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)

  • End date
    Jul 27, 2024
  • participants needed
  • sponsor
    Boehringer Ingelheim
Updated on 28 October 2022


This study is open to adults with head and neck cancer or liver cancer. 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 in people with head and neck cancer or liver cancer. 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. All participants get BI 765063 and ezabenlimab. One group gets no additional medicine. The other groups get either BI 836880, cetuximab, or chemotherapy. 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. The doctors monitor the size of the tumour. The doctors also regularly check participants' health and take note of any unwanted effects.

Condition Head and Neck Squamous Cell Carcinoma (HNSCC)
Treatment Cetuximab, BI 836880, BI 765063, ezabenlimab, Investigator´s Choice Chemotherapy
Clinical Study IdentifierNCT05249426
SponsorBoehringer Ingelheim
Last Modified on28 October 2022


Yes No Not Sure

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). 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 from the most recent time point before entering the
trial must be provided (maximum 6 months prior to study entry)
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 7 days 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) 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
Further inclusion criteria apply

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 and peripheral deep vein thrombosis)
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
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