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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

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ClinicalTrials.gov Identifier: NCT05879978
Recruitment Status : Recruiting
First Posted : May 30, 2023
Last Update Posted : April 17, 2024
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Small Cell Lung Carcinoma (SCLC) Neuroendocrine Neoplasms Drug: BI 764532 Drug: Ezabenlimab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of BI 764532 Combined With Ezabenlimab in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3
Actual Study Start Date : May 31, 2023
Estimated Primary Completion Date : February 28, 2025
Estimated Study Completion Date : February 28, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: BI 764532 + ezabenlimab treatment group
Successive cohorts of patients will receive increasing doses of BI 764532 in combination with ezabenlimab until the maximum tolerated dose (MTD) is reached, or upon decision of Dose Escalation Committee (DEC).
 Drug: BI 764532
BI 764532

Drug: Ezabenlimab
Ezabenlimab


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period [ Time Frame: up to 19 months ]

Secondary Outcome Measures :
  1. Occurrence of DLTs during the on-treatment period [ Time Frame: up to 19 months ]
  2. Objective response, defined as best overall response of complete response (CR) or partial response (PR) [ Time Frame: up to 19 months ]
    Objective response, defined as best overall response of complete response (CR) or partial response (PR), where best overall response is determined by the investigator's assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 in patients with measurable disease from date of first treatment administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent

  3. Cmax (maximum measured concentration of BI 764532) [ Time Frame: up to 19 months ]
  4. Cmax (maximum measured concentration of ezabenlimab) [ Time Frame: up to 19 months ]
  5. AUCτ (area under the concentration-time curve of BI 764532 over a uniform dosing interval τ) [ Time Frame: up to 19 months ]
  6. AUCτ (area under the concentration-time curve of ezabenlimab) over a uniform dosing interval τ) [ Time Frame: up to 19 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05879978


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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Belgium
Brussels - UNIV Saint-Luc Recruiting
Bruxelles, Belgium, 1200
Contact: Boehringer Ingelheim    080049616    belgique@bitrialsupport.com   
UNIV UZ Gent Recruiting
Gent, Belgium, 9000
Contact: Boehringer Ingelheim    080049616    belgique@bitrialsupport.com   
France
HOP Louis Pradel Recruiting
Bron, France, 69677
Contact: Boehringer Ingelheim    0805102354    france@bitrialsupport.com   
CTR François Baclesse Recruiting
Caen, France, 14000
Contact: Boehringer Ingelheim    0805102354    france@bitrialsupport.com   
INS Claudius Regaud IUCT-Oncopole Recruiting
Toulouse, France, 31059
Contact: Boehringer Ingelheim    0805102354    france@bitrialsupport.com   
Germany
Universitätsklinikum Carl Gustav Carus Dresden Recruiting
Dresden, Germany, 01307
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
Universitätsklinikum Frankfurt Recruiting
Frankfurt, Germany, 60590
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
Japan
National Cancer Center Hospital Recruiting
Tokyo, Chuo-ku, Japan, 104-0045
Contact: Boehringer Ingelheim    0120201230    nippon@bitrialsupport.com   
Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT05879978    
Other Study ID Numbers: 1438-0002
2022-502728-30-00 ( Registry Identifier: CTIS )
First Posted: May 30, 2023    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
URL: https://www.mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Lung Neoplasms
Small Cell Lung Carcinoma
Neuroendocrine Tumors
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue