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

Phase 1

Recruiting

• Conditions: Carcinoma, Squamous Cell of Head and Neck (HNSCC); Non-small Cell Lung Cancer (NSCLC); Melanoma

• Registration Number: NCT05068102
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-9-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

<br><br> - Signed and dated, written informed consent form (ICF) prior to any trial-specific<br> procedures<br><br> - Male or female aged = 18 years (no upper limit of age) at the time of ICF signature<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1<br><br> - Life expectancy of at least 3 months<br><br> - For Arm A, only patients with a Signal Regulatory Protein-alpha (SIRPa) polymorphism<br> V1/V1 will be eligible; SIRPa polymorphism will be assessed in blood sampling<br> (patient deoxyribonucleic acid (DNA)) in a central laboratory; V1 allele is<br> understood to include V1 and potential V1-like alleles. If, at a later time, V1/V2<br> heterozygous patients are considered for inclusion in this Arm of the trial, these<br> patients will require to be centrally confirmed with at least one V1 allele.<br><br> - Patients with histologically or cytologically documented advanced/metastatic primary<br> or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC), melanoma, Non-Small Cell<br> Lung Cancer (NSCLC) who failed or are not eligible to standard therapy<br><br> - Patients with at least one measurable lesion are allowed as per Response Evaluation<br> Criteria In Solid Tumors (RECIST) v1.1<br><br> - Patient must have at least one Positron Emission Tomography (PET) imageable and<br> evaluable tumor lesion with a diameter of at least 20 millimeter Further inclusion<br> criteria apply.<br><br>Exclusion criteria:<br><br> - Patients with symptomatic/active central nervous system (CNS) metastases; patients<br> with previously treated brain metastases are eligible if there is no evidence of<br> progression for at least 28 days before the first study treatment administration, as<br> ascertained by clinical examination and brain imaging (Magnetic Resonance Imaging<br> (MRI) or Computed Tomography (CT)) during the screening period<br><br> - Other tumor location necessitating an urgent therapeutic intervention (e.g.,<br> palliative care, surgery or radiation therapy, such as spinal cord compression,<br> other compressive mass, uncontrolled painful lesion, bone fracture)<br><br> - Presence of other active invasive cancers other than the one treated in this trial<br> within 5 years prior to screening (or less, pending discussion with sponsor), except<br> appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of<br> uterine cervix, or other local tumors considered cured by local treatment<br><br> - Patients with active autoimmune disease or a documented history of autoimmune<br> disease, that requires systemic treatment (i.e. corticosteroids or immunosuppressive<br> drugs); except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or<br> any chronic skin condition that does not require systemic therapy, patients with<br> autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone<br> and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be<br> eligible<br><br> - Known severe infusion related reactions to monoclonal antibodies (Grade = 3 National<br> Cancer Institute (NCI)- Common Terminology Criteria for Adverse Events (CTCAE) v5.0)<br> and patients removed from previous anti-Programmed-cell-death-protein-1 (PD-1) or<br> anti-Programmed-cell-death ligand-1 (PD-L1) therapy because of a severe or<br> life-threatening immune-related adverse event (irAE) (Grade = 3 NCI-CTCAE v5.0)<br><br> - Patients receiving systemic treatment with any immunosuppressive medication within<br> one-week prior to treatment start with SIRPa antibody (BI 765063 or BI 770371) and<br> ezabenlimab; steroids of max. 10 mg prednisolone equivalent per day are allowed,<br> topical and inhaled steroids are not considered as immunosuppressive<br><br> - Patients who have interstitial lung disease or active, non-infectious pneumonitis.<br><br> - Patients with uncontrolled disease-related metabolic disorders (e.g., hypercalcemia,<br> Syndrome of Inappropriate of AntiDiuretic Hormone Secretion (SIADH)) or uncontrolled<br> diabetes Further exclusion criteria apply.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arm A: Relative change from baseline (Cycle 1, up to Day 7) of peak Standardized Uptake Values (SUVs) of [89Zr]Zr-BI 765063 in up to five target lesions at post BI 765063 treatment scanning time points (Cycle 2, up to Day 7);Arm B: Relative change from baseline (Cycle 1, up to Day 7) of peak Standardized Uptake Values (SUVs) of [89Zr]Zr-BI 770371 in up to five target lesions at post BI 770371 treatment scanning time points (Cycle 2, up to Day 7)