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

Phase 1

Recruiting

• Conditions: Carcinoma, Squamous Cell of Head and Neck (HNSCC); Melanoma; Non-small Cell Lung Cancer (NSCLC)
• Interventions: Drug: Ezabenlimab; Drug: BI 765063; Drug: BI 770371; Drug: [89Zr]Zr- BI 765063; Drug: [89Zr]Zr- BI 770371

• Registration Number: NCT05068102
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-19
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-10-05
• Study Start: 2022-03-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-10-16
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm B	BI 770371	-
Arm A	[89Zr]Zr- BI 765063	-
Arm B	Ezabenlimab	-
Arm B	[89Zr]Zr- BI 770371	-
Arm A	BI 765063	-
Arm A	Ezabenlimab	-

Primary Outcome Measures

Name	Time	Method
Arm A: Relative change from baseline (Cycle 1, up to Day 7) of peak Standardized Uptake Values (SUVs) of [89Zr]Zr-BI 765063 in up to five target lesions at post BI 765063 treatment scanning time points (Cycle 2, up to Day 7)	up to 33 months	peak SUVs are measured via Positron Emission Tomography (PET) scan
Arm B: Relative change from baseline (Cycle 1, up to Day 7) of peak Standardized Uptake Values (SUVs) of [89Zr]Zr-BI 770371 in up to five target lesions at post BI 770371 treatment scanning time points (Cycle 2, up to Day 7)	up to 33 months	peak SUVs are measured via Positron Emission Tomography (PET) scan

Trial Locations

Locations (1)

VU University Medical Center; 🇳🇱 Amsterdam, Netherlands