RecruitingPhase 1NCT05963867

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

Sponsor

Boehringer Ingelheim

Enrollment

12 participants

Start Date

Aug 6, 2024

Study Type

INTERVENTIONAL

Conditions

Small Cell Lung Carcinoma (SCLC)Neuroendocrine Neoplasms

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called BI 764532 in people with small-cell lung cancer or neuroendocrine cancer — aggressive cancers that can be difficult to treat. The study uses PET imaging to see how much of the drug accumulates in tumors, which helps researchers understand whether it reaches cancer cells effectively. **You may be eligible if...** - You are 18 or older and weigh at least 60 kg - You have confirmed small-cell lung cancer or neuroendocrine cancer - Your tumor expresses a protein targeted by BI 764532 (DLL3 positive) - Your overall health is adequate for the study procedures **You may NOT be eligible if...** - You have serious heart, liver, or kidney problems - You have had recent major surgery or radiation - You are on medications that significantly interfere with the study drug - You are pregnant or breastfeeding - You are not able to undergo PET imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBI 764532

BI 764532

DRUG[89Zr]Zr-BI 764532

\[89Zr\]Zr-BI 764532

Locations(1)

Amsterdam UMC Locatie VUMC

Amsterdam, Netherlands

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NCT05963867

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