | Part II: Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504) in the First Cycle of Treatment | 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment. | Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504) in the first cycle of treatment (21 days following drug administration) is reported. |
| Secondary | Part II: Area Under the Concentration-time Curve of BI 754111 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504) in the First Cycle of Treatment | 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment. | Area under the concentration-time curve of BI 754111 in plasma over the time interval from 0 to 504 hours (AUC0-504) in the first cycle of treatment (21 days following drug administration) is reported. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03433898/registered