A Phase 1 interventional study of BI 765063 and Ezabenlimab in Carcinoma, Squamous Cell of Head and Neck (HNSCC), Melanoma and Non-small Cell Lung Cancer (NSCLC), sponsored by Boehringer Ingelheim. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 14 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Drug: BI 765063 · Drug: Ezabenlimab · Drug: [89Zr]Zr- BI 765063
Drug: Ezabenlimab · Drug: BI 770371 · Drug: [89Zr]Zr- BI 770371
BI 765063
Ezabenlimab
\[89Zr\]Zr- BI 765063, specifically radiolabelled for immune-Positron Emission Tomography (PET)
BI 770371
\[89Zr\]Zr- BI 770371, specifically radiolabelled for immune-PET
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)
peak SUVs are measured via Positron Emission Tomography (PET) scan
Time frame: up to 33 months
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)
peak SUVs are measured via Positron Emission Tomography (PET) scan
Time frame: up to 33 months
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim