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Active, not recruitingNCT05068102Updated Sep 30, 2026

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 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

Updated Sep 30, 2026Study completion movedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Carcinoma, Squamous Cell of Head and Neck (HNSCC)
  • Melanoma
  • Non-small Cell Lung Cancer (NSCLC)
03

In context

Carcinoma

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Arm A

    Drug: BI 765063 · Drug: Ezabenlimab · Drug: [89Zr]Zr- BI 765063

  • Experimental
    Arm B

    Drug: Ezabenlimab · Drug: BI 770371 · Drug: [89Zr]Zr- BI 770371

Interventions

  • DrugBI 765063

    BI 765063

  • DrugEzabenlimab

    Ezabenlimab

  • Drug[89Zr]Zr- BI 765063

    \[89Zr\]Zr- BI 765063, specifically radiolabelled for immune-Positron Emission Tomography (PET)

  • DrugBI 770371

    BI 770371

  • Drug[89Zr]Zr- BI 770371

    \[89Zr\]Zr- BI 770371, specifically radiolabelled for immune-PET

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Study locations

1 site
  • VU University Medical Center
    Amsterdam, 1081HV, Netherlands
08

References and documents

Related links

Individual participant data

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

09

Updates

1 registry update since Sep 25, 2026
Study completion
Jul 14, 2027→Nov 25, 2026
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Study completion Jul 14, 2027→Nov 25, 2026
    + 1 other change: verification date

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 ↗

10

Registry details

Key details

Study ID
NCT05068102
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 5, 2021
Start date
Mar 3, 2022
Primary completion
Jan 22, 2026
Completion
Nov 25, 2026 (estimated)
Last update
Sep 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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