New imaging trial peers inside tumors to track experimental Drug's path
NCT ID NCT05963867
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This study uses a special PET scan to see how the experimental drug BI 764532 travels through the body and reaches tumors. It is for adults with advanced small cell lung cancer or other neuroendocrine cancers who have run out of standard treatment options. The main goal is to measure how much of the drug gets into tumors, not to test if it cures the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Amsterdam UMC Locatie VUMC
RECRUITINGAmsterdam, 1081HV, Netherlands
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Other studies related to the condition(s) this trial covers.
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