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

Launched by BOEHRINGER INGELHEIM · Sep 23, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how two medicines, BI 765063 and BI 770371, are taken up by tumors in adults with advanced types of cancer, such as head and neck cancer, melanoma, or non-small cell lung cancer. These participants will also receive a third medicine called ezabenlimab, which helps the immune system fight cancer. The study aims to learn how well these medicines work together and how they are distributed in the body. Participants will receive infusions of either BI 765063 or BI 770371 every three weeks, and doctors will use special imaging scans to track how these medicines are affecting the tumors.

To join this study, participants need to be adults aged 18 or older who have advanced cancer that has not responded to standard treatments. They must also have at least one measurable tumor and a life expectancy of at least three months. Throughout the study, doctors will monitor participants' health and any side effects they may experience. It's important to note that this study is currently recruiting participants, and those who benefit from the treatment can remain in the study as long as they can tolerate it.

Gender

ALL

Eligibility 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.