Carcinoma, Squamous Cell of Head and Neck (HNSCC)Phase 1NCT05068102

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

A Phase 1 study testing BI 765063, Ezabenlimab and [89Zr]Zr- BI 765063 in people with Carcinoma, Squamous Cell of Head and Neck (HNSCC) and Melanoma, run by Boehringer Ingelheim at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Squamous Cell of Head and Neck (HNSCC), Melanoma, Non-small Cell Lung Cancer (NSCLC)
What is being tested?: BI 765063, Ezabenlimab and [89Zr]Zr- BI 765063
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteNetherlands
Study dates: 3 Mar 2022to 25 Nov 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed and dated, written informed consent form (ICF) prior to any trial-specific procedures
Male or female aged ≥ 18 years (no upper limit of age) at the time of ICF signature
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of at least 3 months
For Arm A, only patients with a Signal Regulatory Protein-alpha (SIRPα) polymorphism V1/V1 will be eligible; SIRPα polymorphism will be assessed in blood sampling (patient deoxyribonucleic acid (DNA)) in a central laboratory; V1 allele is understood to include V1 and potential V1-like alleles. If, at a later time, V1/V2 heterozygous patients are considered for inclusion in this Arm of the trial, these patients will require to be centrally confirmed with at least one V1 allele.
Patients with histologically or cytologically documented advanced/metastatic primary or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC), melanoma, Non-Small Cell Lung Cancer (NSCLC) who failed or are not eligible to standard therapy
Patients with at least one measurable lesion are allowed as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Patient must have at least one Positron Emission Tomography (PET) imageable and evaluable tumor lesion with a diameter of at least 20 millimeter Further inclusion criteria apply.

Who cannot join

Patients with symptomatic/active central nervous system (CNS) metastases; patients with previously treated brain metastases are eligible if there is no evidence of progression for at least 28 days before the first study treatment administration, as ascertained by clinical examination and brain imaging (Magnetic Resonance Imaging (MRI) or Computed Tomography (CT)) during the screening period
Other tumor location necessitating an urgent therapeutic intervention (e.g., palliative care, surgery or radiation therapy, such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture)
Presence of other active invasive cancers other than the one treated in this trial within 5 years prior to screening (or less, pending discussion with sponsor), except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment
Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment (i.e. corticosteroids or immunosuppressive drugs); except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible
Known severe infusion related reactions to monoclonal antibodies (Grade ≥ 3 National Cancer Institute (NCI)- Common Terminology Criteria for Adverse Events (CTCAE) v5.0) and patients removed from previous anti-Programmed-cell-death-protein-1 (PD-1) or anti-Programmed-cell-death ligand-1 (PD-L1) therapy because of a severe or life-threatening immune-related adverse event (irAE) (Grade ≥ 3 NCI-CTCAE v5.0)
Patients receiving systemic treatment with any immunosuppressive medication within one-week prior to treatment start with SIRPα antibody (BI 765063 or BI 770371) and ezabenlimab; steroids of max. 10 mg prednisolone equivalent per day are allowed, topical and inhaled steroids are not considered as immunosuppressive
Patients who have interstitial lung disease or active, non-infectious pneumonitis.
Patients with uncontrolled disease-related metabolic disorders (e.g., hypercalcemia, Syndrome of Inappropriate of AntiDiuretic Hormone Secretion (SIADH)) or uncontrolled diabetes Further exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

VU University Medical Center
Amsterdam, 1081HV

Other trials in Netherlands

About this study

Official title: 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

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)
Being tested: BI 765063, Ezabenlimab, [89Zr]Zr- BI 765063, BI 770371, [89Zr]Zr- BI 770371
Medical subject headings: Carcinoma, Squamous Cell Carcinoma of Head and Neck, Melanoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 765063Drug
BI 765063
EzabenlimabDrug
Ezabenlimab
[89Zr]Zr- BI 765063Drug
[89Zr]Zr- BI 765063, specifically radiolabelled for immune-Positron Emission Tomography (PET)
BI 770371Drug
BI 770371
[89Zr]Zr- BI 770371Drug
[89Zr]Zr- BI 770371, specifically radiolabelled for immune-PET

Study groups in NCT05068102
Study group	Role	What they receive
Arm A	Experimental	Not described Receives: Drug: BI 765063; Drug: Ezabenlimab; Drug: [89Zr]Zr- BI 765063
Arm B	Experimental	Not described Receives: Drug: Ezabenlimab; Drug: BI 770371; Drug: [89Zr]Zr- BI 770371

