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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05963867
Other study ID # 1438-0004
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 22, 2024
Est. completion date July 25, 2026

Study information

Verified date March 2024
Source Boehringer Ingelheim
Contact Boehringer Ingelheim
Phone 1-800-243-0127
Email clintriage.rdg@boehringer-ingelheim.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date July 25, 2026
Est. primary completion date January 18, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
BI 764532
BI 764532
[89Zr]Zr-BI 764532
[89Zr]Zr-BI 764532

Locations

Country Name City State
Netherlands Amsterdam UMC Locatie VUMC Amsterdam

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean relative change from baseline of [89Zr]Zr-BI 764532 tumour-to-plasma ratios in all detectable lesions post BI 764532 doses at baseline and up to 35 days
See also
  Status Clinical Trial Phase
Recruiting NCT05882058 - DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers Phase 2
Recruiting NCT04086485 - Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET) Phase 1/Phase 2
Recruiting NCT03206060 - Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma Phase 2
Recruiting NCT05879978 - 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 Phase 1/Phase 2
Recruiting NCT06240741 - A Prospective, Open-label Study of [68Ga]Ga-DOTA-TATE in Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan Phase 3
Recruiting NCT06132113 - DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers Phase 1
Terminated NCT02315625 - Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery Phase 2

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