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DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With Topotecan

Primary Purpose

Small Cell Lung Carcinoma (SCLC)

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BI 764532
Topotecan
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: 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 informed consent form (ICF). Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Histologically or cytologically confirmed small cell lung cancer (SCLC) Extensive stage - small cell lung cancer (ES-SCLC) that progressed or recurred following platinum-based treatment, and anti- programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) as applicable Patients must be eligible for topotecan treatment according to label Availability of archival tumour tissue sample Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Further inclusion criteria apply Exclusion Criteria: Previous treatment in this trial Current enrolment in another investigational device or drug trial, or <30 days since ending another investigational device or drug trial(s) Untreated or symptomatic brain metastases. Participants with treated, stable brain metastases are eligible provided they meet the following criteria: Radiotherapy or major surgery for brain metastases was completed at least 2 weeks (for radiotherapy) or 4 weeks (for major brain metastases surgery) 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 central nervous system (CNS) disease. Presence of leptomeningeal carcinomatosis Previous treatment with T cell engager (TcE) or cell therapies targeting delta-like ligand 3 (DLL3). Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, CTCAE Grade 2 neuropathy, or Grade 2 endocrinopathies controlled by replacement therapy). Major surgery (major according to the investigator's assessment) within 28 days prior to first administration of BI 764532 or planned during treatment period, e.g. hip replacement. 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 Further exclusion criteria apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Part A: BI 764532 low dose + topotecan

    Part A: BI 764532 medium dose + topotecan

    Part A: BI 764532 high dose + topotecan

    Part B: BI 764532 + topotecan

    Arm Description

    Outcomes

    Primary Outcome Measures

    Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
    Part B: Occurrence of DLTs during the on-treatment period
    Part B: Occurrence of AEs during the on-treatment period

    Secondary Outcome Measures

    Part A: Occurrence of DLTs during the on-treatment period
    Part A: Occurrence of AEs during the on-treatment period
    Part B: Objective response
    Part B: Duration of response

    Full Information

    First Posted
    August 7, 2023
    Last Updated
    September 7, 2023
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05990738
    Brief Title
    DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With Topotecan
    Official Title
    DAREON™-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With Topotecan for the Treatment of Patients With Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 15, 2023 (Anticipated)
    Primary Completion Date
    October 27, 2025 (Anticipated)
    Study Completion Date
    December 31, 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 is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive topotecan treatment. The purpose of this study is to find out the highest dose of BI 764532 that people can tolerate when taken together with topotecan. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants get BI 764532 and topotecan as infusions into a vein. As an alternative, topotecan may also be taken orally (tablets). Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. During this time, participants visit the study site regularly. 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.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Part A: BI 764532 low dose + topotecan
    Arm Type
    Experimental
    Arm Title
    Part A: BI 764532 medium dose + topotecan
    Arm Type
    Experimental
    Arm Title
    Part A: BI 764532 high dose + topotecan
    Arm Type
    Experimental
    Arm Title
    Part B: BI 764532 + topotecan
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    BI 764532
    Intervention Description
    BI 764532
    Intervention Type
    Drug
    Intervention Name(s)
    Topotecan
    Intervention Description
    Topotecan
    Primary Outcome Measure Information:
    Title
    Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
    Time Frame
    up to 9 weeks
    Title
    Part B: Occurrence of DLTs during the on-treatment period
    Time Frame
    up to 36 months
    Title
    Part B: Occurrence of AEs during the on-treatment period
    Time Frame
    up to 36 months
    Secondary Outcome Measure Information:
    Title
    Part A: Occurrence of DLTs during the on-treatment period
    Time Frame
    up to 36 months
    Title
    Part A: Occurrence of AEs during the on-treatment period
    Time Frame
    up to 36 months
    Title
    Part B: Objective response
    Time Frame
    up to 36 months
    Title
    Part B: Duration of response
    Time Frame
    up to 36 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 informed consent form (ICF). Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Histologically or cytologically confirmed small cell lung cancer (SCLC) Extensive stage - small cell lung cancer (ES-SCLC) that progressed or recurred following platinum-based treatment, and anti- programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) as applicable Patients must be eligible for topotecan treatment according to label Availability of archival tumour tissue sample Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Further inclusion criteria apply Exclusion Criteria: Previous treatment in this trial Current enrolment in another investigational device or drug trial, or <30 days since ending another investigational device or drug trial(s) Untreated or symptomatic brain metastases. Participants with treated, stable brain metastases are eligible provided they meet the following criteria: Radiotherapy or major surgery for brain metastases was completed at least 2 weeks (for radiotherapy) or 4 weeks (for major brain metastases surgery) 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 central nervous system (CNS) disease. Presence of leptomeningeal carcinomatosis Previous treatment with T cell engager (TcE) or cell therapies targeting delta-like ligand 3 (DLL3). Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, CTCAE Grade 2 neuropathy, or Grade 2 endocrinopathies controlled by replacement therapy). Major surgery (major according to the investigator's assessment) within 28 days prior to first administration of BI 764532 or planned during treatment period, e.g. hip replacement. 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 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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