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A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for Delta-Like Ligand 3 (DLL3).

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ClinicalTrials.gov Identifier: NCT04429087
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : March 21, 2023
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

To determine the maximum tolerated dose(s) (MTD) or the Recommended Dose for Expansion (RDE) and dosing regimen for further development of BI 764532. The MTDs will be defined based on the frequency of patients experiencing dose limiting toxicities (DLTs) during the MTD evaluation period in studied regimens. The RDE will be guided by overall safety, efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) assessments.

Additional objectives are to document the safety and tolerability of BI 764532, to characterise pharmacokinetics and pharmacodynamics, and to evaluate efficacy signals.

Phase Ib will further explore BI 764532 in selected patients populations based on data from phase Ia.

The Phase Ib objectives, endpoints and design will be specified in a study protocol amendment after availability of phase Ia results.

Condition or disease Intervention/treatment Phase
Patients With Small Cell Lung Carcinoma and Other Neoplasms Drug: BI 764532 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First -in Human Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of BI 764532 Administered by Repeated Intravenous Infusions in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: BI 764532 Drug: BI 764532
BI 764532

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) [ Time Frame: up to 36 months ]
    Maximum tolerated dose (MTD) in any studied regimen defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal or above 33% during the MTD evaluation period. Separate MTDs will be determined for each Regimen.

  2. Number of patients with DLTs in the MTD evaluation period [ Time Frame: up to 36 months ]

Secondary Outcome Measures :
  1. Cmax: maximum measured concentration of BI 764532 [ Time Frame: up to 36 months ]
  2. AUCτ: area under the concentration-time curve of the analyte over a uniform dosing interval τ [ Time Frame: up to 36 months ]
  3. Objective response based on RECIST 1.1 criteria in patients with measurable disease [ Time Frame: up to 36 months ]
    Objective response based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients with measurable disease

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed and dated, written informed consent form (ICF2) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
  • Locally advanced or metastatic cancer not amenable to curative treatment; of 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 DLL3 expression (on archived tissue or instudy fresh biopsy) according to central pathology review in order to start BI 764532
    • Patients with tumours 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 tumour tissue.
  • For back-fill cohorts only: patient has agreed to and signed an IC to provide mandatory pre-treatment and on-treatment fresh tumor biopsy.
  • Patient has failed or is not eligible for available standard therapies according to local guidelines. Standard therapies should include at least one line of chemotherapy that should include platinum for patients with small cells carcinoma tumors histologies.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • At least one evaluable lesion outside of CNS as defined per modified Response Evaluation Criteria In Solid Tumors (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 Central Nervous System (CNS) disease.
  • Adequate liver, bone marrow and renal organ function Futher inclusion criteria apply

Exclusion Criteria:

  • Previous treatment with T cell Engager (TcE) or cell therapies targeting Delta-Like Ligand 3 (DLL3).
  • Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy).
  • Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, CTCAE Grade 2 neuropathy, asthenia/fatigue or grade 2 endocrinopathies controlled by replacement therapy).
  • Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532. Physiological replacement of steroids is allowed.
  • Prior anti-cancer therapy:

    • Patients who have been treated with any other anti-cancer drug within 3 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532.
    • Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532.
  • Other active malignancy that could interfere with the prognosis and treatment of the disease of the study.
  • Major surgery within 28 days of first dose BI 764532.
  • Women who are pregnant, nursing/breast feeding or who plan to become pregnant or nurse while in the trial or within 3 months after the last dose of study treatment.
  • Active infection that requires medical therapy or other clinically significant intervention or within 2 weeks prior to study entry confirmed (PCR test or other applicable test as per local requirments) or suspected SARS-CoV-2 infection or close contact with an individual with confirmed SARS-CoV-2 infection.

Further exclusion criteria apply

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): NCT04429087

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

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United States, Georgia
Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
Universitätsklinikum Carl Gustav Carus Dresden Recruiting
Dresden, Germany, 01307
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
Universitätsklinikum Köln (AöR) Recruiting
Köln, Germany, 50937
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
Universitätsklinikum Würzburg AÖR Recruiting
Würzburg, Germany, 97080
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
National Cancer Center Hospital East Recruiting
Chiba, Kashiwa, Japan, 277-8577
Contact: Boehringer Ingelheim    0120201230    nippon@bitrialsupport.com   
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Boehringer Ingelheim    900876092    espana@bitrialsupport.com   
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Boehringer Ingelheim    900876092    espana@bitrialsupport.com   
Clínica Universidad de Navarra Recruiting
Pamplona, Spain, 31008
Contact: Boehringer Ingelheim    900876092    espana@bitrialsupport.com   
Hospital Clínico de Valencia Recruiting
Valencia, Spain, 46010
Contact: Boehringer Ingelheim    900876092    espana@bitrialsupport.com   
Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04429087    
Other Study ID Numbers: 1438-0001
2019-000729-31 ( EudraCT Number )
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: March 21, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).For more details refer to: 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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Lung Neoplasms
Small Cell Lung Carcinoma
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