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

Get Involved

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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:

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05068102
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Boehringer Ingelheim
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Carcinoma, Squamous Cell of Head and Neck (HNSCC), Melanoma, Non-small Cell Lung Cancer (NSCLC)
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Arm A

Experimental: Arm B

Interventions

Drug: - BI 765063

BI 765063

Drug: - Ezabenlimab

Ezabenlimab

Drug: - [89Zr]Zr- BI 765063

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

Drug: - BI 770371

BI 770371

Drug: - [89Zr]Zr- BI 770371

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.