Phase I, first in human trial two BI IMPs in advanced or solid tumours
Research type
Research Study
Full title
Phase I, first in human trial evaluating BI 1387446 alone and in combination with BI 754091 in solid tumors.
IRAS ID
268974
Contact name
Kevin Harrington
Contact email
Eudract number
2019-001082-32
Duration of Study in the UK
3 years, 8 months, 17 days
Research summary
Research Summary
This study is a phase I, to characterise the safety and to determine the maximum tolerated dose (MTD) for BI 1387446 in combination with BI 754091 in solid tumors.
Patients will undergo screening assessment to confirm their eligibility to participate. Patients will receive either BI 1387446 as single agent (Arm A) or BI 1387446 in combination with BI 754091 (Arm B and Arm C) as described in table 4.1.2.3:1 for Arm A table 4.1.2.3:2 for Arm B and table 4.1.2.3:3 for Arm C. All treatments will be administered in cycles 21 days duration. Patients will continue treatment with the study drugs until progressive disease (PD) by response evaluation criteria in solid tumours (RECIST), withdrawal of patient consent, an unacceptable toxicity occurs, or the maximum number of cycles of treatment are reached, whichever occurs first.
Summary of Results
Study title: A study to find the best dose of BI 1387446 alone or in combination with ezabenlimab (BI 754091) in patients with different types of advanced or metastatic cancer (solid tumours)
This is a summary of results from 1 clinical study.
We thank all study participants. You helped us to answer important questions about BI 1387446 and the treatment of different types of advanced or metastatic cancer.
What was this study about?
The purpose of this study was to find the highest dose of a medicine called BI 1387446 that people with advanced or metastatic cancer could tolerate when taken alone and together with a medicine called ezabenlimab.
Who took part in this study?
38 people took part in this study, in 2 Parts (Part A and Part B). In Part A, there were 15 men (58%) and 11 women (42%). In Part B, there were 10 men (62%) and 6 women (38%). 4 participants participated in both parts.
In Part A, the youngest participant was 21 years old, and the oldest participant was 82 years old. The average age was 60 years.
In Part B, the youngest participant was 21 years old, and the oldest participant was 76 years old. The average age was 51 years.
Participants were from 3 different backgrounds.
Part A: White (92%), Asian (4%), Native Hawaiian or other Pacific (4%)
Part B: White (100%)
How was this study done?
The study was divided in 2 parts.
Part A:
The participants received 4 different doses of BI 1387446. The first participants received a low dose and participants who started the study later received higher doses, if the lower doses were well tolerated. Participants received 1 dose of BI 1387446, every week at the beginning and then every 3 weeks.
Participants received between 50 μg and 400 μg of BI 1387446 injected into the tumour. The participants and doctors knew which dose each participant was receiving.
The researchers wanted to find the highest dose of BI 1387446 participants could tolerate. To find out, the researchers looked at the number of participants with certain severe health problems (unwanted effects) that the doctors think are caused by the study medicine, which limited any further increase in the dose.
Part B:
Participants received 3 different doses of BI 1387446 in combination with ezabenlimab. The first participants received a low dose and participants who started the study later received higher doses, if the
lower doses were well tolerated. Participants received 1 dose of BI 1387446, every week at the beginning and then every 3 weeks, in combination with ezabenlimab, every 3 weeks.
Participants received between 50 μg and 200 μg of BI 1387446 (injected into the tumour) in combination with 240 mg of ezabenlimab (as an infusion into a vein). The participants and doctors knew which dose each participant was receiving.
The researchers wanted to find the highest dose of BI 1387446 participants could tolerate when taken together with ezabenlimab. To find out, the researchers looked at the number of participants with certain severe health problems (unwanted effects) that the doctors think are caused by the study medicine, which limited any further increase in the dose.
Participants could stay in the study for up to 2 years and 8 months, as long as they tolerated the treatment.
Participants visited the doctors regularly. During these visits, the doctors collected information about the participants’ health and noted any health problems.
What were the results of this study?
The highest dose of BI 1387446 the participants could tolerate was not determined.
Did participants have any unwanted effects in this study?
Yes, participants in both Part A and Part B of the study, had unwanted effects. Unwanted effects are health problems that the doctors think were caused by the study medicines. In this study, in Part A, 14 out of 26 participants (54%) had unwanted effects when they received BI 1387446. In Part B, 10 out of 16 participants (62%) had unwanted effects when they received BI 1387446. In Part B, 8 out of 16 participants (50%) had unwanted effects when they received ezabenlimab.
The listing below shows the 5 most common unwanted effects in the BI 1387446 and ezabenlimab groups, both in Part A and Part B of the study. The listing also shows how many participants in each group had each of these unwanted effects. Part A (BI 1387446 alone) had 26 participants, Part B (BI 1387446) had 16 participants and Part B (ezabenlimab) had 16 participants.
Pain at the injection site (injection site pain): 4 participants of Part A (15%), 0 participants of Part B (0%)
Fever (pyrexia): 3 participants of Part A (12%), 2 participants of Part B (12%)
Fatigue: 3 participants of Part A (12%), 1 participant of Part B (6%)
Itchy skin (pruritus): 2 participants of Part A (8%), 0 participants of Part B (0%)
Weakness (asthenia): 1 participant of Part A (4%), 4 participants of Part B (25%)
None of the unwanted effects were serious. This means that the unwanted effects did not lead to a hospital stay, were not life-threatening and did not lead to a disability.
Where did the study take place?
The following listing shows the regions and countries with the number of participants.
Europe (37): Spain (30; 4 participants from Spain participated in both parts), United Kingdom (11)
North America (1): United States of America (1)
The total number of participants in the European Union was 26.
Is there more information about this study?
More scientific details are available. You can find further information about this study at these websites:
1. Go to www.mystudywindow.com/completed and search for the study number 1426-0001.
2. Go to www.clinicaltrialsregister.eu/ctr-search and search for the EudraCT number 2019-001082-32.
3. Go to www.clinicaltrials.gov and search for the NCT number NCT04147234.
Boehringer Ingelheim sponsored this study. For contact details, please visit www.boehringer-ingelheim.com/contact-us.
The full title of the study is Phase I, first in human trial evaluating BI 1387446 alone and in combination with ezabenlimab (BI 754091) in solid tumours
This study started in August 2020 and finished in March 2024.
Are there additional studies?
We decided to stop the development of BI 1387446. Therefore, no additional studies are planned.
Important notice
This lay summary is provided as part of Boehringer Ingelheim’s commitment to publicly share clinical study results.
This summary shows only the results from one study and may not represent all of the knowledge about the medicine studied. Other studies may have different results. Usually, more than one study is carried out to find out how well a medicine works and to determine the side effects of a medicine.
This lay summary may include uses, formulations, or treatment regimens for the medicine studied that may be approved or not approved in your country. This lay summary is not intended to promote any product or indication, to guide treatment decisions, or to replace the advice of a healthcare professional.
You should not change your therapy based on the results of this study. Always consult with your treating physician about your therapy.
©2025 Boehringer Ingelheim International GmbHREC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0514
Date of REC Opinion
4 Dec 2019
REC opinion
Further Information Favourable Opinion