Testing how two medicines are absorbed in tumors of patients with advanced cancer
An Open Label Phase I PET Imaging Study to Investigate the Bio-distribution and Tumor Uptake of [89Zr]Zr-BI 765063 and [89Zr]Zr-BI 770371 in Patients With Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer or Melanoma Who Are Treated With Ezabenlimab
This study is testing how well two medicines work in tumors for adults with advanced head and neck cancer, melanoma, or lung cancer that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boehringer Ingelheim Industry-sponsored |
| Drugs / interventions | ezabenlimab, radiation |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05068102 on ClinicalTrials.gov |
What this trial studies
This study involves adults with advanced head and neck cancer, melanoma, or non-small cell lung cancer who have not responded to previous treatments. It aims to investigate how two medications, BI 765063 and BI 770371, are taken up by tumors and distributed in the body when combined with ezabenlimab, an immune checkpoint inhibitor. Participants will receive these treatments via infusion every three weeks, and imaging methods like PET/CT scans will be used to monitor the uptake of the medications in the tumors. The study will continue as long as participants benefit from the treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced head and neck squamous cell carcinoma, melanoma, or non-small cell lung cancer who have failed prior treatments.
Not a fit: Patients who are not eligible include those with a different type of cancer or those who have not failed previous treatments.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how these therapies work and improve treatment options for patients with advanced cancers.
How similar studies have performed: Other studies have shown promise with similar immune checkpoint inhibitors, suggesting potential for success in this approach.
Eligibility criteria
Show full 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.
Where this trial is running
Amsterdam
- VU University Medical Center — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Boehringer Ingelheim
- Email: clintriage.rdg@boehringer-ingelheim.com
- Phone: 1-800-243-0127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.