Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002945-31 | EudraCT Number |
Not provided
Not provided
Not provided
Sponsor decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is open to adults with different types of advanced cancer (solid tumours). This study is open to people in whom previous treatments were not successful. The purpose of this study is to find out the highest dose of BI 905677 the participants can tolerate. BI 905677 is a type of an antibody that is being developed to treat cancer.
One dose of BI 905677 is given to the participants every 2 or 3 weeks as infusion into a vein. In this study, BI 905677 is given to humans for the first time. The participants visit the study site at least once a week so that the doctors can check their general health. The participants are in the study for as long as they benefit from and can tolerate treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 905677 0.05 mg/kg | Experimental | 0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
|
| BI 905677 0.1 mg/kg | Experimental | 0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
|
| BI 905677 0.2 mg/kg | Experimental | 0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
|
| BI 905677 0.4 mg/kg | Experimental | 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 905677 | Drug | Solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | The number of participants with Dose Limiting Toxicities (DLTs) is reported. Any of the following adverse events (AEs) will be classified as DLTs following review by the Safety Monitoring Committee and the Medical Monitor, unless unequivocally due to underlying malignancy or an extraneous cause, including any AE which prevents a patient starting Cycle 2 within 14 days of completion of Cycle 1; Bone mineral density change of >5% from baseline, confirmed at least 2 months after initial observation; β-CTX increase of more than two-fold from baseline; Grade 3 osteoporosis, and so on. | In the first treatment cycle, up to 3 weeks |
| Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period | The Number of patients experiencing adverse events (AEs) during the entire treatment period is reported. | From first dose until last dose + 42 days (6 weeks) of residual effect period, up to 36 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax) | The Maximum measured concentration of BI 905677 in serum after first infusion is reported. | 5 minutes (min) before and at 1, 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1. |
| Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz) |
Not provided
Inclusion criteria
Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must have measurable or evaluable lesions (according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1).
Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted treatment options known to prolong survival for their disease.
Patient willing to undergo mandatory skin biopsy at the timepoints specified in the protocol.
Eastern Cooperative Oncology Group score of 0 or 1.
Adequate organ function defined as all of the following:
Recovered from any previous therapy-related toxicity to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at start of treatment (except for alopecia and stable sensory neuropathy which must be ≤ CTCAE Grade 2).
At least 18 years of age at the time of consent or over the legal age of consent in countries where that is greater than 18 years.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Life expectancy ≥ 3 months at the start of treatment in the opinion of the investigator.
Male or female patients. Women of childbearing potential (WOCBP) must only be included after a confirmed menstrual period within the past 4 weeks and a negative pregnancy test at screening. WOCBP with irregular menstruation may be included after two negative pregnancy tests during screening between 2 and 4 weeks apart. WOCBP and men who are able to father a child must be ready and able to use highly effective methods of birth control, per ICH M3 (R2), that result in a low failure rate of less than 1% per year when used consistently and correctly. These methods must be used during the study and for at least 6 months after the last dose of BI 905677. A list of contraception methods meeting these criteria is provided in the patient information.
Exclusion criteria
Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first trial treatment or planned within 6 months after screening.
Previous or concomitant malignancies other than the one treated in this trial within the last 2 years, except;
Osteoporosis ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
Chronic corticosteroid use
Osteoporotic compression fracture within 12 months prior to informed consent which is clinically significant in the opinion of the investigator.
Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Previous treatment in this trial.
Treatment with a systemic anti-cancer therapy or investigational drug within 28 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication.
Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the safety and efficacy of the test drug.
Women who are pregnant, nursing, or who plan to become pregnant or nurse during the trial or within 6 months after the last dose of study treatment.
Active alcohol or drug abuse in the opinion of the investigator.
Patient unwilling or unable to comply with the protocol.
Presence or history of uncontrolled or symptomatic brain or subdural metastases, unless considered stable by the investigator and local therapy was completed. Inclusion of patients with newly identified brain metastasis/es at screening will be allowed if patients are asymptomatic.
Known history of human immunodeficiency virus (HIV) infection or an active hepatitis B or C infection which in the opinion of the investigator may interfere with participation in the trial.
History of severe hypersensitivity reactions to monoclonal antibodies.
History of allergy to kanamycin or similar class drugs (including streptomycin, gentamicin, amikacin, tobramycin and neomycin).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Memorial Sloan-Kettering Cancer Center |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
For more details refer to: https://www.mystudywindow.com/msw/datasharing
Not provided
Not provided
Not provided
Not provided
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This non-randomised, open-label, single arm, dose escalation trial was planned to determine the maximum tolerated dose (MTD) of BI 905677 given as an intravenous infusion and to determine the recommended dose and dosing schedule for further trials in the development of BI 905677. Two treatment schedules (A and B) were planned. But only Schedule A was conducted.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BI 905677 0.05 mg/kg | 0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| FG001 | BI 905677 0.1 mg/kg | 0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| FG002 | BI 905677 0.2 mg/kg | 0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| FG003 | BI 905677 0.4 mg/kg | 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| FG004 | BI 905677 0.8 mg/kg | 0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| FG005 | BI 905677 1.6 mg/kg | 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| FG006 | BI 905677 2.4 mg/kg | 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| FG007 | BI 905677 2.8 mg/kg | 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| FG008 | BI 905677 3.6 mg/kg | 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BI 905677 0.05 mg/kg | 0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | The number of participants with Dose Limiting Toxicities (DLTs) is reported. Any of the following adverse events (AEs) will be classified as DLTs following review by the Safety Monitoring Committee and the Medical Monitor, unless unequivocally due to underlying malignancy or an extraneous cause, including any AE which prevents a patient starting Cycle 2 within 14 days of completion of Cycle 1; Bone mineral density change of >5% from baseline, confirmed at least 2 months after initial observation; β-CTX increase of more than two-fold from baseline; Grade 3 osteoporosis, and so on. | Maximum Tolerated Dose (MTD) Evaluation Set (MTDS): includes all patients in the treated set who were not replaced for the MTD determination. | Posted | Count of Participants | Participants | In the first treatment cycle, up to 3 weeks |
|
For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months.
Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BI 905677 0.05 mg/kg | 0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
Recruitment into Schedule B was planned start after the maximum tolerated dose of Schedule A was reached. Study was terminated prematurely due to sponsor decision before Schedule B starting. The planned Schedule B part was not held.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 18002430127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 2, 2018 | Jul 21, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2022 | Jul 21, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BI 905677 0.8 mg/kg |
| Experimental |
0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
|
| BI 905677 1.6 mg/kg | Experimental | 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
|
| BI 905677 2.4 mg/kg | Experimental | 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
|
| BI 905677 2.8 mg/kg | Experimental | 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
|
| BI 905677 3.6 mg/kg | Experimental | 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
|
The Area under the serum concentration-time curve over the time interval from 0 to the last measured time point is reported. |
| 5 minutes (min) before and at 1 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1. |
| New York |
| New York |
| 10065 |
| United States |
| National Cancer Center Hospital East | Chiba, Kashiwa | 277-8577 | Japan |
| Erasmus MC Kanker Instituut | Rotterdam | 3015 CN | Netherlands |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Withdrawal by Subject |
|
| Missing visit |
|
| Adverse Event |
|
| BI 905677 0.1 mg/kg |
0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| BG002 | BI 905677 0.2 mg/kg | 0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| BG003 | BI 905677 0.4 mg/kg | 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| BG004 | BI 905677 0.8 mg/kg | 0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| BG005 | BI 905677 1.6 mg/kg | 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| BG006 | BI 905677 2.4 mg/kg | 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| BG007 | BI 905677 2.8 mg/kg | 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| BG008 | BI 905677 3.6 mg/kg | 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| BG009 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.
| OG001 | BI 905677 0.1 mg/kg | 0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| OG002 | BI 905677 0.2 mg/kg | 0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| OG003 | BI 905677 0.4 mg/kg | 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| OG004 | BI 905677 0.8 mg/kg | 0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| OG005 | BI 905677 1.6 mg/kg | 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| OG006 | BI 905677 2.4 mg/kg | 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| OG007 | BI 905677 2.8 mg/kg | 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
| OG008 | BI 905677 3.6 mg/kg | 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. |
|
|
|
| Primary | Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period | The Number of patients experiencing adverse events (AEs) during the entire treatment period is reported. | Treated Set (TS): includes all patients who received at least one infusion of BI 905677. | Posted | Count of Participants | Participants | From first dose until last dose + 42 days (6 weeks) of residual effect period, up to 36 weeks. |
|
|
|
| Secondary | Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax) | The Maximum measured concentration of BI 905677 in serum after first infusion is reported. | Pharmacokinetics (PK) Analysis Set (PKS): The PK set included all patients in the treated set who provided at least one observation for at least one PK endpoint without important protocol violations relevant to the evaluation of PK. Only participants with non-missing outcomes were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram / milliliter | 5 minutes (min) before and at 1, 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1. |
|
|
|
| Secondary | Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz) | The Area under the serum concentration-time curve over the time interval from 0 to the last measured time point is reported. | Pharmacokinetics (PK) Analysis Set (PKS): The PK set included all patients in the treated set who provided at least one observation for at least one PK endpoint without important protocol violations relevant to the evaluation of PK. Only participants with non-missing outcomes were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram * hour / milliliter | 5 minutes (min) before and at 1 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1. |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | BI 905677 0.1 mg/kg | 0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 1 | 3 | 2 | 3 | 3 | 3 |
| EG002 | BI 905677 0.2 mg/kg | 0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 0 | 3 | 1 | 3 | 2 | 3 |
| EG003 | BI 905677 0.4 mg/kg | 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 1 | 3 | 2 | 3 | 3 | 3 |
| EG004 | BI 905677 0.8 mg/kg | 0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG005 | BI 905677 1.6 mg/kg | 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 0 | 6 | 2 | 6 | 6 | 6 |
| EG006 | BI 905677 2.4 mg/kg | 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 2 | 6 | 4 | 6 | 6 | 6 |
| EG007 | BI 905677 2.8 mg/kg | 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 1 | 7 | 7 | 7 | 7 | 7 |
| EG008 | BI 905677 3.6 mg/kg | 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 1 | 3 | 3 | 3 | 3 | 3 |
| Vertigo | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Biliary obstruction | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Klebsiella sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Stoma site infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Blood electrolytes decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| C-telopeptide increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Vena cava thrombosis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood bicarbonate decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Bone density decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| C-telopeptide increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypotriglyceridaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Genital pain | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
|
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.