Trial Title:
A Study to Test How Well Different Doses of BI 764532 in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3
NCT ID:
NCT05879978
Condition:
Small Cell Lung Carcinoma (SCLC)
Neuroendocrine Neoplasms
Conditions: Official terms:
Carcinoma
Neoplasms
Lung Neoplasms
Neuroendocrine Tumors
Small Cell Lung Carcinoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BI 764532
Description:
BI 764532
Arm group label:
BI 764532 + ezabenlimab treatment group
Other name:
Obrixtamig
Intervention type:
Drug
Intervention name:
Ezabenlimab
Description:
Ezabenlimab
Arm group label:
BI 764532 + ezabenlimab treatment group
Summary:
This study is open to adults with small cell lung cancer and other neuroendocrine tumours
that are positive for the tumour marker Delta-like 3 (DLL3). The study is in people with
advanced cancer for whom previous treatment was not successful or no standard treatment
exists.
The purpose of this study is to find out the highest dose of BI 764532 that people can
tolerate when taken together with another medicine called ezabenlimab. BI 764532 and
ezabenlimab are antibodies that may help the immune system fight cancer. Participants get
BI 764532 and ezabenlimab as infusions into a vein.
If there is benefit for the participants and if they can tolerate it, the treatment is
given for a maximum of 3 years. During this time, participants visit the study site about
every week. The visits also depend on the response to the treatment. At the study visits,
the doctors check the health of the participants, take necessary laboratory tests, and
note any health problems that could have been caused by the study treatment.
Criteria for eligibility:
Criteria:
Inclusion criteria
1. Age ≥18 years
2. Signed and dated, written informed consent form (main ICF) in accordance with
ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or
analyses.
3. Diagnosed with locally advanced, metastatic or relapsed cancer not amenable to
curative treatment of the following histologies:
- Small cell lung carcinoma (SCLC)
- Large cells neuroendocrine lung carcinoma(LCNEC)
- Neuroendocrine carcinoma (NEC) or small cell carcinoma of any other origin
- Tumours must be positive for Delta-like 3 (DLL3) expression (on archived
tissue) according to central pathology review in order to start BI 764532
.
- Patients with tumors with mixed histologies for any above type are
eligible only if neuroendocrine carcinoma/small tumor cells component is
predominant and represent at least 50% of the overall tumor tissue.
4. Patient who 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 available treatment options known to prolong survival for their disease.
Previous therapies should include at least one line of platinum-based chemotherapy.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
6. At least one evaluable lesion outside of Central Nervous System (CNS) as defined per
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
7. Subjects with brain metastases are eligible provided they meet the following
criteria:
- radiotherapy or surgery for brain metastases was completed at least 2 weeks or
4 weeks respectively, prior to the first administration of BI 764532
- patient is off steroids for at least 7 days (physiologic doses of steroids are
permitted), and the patient is off anti-epileptic drugs for at least 7 days or
on stable doses of anti-epileptic drugs for malignant CNS disease.
8. Male or female patients. Women of childbearing potential (WOCBP)1 and men 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 3 months after the last dose of BI 764532. A list of contraception
methods meeting these criteria is provided in the patient information.
Further inclusion criteria apply.
Exclusion criteria
1. Previous treatment with T-cell-engager (TcE) or cell therapies targeting DLL3. Other
DLL3 targeting agents (like RovaT) are allowed only if DLL3 positivity is documented
after completion of treatment with DLL3 targeting agent in post-treatment biopsy.
2. Previous or concomitant malignancies other than the one treated in this trial within
the last 2 years except:
- effectively treated non-melanoma skin cancers
- effectively treated carcinoma in situ of the cervix
- effectively treated ductal carcinoma in situ
- other effectively treated malignancy that is considered cured by local
treatment
3. Major injuries and/or surgery or bone fracture within 28 days of first dose BI
764532, or planned surgical procedures
4. Known leptomeningeal disease or spinal cord compression due to metastatic disease
5. Anticoagulant treatment that cannot be safely interrupted based on opinion of the
investigator if medically needed
6. Patients who have been febrile, have had leukocytosis, or any clinical signs of
infection within 48 h prior to randomization/start of trial treatment are not
eligible. Oral or intravenous antimicrobials for management of fungal, bacterial,
viral, or other infection are prohibited within 7 days prior to randomization/start
of trial treatment. The use of antimicrobials for routine infection prophylaxis is
acceptable
7. Severe acute respiratory syndrome coronavirus 2 (SARS COV2) infection within 2 weeks
prior to study entry (confirmed via Polymerase chain reaction (PCR) test or other
applicable test as per local requirements) or suspected SARS-CoV-2 infection as per
physician assessment, or close contact (within 1 week) with an individual with
confirmed SARS-CoV-2 infection
8. Any of the following known laboratory evidence of hepatitis virus infection:
- Positive results of hepatitis B surface (HBs) antigen
- Presence of hepatitis B core (HBc) antibody together with hepatitis B virus
(HBV)-Deoxyribonucleic Acid (DNA)
- Presence of hepatitis C Ribonucleic acid (RNA) Further exclusion criteria
apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Brussels - UNIV Saint-Luc
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
080049616
Email:
belgique@bitrialsupport.com
Facility:
Name:
UNIV UZ Gent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
080049616
Email:
belgique@bitrialsupport.com
Facility:
Name:
HOP Louis Pradel
Address:
City:
Bron
Zip:
69677
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
CTR François Baclesse
Address:
City:
Caen
Zip:
14000
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
INS Claudius Regaud IUCT-Oncopole
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
Universitätsklinikum Carl Gustav Carus Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Universitätsklinikum Frankfurt
Address:
City:
Frankfurt
Zip:
60590
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@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
Start date:
May 31, 2023
Completion date:
June 6, 2025
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/NCT05879978
https://www.mystudywindow.com
