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Head and Neck Squamous Cell Carcinoma (HNSCC)Phase 1NCT05249426

A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer

A Phase 1 study testing BI 765063, Ezabenlimab and BI 836880 in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by Boehringer Ingelheim at 25 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

With an amendment of the protocol, this study is only open to adults with head and neck cancer. Previously also adults with liver cancer joined. This is a study for people for whom previous treatment was not successful or no standard treatment exists. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BI 765063, Ezabenlimab and BI 836880
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
25 sitesin 11 countries
Study dates
12 Apr 2022to 22 Jun 2026
Phase
Phase 1
Are there results?
None posted in the registry

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 informed consent form (ICF) prior to any trial-specific procedures.
  • Male or female aged ≥ 18 years at the time of ICF signature.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the screening visit.
  • Expected life expectancy of at least 3 months.
  • Patients homozygous for V1 allele (including V1-like alleles) of Singal Regulatory Protein-alpha (SIRPα) (V1/V1 SIRPα genotype). SIRPα polymorphism will be assessed in blood sampling (using patient Deoxyribonucleic Acid [DNA]) during Screening 1 Visit.
  • Patients with at least one measurable lesion as per Response Evaluation Critiera In Solid Tumours (RECIST) version 1.1 (v1.1).
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  • Patients must agree to provide a mandatory pre-treatment (baseline) biopsy and an ontreatment fresh tumour biopsy (unless medically contraindicated. or mandatory requirement is lifted by the sponsor). Details on biopsy sample collection are provided in the Lab Manual.
  • -- Pre-treatment (baseline) biopsy: A fresh tumour biopsy before receiving the trial medication is preferred. In case a fresh tumour biopsy cannot be obtained, the Sponsor must be notified and archival formalin-fixed paraffin embedded (FFPE) tumour tissue block from the most recent time point before entering the trial must be provided (maximum 6 months prior to study entry). If these requirements cannot be met, the patient may still be allowed to enter the study at the discretion of the sponsor, after discussion between the Investigator and Sponsor.
  • Female patients. Women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception per ICH M3 (R2), that results in a less than 1% per year failure rate when used consistently and correctly, starting at the screening visit, during the trial and for 6 months after the end of trial treatment. The requirement of contraception does not apply to women of no childbearing potential, but they must have evidence of such at screening. Women of childbearing potential must have a serum negative pregnancy test within 72 hours prior to first drug administration.
  • Women who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test. The following methods of contraception are considered highly effective:
  • Combined (oestrogen and progestogen containing) hormonal birth control that prevents ovulation (oral, intravaginal, transdermal)
  • Progestogen-only hormonal birth control that prevents ovulation (oral, injectable, implantable)
  • Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
  • Bilateral tubal occlusion
  • Vasectomised partner (provided that this is the sole sexual partner and has received medical assessment of the surgical success)
  • Sexual abstinence (if accepted by local ethics boards and regulatory agencies as highly effective) Sexual abstinence is defined as refraining from heterosexual intercourse during the entire study period from screening through 6 months after last trial treatment. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
  • Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not an acceptable method of contraception for use during this trial.
  • Although use of a contraceptive pill and Intrauterine device (IUD) together are considered a highly- effective method of birth control, women of childbearing potential taking a contraceptive pill must use an additional barrier method for the entire duration of the trial treatment intake and for 6 months after the end of the trial treatment intake. WOCBP is defined as: fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
  • Further inclusion criteria apply.

Who cannot join

  • Patients with at least one SIRPα V2 allele, i.e. SIRPα V1/V2 or V2/V2 individuals.
  • 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 trial drug administration without requirement for treatment with corticosteroids, as ascertained by clinical examination and brain imaging (MRI (magnetic resonance imaging) or CT (computed tomography)) during the screening period.
  • Prior allogeneic stem cell or solid organ transplantation.
  • Any tumour 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 active invasive cancers other than the one treated in this trial within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumours 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 are eligible.
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  • History of severe hemorrhagic or thromboembolic event in the past 12 months (excluding central venous catheter thrombosis, peripheral deep vein thrombosis and portal vein thrombosis due to HCC tumor invasion).
  • Known prior history of severe infusion related reactions to monoclonal antibodies (Grade ≥ 3 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events (CTCAE) v5.0).
  • Further exclusion criteria apply.

