Trial · NCT03433898
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part I: Maximum Tolerated Dose (MTD) of Ezabenlimab | First cycle of treatment: 3 weeks (21 days) following drug administration. | Maximum tolerated dose set (MTDS) restricted to Part I: included all patients who were documented to have received at least one dose of ezabenlimab in Part I and were not replaced for the MTD determination. Patients who discontinued during the first treatment course for reasons other than a DLT were excluded from the determination of the MTD. The MTDS was used for the primary analyses of DLTs and MTD determination. | Milligram | NUMBER |
| 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. | Maximum tolerated dose set (MTDS) restricted to Part I: included all patients who were documented to have received at least one dose of ezabenlimab in Part I and were not replaced for the MTD determination. Patients who discontinued during the first treatment course for reasons other than a DLT were excluded from the determination of the MTD. The MTDS was used for the primary analyses of DLTs and MTD determination. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part II: MTD of the Ezabenlimab Plus BI 754111 Combination Therapy | First cycle of treatment: 3 weeks (21 days) following drug administration. | Maximum tolerated dose set (MTDS) restricted to Part II: included all patients who were documented to have received at least one dose of ezabenlimab or BI 754111 in Part II and were not replaced for the MTD determination. Patients who discontinued during the first treatment course for reasons other than a DLT were excluded from the determination of the MTD. The MTDS was used for the primary analyses of DLTs and MTD determination. | Milligram | NUMBER |
| 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. | Maximum tolerated dose set (MTDS) restricted to Part II: included all patients who were documented to have received at least one dose of ezabenlimab or BI 754111 in Part II and were not replaced for the MTD determination. Patients who discontinued during the first treatment course for reasons other than a DLT were excluded from the determination of the MTD. The MTDS was used for the primary analyses of DLTs and MTD determination. | Participants | COUNT_OF_PARTICIPANTS |
| 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. | Treated set (TS) restricted to Part III: included all Part III patients who were documented to have received at least one dose of ezabenlimab or BI 754111. The TS was used for both efficacy and safety analyses. Patients with a post baseline measurement are reported here. | Participants | COUNT_OF_PARTICIPANTS |
| 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. | Treated set (TS) restricted to Part III: included all Part III patients who were documented to have received at least one dose of ezabenlimab or BI 754111. The TS was used for both efficacy and safety analyses. Patients who had a confirmed or unconfirmed objective response are reported here. | Days | MEDIAN |
| 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. | Treated set (TS) restricted to Part III: included all Part III patients who were documented to have received at least one dose of ezabenlimab or BI 754111. The TS was used for both efficacy and safety analyses. Patients who had a post baseline measurement are reported here. | Participants | COUNT_OF_PARTICIPANTS |
| 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. | Treated set (TS) restricted to Part I: included all Part I patients who were documented to have received at least one dose of ezabenlimab or BI 754111. The TS was used for both efficacy and safety analyses. Patients who had a post baseline measurement are reported here. | Participants | COUNT_OF_PARTICIPANTS |
| 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. | Treated set (TS) restricted to Part II: included all Part II patients who were documented to have received at least one dose of ezabenlimab or BI 754111. The TS was used for both efficacy and safety analyses. Patients who had a post baseline measurement are reported here. | Participants | COUNT_OF_PARTICIPANTS |
| 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. | Pharmacokinetic (PK) analysis set (PKS) restricted to Part I: included all Part I patients in the TS who provided at least one evaluable observation for at least one pharmacokinetic endpoint and no pharmacokinetic relevant protocol deviation. The PKS was used for statistical pharmacokinetic analysis. | microgram/milliliter | GEOMETRIC_MEAN |
| 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. | Pharmacokinetic (PK) analysis set (PKS) restricted to Part II: included all Part II patients in the TS who provided at least one evaluable observation for at least one pharmacokinetic endpoint and no pharmacokinetic relevant protocol deviation. The PKS was used for statistical pharmacokinetic analysis. | microgram/milliliter | GEOMETRIC_MEAN |
| 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. | Pharmacokinetic (PK) analysis set (PKS) restricted to Part II: included all Part II patients in the TS who provided at least one evaluable observation for at least one pharmacokinetic endpoint and no pharmacokinetic relevant protocol deviation. The PKS was used for statistical pharmacokinetic analysis. | microgram/milliliter | GEOMETRIC_MEAN |
| 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. | Pharmacokinetic (PK) analysis set (PKS) restricted to Part I: included all Part I patients in the TS who provided at least one evaluable observation for at least one pharmacokinetic endpoint and no pharmacokinetic relevant protocol deviation. The PKS was used for statistical pharmacokinetic analysis. | hour*microgram/milliliter | GEOMETRIC_MEAN |
| 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. | Pharmacokinetic (PK) analysis set (PKS) restricted to Part II: included all Part II patients in the TS who provided at least one evaluable observation for at least one pharmacokinetic endpoint and no pharmacokinetic relevant protocol deviation. The PKS was used for statistical pharmacokinetic analysis. | hour*microgram/milliliter | GEOMETRIC_MEAN |
| 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. | Pharmacokinetic (PK) analysis set (PKS) restricted to Part II: included all Part II patients in the TS who provided at least one evaluable observation for at least one pharmacokinetic endpoint and no pharmacokinetic relevant protocol deviation. The PKS was used for statistical pharmacokinetic analysis. | hour*microgram/milliliter | GEOMETRIC_MEAN |
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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