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A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With a Tumour in the Brain That is Positive for DLL3

Primary Purpose

Glioma

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

About this trial

This is an interventional treatment trial for Glioma

Eligibility Criteria

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

Inclusion Criteria: Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the first informed consent form (ICF1). Signed and dated written informed consent (ICF1 and ICF2) in accordance with International Council for Harmonisation-Good clinical practice (ICH-GCP) and local legislation prior to admission to the trial. Patients with histologically confirmed primary progressive diffuse glioma who have failed standard of care therapies. Availability of archival tumour tissue for Delta-like 3 (DLL3) expression by central assessment. Tumours must be positive for DLL3 expression by immunohistochemistry (IHC) on archived tumour tissue according to central pathology review. Documented unequivocal progression after radiotherapy and/or chemotherapy with measurable disease by response assessment in neuro-oncology (RANO) criteria. Karnofsky performance score ≥70. Further inclusion criteria apply. Exclusion Criteria: Previous treatment in this trial. Current enrolment in another investigational device or drug trial. Presence of extracranial metastatic or leptomeningeal disease. Previous treatment with therapies targeting DLL3. Prior treatment with bevacizumab or other anti-vascular endothelial growth factor (anti-VEGF) or anti-angiogenic treatment within 6 months prior to first administration of BI 764532. Recent anti-cancer therapy: treatment with any other anticancer drug within 21 days or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532. Radiotherapy within the 3 months prior to the diagnosis of progression; unless tumour progression is clearly outside the radiation field or tumour progression is unequivocally proven by surgery/biopsy. Further exclusion criteria apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    BI 764532: Part A - Dose escalation cohort

    BI 764532: Part B - Dose expansion cohort

    Arm Description

    Outcomes

    Primary Outcome Measures

    Part A: Occurrence of dose-limiting toxicity (DLT) during the maximum tolerated dose (MTD) evaluation period
    Part B: Occurrence of dose-limiting toxicity (DLT) during the entire treatment period

    Secondary Outcome Measures

    Part A: Occurrence of dose-limiting toxicity (DLT) during the entire treatment period

    Full Information

    First Posted
    June 15, 2023
    Last Updated
    October 17, 2023
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05916313
    Brief Title
    A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With a Tumour in the Brain That is Positive for DLL3
    Official Title
    A Phase Ib Open-label, Multi-center, Dose Escalation Trial of BI 764532 Given as Monotherapy Administered by Repeated Intravenous Infusions in Patients With Glioma Expressing DLL3
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2, 2023 (Anticipated)
    Primary Completion Date
    October 17, 2025 (Anticipated)
    Study Completion Date
    November 21, 2025 (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
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study (1438-0003) is open to adults with a tumour in the brain that is positive for the tumour marker delta-like 3 (DLL3). This study is in people with advanced cancer for whom previous treatment was not successful. The purpose of this study is to find out the highest dose of BI 764532 that people with a brain tumour that is positive for DLL3 can tolerate. BI 764532 is an antibody-like molecule that can attach and link together the cancer cells and T-cells of the immune system (DLL3/CD3 bispecific). This may help the immune system fight cancer. Participants get BI 764532 infusions into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is continued. During this time, participants visit the study site at regular intervals. The total number of visits depends on how they respond to and tolerate the treatment. The first study visits include staying to monitor participants' safety. 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
    Glioma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    35 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BI 764532: Part A - Dose escalation cohort
    Arm Type
    Experimental
    Arm Title
    BI 764532: Part B - Dose expansion cohort
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    BI 764532
    Intervention Description
    BI 764532
    Primary Outcome Measure Information:
    Title
    Part A: Occurrence of dose-limiting toxicity (DLT) during the maximum tolerated dose (MTD) evaluation period
    Time Frame
    up to 4 weeks
    Title
    Part B: Occurrence of dose-limiting toxicity (DLT) during the entire treatment period
    Time Frame
    up to 14 months
    Secondary Outcome Measure Information:
    Title
    Part A: Occurrence of dose-limiting toxicity (DLT) during the entire treatment period
    Time Frame
    up to 26 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the first informed consent form (ICF1). Signed and dated written informed consent (ICF1 and ICF2) in accordance with International Council for Harmonisation-Good clinical practice (ICH-GCP) and local legislation prior to admission to the trial. Patients with histologically confirmed primary progressive diffuse glioma who have failed standard of care therapies. Availability of archival tumour tissue for Delta-like 3 (DLL3) expression by central assessment. Tumours must be positive for DLL3 expression by immunohistochemistry (IHC) on archived tumour tissue according to central pathology review. Documented unequivocal progression after radiotherapy and/or chemotherapy with measurable disease by response assessment in neuro-oncology (RANO) criteria. Karnofsky performance score ≥70. Further inclusion criteria apply. Exclusion Criteria: Previous treatment in this trial. Current enrolment in another investigational device or drug trial. Presence of extracranial metastatic or leptomeningeal disease. Previous treatment with therapies targeting DLL3. Prior treatment with bevacizumab or other anti-vascular endothelial growth factor (anti-VEGF) or anti-angiogenic treatment within 6 months prior to first administration of BI 764532. Recent anti-cancer therapy: treatment with any other anticancer drug within 21 days or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532. Radiotherapy within the 3 months prior to the diagnosis of progression; unless tumour progression is clearly outside the radiation field or tumour progression is unequivocally proven by surgery/biopsy. 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
    http://www.mystudywindow.com
    Description
    Related Info

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    A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With a Tumour in the Brain That is Positive for DLL3

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