Trial locations and contacts

25 sites in 11 countries.

25 sites in 11 countries

France6 sites

  • CTR Georges-François Leclerc

    Dijon, 21079

  • CTR Leon Berard

    Lyon, 69373

  • HOP Timone

    Marseille, 13385

  • INS Curie

    Paris, 75248

  • HOP Civil

    Strasbourg, 67091

  • INS Claudius Regaud IUCT-Oncopole

    Toulouse, 31059

Other trials in France

Mexico3 sites

  • ARKE SMO S.A. de C.V

    Mexico City, 06700

  • FAICIC S de RL de C.V.

    Veracruz, 91900

  • Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V.

    Zapopan, 45070

Other trials in Mexico

Spain3 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08907

  • Hospital Clínico San Carlos

    Madrid, 28040

Other trials in Spain

United Kingdom3 sites

  • King's College Hospital

    London, SE5 9RS

  • The Royal Marsden Hospital, Chelsea

    London, SW3 6JJ

  • Hammersmith Hospital

    London, W12 0HS

Other trials in United Kingdom

Malaysia2 sites

  • Hospital Sultan Ismail

    Johor Bahru, 81100

  • Sarawak General Hospital

    Kuching, Sarawak, 93586

Other trials in Malaysia

Romania2 sites

  • "Prof. Dr. Alexandru Trestioreanu" Oncology Institut

    Bucharest, 022328

  • Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015

Other trials in Romania

Thailand2 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

United States1 site

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

Other trials in United States

Japan1 site

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550

Other trials in Japan

Moldova1 site

  • ARENSIA Exploratory Medicine

    Chisinau, MD-2025

Other trials in Moldova

Poland1 site

  • Mandziuk Slawomir Specialist Medical Practice

    Lublin, 20-093

Other trials in Poland

About this study

Official title: An Open Label Trial of BI 765063 in Combination With BI 754091 (Ezabenlimab) Alone or With BI 836880, Chemotherapy, or Cetuximab, in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) or Hepatocellular Carcinoma (HCC)

With an amendment of the protocol, this study is only open to adults with head and neck cancer. Previously also adults with liver cancer joined. This is a study for people for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out whether combining different medicines make tumours shrink.

The tested medicines in this study are antibodies that act in different ways against cancer. BI 765063 and ezabenlimab may help the immune system fight cancer (checkpoint inhibitors). Cetuximab blocks growth signals and may prevent the tumour from growing. BI 836880 blocks the formation of new blood vessels that the tumour needs to grow.

With amendments of the protocol, all participants receive cetuximab in addition to BI 765063 and ezabenlimab. Ezabenlimab treatment and any other assigned treatment are given no longer than 2 years. Previously, BI 765063 and ezabenlimab were also given alone, or in combination with chemotherapy, or with BI 836880. BI 765063, ezabenlimab, and BI 836880 are given as infusions into veins every 3 weeks. Cetuximab is given as an infusion every 1 or 2 weeks. Participants can stay in the study as long as they benefit from treatment and can tolerate it. They regularly visit the study site where doctors check participants' health and take note of any unwanted effects. The doctors also monitor the size of the tumour.

