Trial · NCT03433898
This Study Aims to Find a Safe and Effective Dose of BI 754091. The Study Also Aims to Find Safe and Effective Doses of BI 754091 and BI 754111 in Combination. This Study is Done in Asian Patients With Different Types of Cancer
NCT03433898, Early phase 1, Completed, Boehringer Ingelheim; results first posted 2025-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. This Study Aims to Find a Safe and Effective Dose of BI 754091. The Study Also Aims to Find Safe and Effective Doses of BI 754091 and BI 754111 in Combination. This Study is Done in Asian Patients With Different Types of Cancer. Trials, record NCT03433898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03433898
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
This Study Aims to Find a Safe and Effective Dose of BI 754091. The Study Also Aims to Find Safe and Effective Doses of BI 754091 and BI 754111 in Combination. This Study is Done in Asian Patients With Different Types of Cancer
- NCT number
- NCT03433898
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 146 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Neoplasms
- Interventions
- Ezabenlimab, BI 754111
- First posted
- 2018-02-15
- Last updated
- 2025-12-19
- Results first posted
- 2025-12-19
- Limitations and caveats
A Cohort E in part III, composed of first line non-small cell lung cancer patients, was also originally planned. However, the clinical development of the combination therapy of BI 754111 and ezabenlimab was concluded early according to protocol due to lack of efficacy of BI 754111 before Cohort E was initiated, so no patient was enrolled in the cohort.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part I: Maximum Tolerated Dose (MTD) of Ezabenlimab | Part I - ezabenlimab 240 mg | NA | Milligram | ||
| Part I: Number of Patients Experiencing DLTs During the MTD Evaluation Period (First Cycle of Treatment) | Part I - ezabenlimab 240 mg | 0 | Participants | ||
| Part II: MTD of the Ezabenlimab Plus BI 754111 Combination Therapy | Part II - ezabenlimab 240 mg + multiple BI 754111 doses | NA | Milligram | ||
| Part II: Number of Patients Experiencing DLTs During the MTD Evaluation Period (First Cycle of Treatment) | Part II - ezabenlimab 240 mg + BI 754111 400 mg | 0 | Participants | ||
| Part II: Number of Patients Experiencing DLTs During the MTD Evaluation Period (First Cycle of Treatment) | Part II - ezabenlimab 240 mg + BI 754111 600 mg | 0 | Participants | ||
| Part II: Number of Patients Experiencing DLTs During the MTD Evaluation Period (First Cycle of Treatment) | Part II - ezabenlimab 240 mg + BI 754111 800 mg | 0 | Participants | ||
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 | Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort A | 4 | Participants | ||
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 | Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort B | 8 | Participants | ||
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 | Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort C | 0 | Participants | ||
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 | Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort D | 2 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part I - ezabenlimab 240 mg | 7 | |
| Overall Study | STARTED | Part II - ezabenlimab 240 mg + BI 754111 400 mg | 3 | |
| Overall Study | STARTED | Part II - ezabenlimab 240 mg + BI 754111 600 mg | 3 | |
| Overall Study | STARTED | Part II - ezabenlimab 240 mg + BI 754111 800 mg | 3 | |
| Overall Study | STARTED | Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort A | 37 | |
| Overall Study | STARTED | Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort B | 37 | |
| Overall Study | STARTED | Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort C | 20 | |
| Overall Study | STARTED | Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort D | 36 | |
| Overall Study | Treated | Part I - ezabenlimab 240 mg | 6 | |
| Overall Study | Treated | Part II - ezabenlimab 240 mg + BI 754111 400 mg | 3 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events480
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part I - ezabenlimab 240 mg | 2 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Part II - ezabenlimab 240 mg + BI 754111 400 mg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part II - ezabenlimab 240 mg + BI 754111 600 mg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part II - ezabenlimab 240 mg + BI 754111 800 mg | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part III - ezabenlimab 240 mg + BI 754111 600 mg | 18 | 129 | |
| other | Hypothyroidism | Endocrine disorders | Part I - ezabenlimab 240 mg | 0 | 6 | |
| other | Hypothyroidism | Endocrine disorders | Part II - ezabenlimab 240 mg + BI 754111 400 mg | 2 | 3 | |
| other | Hypothyroidism | Endocrine disorders | Part II - ezabenlimab 240 mg + BI 754111 600 mg | 0 | 3 | |
| other | Hypothyroidism | Endocrine disorders | Part II - ezabenlimab 240 mg + BI 754111 800 mg | 0 | 3 | |
| other | Hypothyroidism | Endocrine disorders | Part III - ezabenlimab 240 mg + BI 754111 600 mg | 11 | 129 |
1 to 10 of 480Source ClinicalTrials.gov
See all 480 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part I - ezabenlimab 240 mg | 0 | 6 |
| Total, all-cause mortality | Part II - ezabenlimab 240 mg + BI 754111 400 mg | 0 | 3 |
| Total, all-cause mortality | Part II - ezabenlimab 240 mg + BI 754111 600 mg | 0 | 3 |
| Total, all-cause mortality | Part II - ezabenlimab 240 mg + BI 754111 800 mg | 0 | 3 |
| Total, all-cause mortality | Part III - ezabenlimab 240 mg + BI 754111 600 mg | 3 | 129 |
| Total, other adverse events | Part I - ezabenlimab 240 mg | 6 | 6 |
| Total, other adverse events | Part II - ezabenlimab 240 mg + BI 754111 400 mg | 3 | 3 |
| Total, other adverse events | Part II - ezabenlimab 240 mg + BI 754111 600 mg | 3 | 3 |
| Total, other adverse events | Part II - ezabenlimab 240 mg + BI 754111 800 mg | 3 | 3 |
| Total, other adverse events | Part III - ezabenlimab 240 mg + BI 754111 600 mg | 100 | 129 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35756842 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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