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NCT05963867RecruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
12 (estimated)
First submitted
18 Jul 2023
Start date
6 Aug 2024
Primary completion date
15 Dec 2026
Lead sponsor
Boehringer Ingelheim
NCT number
NCT05963867

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 12
  • From 6 Aug 2024 to the primary completion date, 15 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • Known leptomeningeal disease or spinal cord compression due to metastatic disease
  • Active infection that requires medical therapy or other clinically significant intervention
  • Known human immunodeficiency virus (HIV) infection. Further exclusion criteria apply.

Lab values

  • 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)

Other

  • Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Amsterdam UMC Locatie VUMC
Coordinator of this site? Confirm its status
AmsterdamNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.