Being tested
BI 765063, Ezabenlimab, BI 836880, Cetuximab, Investigator´s Choice Chemotherapy
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • BI 765063Drug

    BI 765063 (anti-Signal Regulatory Protein Alpha (SIRPα) Monoclonal Antibody (mAb))

  • EzabenlimabDrug

    Also called BI 754091

    Ezabenlimab (anti-Programmed cell death protein 1 (PD-1) Monoclonal Antibody (mAb))

  • BI 836880Drug

    BI 836880 (anti-Vascular Endothelial Growth Factor (VEGF) / Angiopoetin 2 (Ang2))

  • CetuximabDrug

    Cetuximab

  • Investigator´s Choice ChemotherapyOther

    Allowable chemotherapies include: paclitaxel, docetaxel, capecitabine, 5-fluorouracil, methotrexate or combinations thereof

Study groups in NCT05249426
Study groupRoleWhat they receive
Cohort A: BI 765063 + ezabenlimab + cetuximabExperimental30 Signal Regulatory Protein Alpha (SIRPα) V1/V1 homozygous patients with 2nd line recurrent/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) who had received prior platinum-based therapy within the recurrent/metastatic setting.
Receives: Drug: BI 765063; Drug: Ezabenlimab; Drug: Cetuximab
Cohort B: BI 765063 + ezabenlimab + chemo (invest choice)Experimental30 SIRPα V1/V1 homozygous patients with 2nd line recurrent/metastatic HNSCC who had received prior platinum-based therapy within the recurrent/metastatic setting.
Receives: Drug: BI 765063; Drug: Ezabenlimab; Other: Investigator´s Choice Chemotherapy
Cohort C: BI 765063 + ezabenlimabExperimental30 SIRPα V1/V1 homozygous patients with advanced or metastatic 1st line Hepatocellular Carcinoma (HCC).
Receives: Drug: BI 765063; Drug: Ezabenlimab
Cohort D: BI 765063 + ezabenlimab + BI 836880Experimental30 SIRPα V1/V1 homozygous patients with advanced or metastatic 1st line HCC.
Receives: Drug: BI 765063; Drug: Ezabenlimab; Drug: BI 836880
Cohort E: BI 765063 + ezabenlimab + BI 836880Experimental30 SIRPα V1/V1 homozygous patients with advanced or metastatic 2nd line HCC who progressed on therapy with atezolizumab in combination with bevacizumab.
Receives: Drug: BI 765063; Drug: Ezabenlimab; Drug: BI 836880

What is being measured

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

  1. Objective Response (OR)

    Objective response (OR) with confirmation, defined as the best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1) by investigator's assessment from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent.

    Measured: Up to 24 months.

Secondary outcomes (4)

  1. Occurrence of treatment emergent adverse events (AEs)

    Occurrence of treatment emergent adverse events (AEs) by investigator's assessment from first treatment administration until the earliest of death, subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent.

    Measured: Up to 24 months.

  2. Duration of objective response (DOR)

    Duration of objective response (DOR), defined as the time from first documented complete response (CR) or partial response (PR) (RECIST v1.1) until the earliest of progressive disease (PD) or death among patients with objective response (OR).

    Measured: Up to 24 months.

  3. Disease control (DC)

    Disease control (DC), defined as best overall response of complete reponse (CR), partial reponse (PR), or stable disease (SD) where best overall response is defined according to RECIST v1.1 as assessed by the Investigator until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, or permanent treatment discontinuation.

    Measured: Up to 24 months.

  4. Progression-free survivial (PFS)

    Progression-free survival (PFS), defined as the time from first treatment administration until progressive disease (PD) according to RECIST v1.1 or death from any cause, whichever occurs earlier.

    Measured: Up to 24 months.

Timeline

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

  1. First posted21 Feb 2022
  2. Study start12 Apr 2022
  3. Primary completion15 Jul 2024
  4. Study completion22 Jun 2026

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05249426
Sponsor's protocol ID
1443-0002
Other IDs
2021-003473-59
Status last verified
Sep 2026
First submitted
10 Feb 2022
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
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, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 765063, Ezabenlimab and BI 836880 in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by Boehringer Ingelheim at 25 sites in 11 countries.

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 19 inclusion and 9 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: finished, as of the sponsor's last update on 16 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 25 sites in France, Mexico, Spain, United Kingdom, Malaysia and 6 more countries. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Objective Response (OR) (time frame: Up to 24 months.). 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 NCT05249426.

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 16 Sep 2026.

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