Actively Recruiting
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
Led by Boehringer Ingelheim · Updated on 2026-05-08
12
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how the medicine BI 764532 is distributed in the body and in tumors in adults with small cell lung cancer or other neuroendocrine cancers. This study focuses on people with advanced cancer who have not responded to previous treatments or for whom no standard treatments exist. The goal is to understand the behavior of BI 764532 within tumors to support future care options. Participants receive BI 764532 as their starting treatment. During the initial weeks, doctors use imaging methods to observe how the medicine is taken up by tumors. If the treatment shows potential benefits and is well tolerated, it continues for up to the maximum study duration. Participants attend regular study visits, with the frequency depending on their response and ability to tolerate the treatment. Throughout the study, researchers monitor participants’ health and any unwanted effects. They collect data on tumor response using imaging and regularly check the participants' overall condition. The main measurement is the change in tumor-to-plasma ratios of BI 764532 within 35 days after dosing. The total number of visits and study length vary based on individual tolerance and response to treatment, with ongoing health assessments by the study team.
CONDITIONS
Brief Title
A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Weight at least 60 kg
- Signed and dated informed consent form prior to any trial procedures
- Patient with small cell lung cancer or neuroendocrine cancer who failed conventional treatments or has no effective standard options
- Previous therapy should include at least one line of platinum-based chemotherapy
- Previous anti-PD-1 or PD-L1 therapy allowed
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one evaluable lesion outside of the central nervous system
- For patients with brain metastases: radiotherapy or surgery completed at least 2 weeks before starting study drug
- Off steroids for at least 7 days (physiologic doses allowed)
- Off anti-epileptic drugs for at least 7 days or on stable doses for malignant CNS disease
You will not qualify if you...
- Previous or concurrent malignancies within last 2 years except effectively treated non-melanoma skin cancer, carcinoma in situ of cervix, ductal carcinoma in situ, or other cured malignancies
- Major injuries, surgery, or bone fracture within 28 days before first dose or planned surgery
- Known leptomeningeal disease or spinal cord compression from metastases
- Anticoagulant treatment that cannot be safely interrupted if needed
- Active infection requiring medical therapy
- SARS-CoV-2 infection within 2 weeks before study entry or suspected infection or recent close contact
- Laboratory evidence of hepatitis B or C infection
- Known HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 35 days
Participants receive doses of BI 764532 and [89Zr]Zr-BI 764532 to investigate drug distribution and tumour uptake.
Several visits during dosing and imaging assessments
Trial Site Locations
Total: 1 location
1
Amsterdam UMC Locatie VUMC
Amsterdam, Netherlands, 1081HV
Actively Recruiting
Research Team
B
Boehringer Ingelheim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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