NCT05068102

A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab

An Open Label Phase I PET Imaging Study to Investigate the Bio-distribution and Tumor Uptake of [89Zr]Zr-BI 765063 and [89Zr]Zr-BI 770371 in Patients With Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer or Melanoma Who Are Treated With Ezabenlimab

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with advanced head and neck cancer, skin cancer, or non-small cell lung cancer. People can take part if previous treatments were not successful. The purpose of this study is to find out how 2 medicines called BI 765063 and BI 770371 are taken up in the tumours and how they get distributed in the body. In addition to BI 765063 or BI 770371, participants also receive ezabenlimab. BI 765063, BI 770371 and ezabenlimab are antibodies that may help the immune system fight cancer. Such therapies are also called immune checkpoint inhibitors. Participants get either BI 765063 or BI 770371 in combination with ezabenlimab as an infusion into a vein every 3 weeks. In the first weeks, doctors check how BI 765063 and BI 770371 are taken up in tumours. To do so, the doctors use imaging methods (PET/CT scans). For this, participants get BI 765063 or BI 770371 injected in a labelled form up to 2 times. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors regularly check participants' health and take note of any unwanted effects.

Conditions

• Carcinoma, Squamous Cell of Head and Neck (HNSCC)
• Melanoma
• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	BI 765063	BI 765063
DRUG	Ezabenlimab	Ezabenlimab
DRUG	[89Zr]Zr- BI 765063	\[89Zr\]Zr- BI 765063, specifically radiolabelled for immune-Positron Emission Tomography (PET)
DRUG	BI 770371	BI 770371
DRUG	[89Zr]Zr- BI 770371	\[89Zr\]Zr- BI 770371, specifically radiolabelled for immune-PET

Timeline

• Start date: 2022-03-03
• Primary completion: 2026-04-03
• Completion: 2026-05-31
• First posted: 2021-10-05
• Last updated: 2026-02-18

Locations

1 site across 1 country: Netherlands