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: up to 33 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 202225 Nov 2026

First posted5 Oct 2021
Study start3 Mar 2022
Primary completion22 Jan 2026
Study completion25 Nov 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Carcinoma, Squamous Cell of Head and Neck (HNSCC)Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: The trial is divided in 2 parts: In Part 1 of each arm, the patients will be entered sequentially. After review of Part 1 data for each arm, the Data Review Committee (DRC) will make the decision whether or not to initiate Part 2 for each arm. Patients entered in Part 2 will be treated in various dose cohorts of BI 765063 (Arm A) or BI 770371 (Arm B) at Cycle 2 and these dose cohorts will be managed sequentially based on the DRC decision.
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05068102
Sponsor's protocol ID: 1443-0003
Other IDs: 2021-001063-25
Status last verified: Sep 2026
First submitted: 19 Sep 2021
Last updated: 30 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingPhase 2
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All Carcinoma, Squamous Cell of Head and Neck (HNSCC) trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05068102
Acronym / sponsor ID: 1443-0003
Conditions: Carcinoma, Squamous Cell of Head and Neck (HNSCC), Melanoma, Non-small Cell Lung Cancer (NSCLC)
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 14 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 3 Mar 2022 (actual)
Primary completion: 22 Jan 2026 (actual)
Study completion: 25 Nov 2026 (estimated)
First posted: 5 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: The trial is divided in 2 parts: In Part 1 of each arm, the patients will be entered sequentially. After review of Part 1 data for each arm, the Data Review Committee (DRC) will make the decision whether or not to initiate Part 2 for each arm. Patients entered in Part 2 will be treated in various dose cohorts of BI 765063 (Arm A) or BI 770371 (Arm B) at Cycle 2 and these dose cohorts will be managed sequentially based on the DRC decision.

Arm	Type	Receives
Arm A	Experimental	Drug: BI 765063, Drug: Ezabenlimab, Drug: [89Zr]Zr- BI 765063
Arm B	Experimental	Drug: Ezabenlimab, Drug: BI 770371, Drug: [89Zr]Zr- BI 770371

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Signed and dated, written informed consent form (ICF) prior to any trial-specific procedures
Male or female aged ≥ 18 years (no upper limit of age) at the time of ICF signature
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of at least 3 months
For Arm A, only patients with a Signal Regulatory Protein-alpha (SIRPα) polymorphism V1/V1 will be eligible; SIRPα polymorphism will be assessed in blood sampling (patient deoxyribonucleic acid (DNA)) in a central laboratory; V1 allele is understood to include V1 and potential V1-like alleles. If, at a later time, V1/V2 heterozygous patients are considered for inclusion in this Arm of the trial, these patients will require to be centrally confirmed with at least one V1 allele.

Key exclusion criteria (8 listed)

Patients with symptomatic/active central nervous system (CNS) metastases; patients with previously treated brain metastases are eligible if there is no evidence of progression for at least 28 days before the first study treatment administration, as ascertained by clinical examination and brain imaging (Magnetic Resonance Imaging (MRI) or Computed Tomography (CT)) during the screening period
Other tumor location necessitating an urgent therapeutic intervention (e.g., palliative care, surgery or radiation therapy, such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture)
Presence of other active invasive cancers other than the one treated in this trial within 5 years prior to screening (or less, pending discussion with sponsor), except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment
Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment (i.e. corticosteroids or immunosuppressive drugs); except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible
Known severe infusion related reactions to monoclonal antibodies (Grade ≥ 3 National Cancer Institute (NCI)- Common Terminology Criteria for Adverse Events (CTCAE) v5.0) and patients removed from previous anti-Programmed-cell-death-protein-1 (PD-1) or anti-Programmed-cell-death ligand-1 (PD-L1) therapy because of a severe or life-threatening immune-related adverse event (irAE) (Grade ≥ 3 NCI-CTCAE v5.0)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 765063BI 765063	Drug	Arm A
EzabenlimabEzabenlimab	Drug	Arm A, Arm B
[89Zr]Zr- BI 765063[89Zr]Zr- BI 765063, specifically radiolabelled for immune-Positron Emission Tomography (PET)	Drug	Arm A
BI 770371BI 770371	Drug	Arm B
[89Zr]Zr- BI 770371[89Zr]Zr- BI 770371, specifically radiolabelled for immune-PET	Drug	Arm B

Primary outcome

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)
Time frame: 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)
Time frame: up to 33 months
peak SUVs are measured via Positron Emission Tomography (PET) scan

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: up to 33 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05068102.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.