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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 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

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)

NCT05249426•Boehringer Ingelheim

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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).
•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:
+8 more criteria

Exclusion Criteria

•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.
•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).

Locations (25)

Valkyrie Clinical Trials

Los Angeles, California, United States

CTR Georges-François Leclerc

Dijon, France

CTR Leon Berard

Lyon, France

HOP Timone

Marseille, France

INS Curie

Paris, France

HOP Civil

Strasbourg, France

INS Claudius Regaud IUCT-Oncopole

Toulouse, France

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, Japan

Hospital Sultan Ismail

Johor Bahru, Malaysia

Sarawak General Hospital

Kuching, Sarawak, Malaysia

Key Dates

Start Date

April 12, 2022

Primary Completion Date

July 15, 2024

Completion Date

July 31, 2026

Last Updated

January 21, 2026

Enrollment

ACTUAL participants

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

BI 765063

DRUG

Ezabenlimab

DRUG

BI 836880

DRUG

Cetuximab

DRUG

Investigator´s Choice Chemotherapy

OTHER

Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

NCT04080804

Head and Neck Squamous Cell Carcinoma (HNSCC)

View study

RECRUITINGNA

Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

NCT06630780

Head and Neck Squamous Cell Carcinoma (HNSCC)

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RECRUITINGPHASE1/PHASE2

AK129 Combination Therapy for Advanced Solid Tumors

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

AK129 Combination Therapy for Advanced Solid Tumors

A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers

A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma