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A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer

Primary Purpose

Small Cell Lung Carcinoma (SCLC), Neuroendocrine Neoplasms

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BI 764532
[89Zr]Zr-BI 764532
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Carcinoma (SCLC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years Weight ≥ 60kg Signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses. 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. Previous therapy with anti Programmed Cell Death Protein 1 (PD-1) or Programmed Cell Death Ligand 1 (PD-L1) are allowed. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. At least one evaluable lesion outside of Central Nervous System (CNS) as defined per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 Subjects with brain metastases are eligible provided they meet the following criteria: radiotherapy or surgery for brain metastases was completed at least 2 weeks 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. Further inclusion criteria apply. Exclusion Criteria: 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 Major injuries and/or surgery or bone fracture within 28 days of first dose BI 764532, or planned surgical procedures Known leptomeningeal disease or spinal cord compression due to metastatic disease Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed Active infection that requires medical therapy or other clinically significant intervention Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 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 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 DNA (HBV-DNA) Presence of hepatitis C ribonucleic acid (RNA) Known human immunodeficiency virus (HIV) infection. Further exclusion criteria apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Cohort 1

    Cohort 2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mean relative change from baseline of [89Zr]Zr-BI 764532 tumour-to-plasma ratios in all detectable lesions post BI 764532 doses

    Secondary Outcome Measures

    Full Information

    First Posted
    July 18, 2023
    Last Updated
    September 18, 2023
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05963867
    Brief Title
    A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer
    Official Title
    An Open-label Phase 1 PET Imaging Trial to Investigate [89Zr]Zr-BI 764532 Biodistribution and Tumour Uptake in Patients With Small-cell Lung Carcinoma or Neuroendocrine Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 16, 2023 (Anticipated)
    Primary Completion Date
    January 18, 2026 (Anticipated)
    Study Completion Date
    July 25, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is open to adults with small cell lung cancer and other neuroendocrine cancers. 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 how a medicine called BI 764532 gets distributed in the body and in tumours. Participants get BI 764532 when starting treatment. In the first weeks, doctors check how BI 764532 is taken up in tumours by means of an imaging method. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Small Cell Lung Carcinoma (SCLC), Neuroendocrine Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort 1
    Arm Type
    Experimental
    Arm Title
    Cohort 2
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    BI 764532
    Intervention Description
    BI 764532
    Intervention Type
    Drug
    Intervention Name(s)
    [89Zr]Zr-BI 764532
    Intervention Description
    [89Zr]Zr-BI 764532
    Primary Outcome Measure Information:
    Title
    Mean relative change from baseline of [89Zr]Zr-BI 764532 tumour-to-plasma ratios in all detectable lesions post BI 764532 doses
    Time Frame
    at baseline and up to 35 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥18 years Weight ≥ 60kg Signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses. 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. Previous therapy with anti Programmed Cell Death Protein 1 (PD-1) or Programmed Cell Death Ligand 1 (PD-L1) are allowed. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. At least one evaluable lesion outside of Central Nervous System (CNS) as defined per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 Subjects with brain metastases are eligible provided they meet the following criteria: radiotherapy or surgery for brain metastases was completed at least 2 weeks 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. Further inclusion criteria apply. Exclusion Criteria: 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 Major injuries and/or surgery or bone fracture within 28 days of first dose BI 764532, or planned surgical procedures Known leptomeningeal disease or spinal cord compression due to metastatic disease Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed Active infection that requires medical therapy or other clinically significant intervention Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 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 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 DNA (HBV-DNA) Presence of hepatitis C ribonucleic acid (RNA) Known human immunodeficiency virus (HIV) infection. Further exclusion criteria apply.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Boehringer Ingelheim
    Phone
    1-800-243-0127
    Email
    clintriage.rdg@boehringer-ingelheim.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
    Links:
    URL
    https://www.mystudywindow.com
    Description
    Related Info

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    A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer

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