Trial Title:
A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6
NCT ID:
NCT06091930
Condition:
Gastrointestinal Cancer
Lung Cancer
Pancreatic Cancer
Colorectal Cancer
Head and Neck Cancer
Liver Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
The trial is divided in four parts. Part I and Part III will have a sequential assignment
while Part II and Part IV will have a parallel assignment.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
All trial parts will be conducted open label.
Intervention:
Intervention type:
Drug
Intervention name:
BI 765049
Description:
BI 765049
Arm group label:
Part I: BI 765049
Arm group label:
Part II: BI 765049
Arm group label:
Part III: BI 765049 + ezabenlimab
Arm group label:
Part IV: BI 765049 + ezabenlimab
Intervention type:
Drug
Intervention name:
Ezabenlimab
Description:
Ezabenlimab
Arm group label:
Part III: BI 765049 + ezabenlimab
Arm group label:
Part IV: BI 765049 + ezabenlimab
Other name:
BI 754091
Summary:
This is a study in adults from Asia with different types of advanced cancer (solid
tumours). People can join the study if they have cancer of the stomach, large bowel and
rectum, pancreas, liver, head and neck or non-small cell lung cancer. This is a study for
people for whom previous treatment was not successful or no treatment exists. People can
participate if their tumour has the B7-H6 marker.
The purpose of this study is to find the highest dose of BI 765049 that people with
advanced cancer can tolerate when taken (alone and) together with ezabenlimab. Another
purpose is to check whether BI 765049 taken (alone and) together with ezabenlimab can
make tumours shrink. Both medicines may help the immune system fight cancer.
Participants can stay in the study up to 3 years, as long as they can tolerate it and can
benefit from it. During this time, they visit the study site about every 3 weeks. At the
study site they get BI 765049 alone or in combination with ezabenlimab as an infusion
into a vein. BI 765049 is given in 3-week cycles, ezabenlimab is given once every 3
weeks.
The doctors check the health of the participants and note any health problems that could
have been caused by BI 765049 or ezabenlimab. Doctors regularly check the size of the
tumour and check whether it has spread to other parts of the body.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Signed and dated, written inform consent form (ICF) (ICF1 for B7-H6 testing for all
patients except those with colorectal cancer (CRC); ICF2 for all patients)
describing the study in accordance with International Council on Harmonisation Good
Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific
procedures, sampling, or analyses.
- ≥18 years of age at the time of signature on the ICFs (ICF1 and ICF2).
- Histologically or cytologically confirmed diagnosis of an advanced, unresectable,
and/or metastatic gastrointestinal cancer, colorectal cancer, pancreatic cancer,
liver cancer, head and neck cancer, or lung cancer.
- Disease progression despite conventional treatment, intolerant to or not a candidate
for conventional treatment, or with a tumour for which no conventional treatment
exists.
- Agree to the collection of tumour samples (as slides from archival diagnostic
samples or fresh tumour biopsies) for confirmation of B7-H6 expression at Screening
Visit 02 for colorectal cancer (CRC) patients or at Screening Visit 01 for all other
patients.
- Confirmed B7-H6 expression on tumour tissue sample (archived or fresh tumour biopsy)
based on central pathology review except for patients diagnosed with advanced or
metastatic colorectal cancer (CRC).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- At least one evaluable target lesion as defined per response evaluation criteria in
solid tumors (RECIST v1.1), outside of the central nervous system (CNS), separate
from any lesion(s) identified for tumour biopsy. Tumour lesions that have been
irradiated ≥28 days before the start of treatment, and have subsequently had
documented progression, may be chosen as target lesions only in the absence of
measurable lesions that have not been irradiated.
- Further inclusion criteria apply
Exclusion Criteria:
- History of a major surgery within 28 days prior to first dose of BI 765049 (major
according to the Investigator's assessment).
- Presence of other active invasive cancers other than the one treated in this trial
within 3 years prior to screening, except for appropriately treated basal cell
carcinoma of the skin, in situ carcinoma of the uterine cervix, or other local
tumours considered cured by local treatment.
- Known leptomeningeal disease or spinal cord compression due to disease.
- Require anticoagulant treatment which cannot be safely interrupted, if medically
needed for a study procedure (e.g., biopsy) based on the opinion of the
Investigator.
- Any of the following laboratory evidence of hepatitis virus infection. Test results
obtained in routine diagnostics are acceptable for screening if done within 14 days
before the ICF2 date: positive results of hepatitis B surface (HBs) antigen,
presence of hepatitis B core (HBc) antibody together with hepatitis B virus
(HBV)-DNA and presence of hepatitis C-RNA
- Infection requiring systemic antimicrobial, antiviral, antiparasitic, or antifungal
therapy at the start of treatment in the trial unless otherwise stipulated.
- Patients with history of human immunodeficiency virus (HIV) infection who meet one
or more of the following criteria: cluster of differentiation 4 (CD4)+ count <350
cells/μL, viral load >400 copies/μL, not receiving antiretroviral therapy, receiving
established antiretroviral therapy for less than four weeks prior to the start of
study treatment, and history of AIDS-defining opportunistic infections within 12
months prior to start of study treatment. Patients with a history of HIV who do not
meet any of the criteria above are eligible to participate, but the patient must be
under the care of a HIV/Infectious Diseases specialist, or a HIV/Infectious Diseases
specialist must be consulted prior to inclusion.
- Previous treatment history: previous treatment in this trial or another trial with a
B7-H6 targeting agent, treatment with a systemic anti-cancer therapy or
investigational drug within 21 days or 5 half-lives (whichever is shorter) of the
first administration of BI 765049, and treatment with extensive field radiotherapy
including whole brain irradiation within14 days prior to first administration of BI
765049.
- Further exclusion criteria apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Chiba, Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo, Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Japanese Foundation for Cancer Research
Address:
City:
Tokyo, Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Start date:
January 31, 2024
Completion date:
February 11, 2027
Lead sponsor:
Agency:
Boehringer Ingelheim
Agency class:
Industry
Source:
Boehringer Ingelheim
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06091930
https://www.mystudywindow.com
