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

NCT05068102 | Active Not Recruiting Phase 1

• 2 other identifiers: 1443-00032021-001063-25
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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)

  peak SUVs are measured via Positron Emission Tomography (PET) scan

  up to 33 months

• 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)

  peak SUVs are measured via Positron Emission Tomography (PET) scan

  up to 33 months

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: BI 765063; Drug: Ezabenlimab; Drug: [89Zr]Zr- BI 765063

Arm B

EXPERIMENTAL

Drug: Ezabenlimab; Drug: BI 770371; Drug: [89Zr]Zr- BI 770371

Interventions

BI 765063 DRUG

BI 765063

Arm A

Ezabenlimab DRUG

Ezabenlimab

Arm A; Arm B

[89Zr]Zr- BI 765063 DRUG

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

Arm A

BI 770371 DRUG

BI 770371

Arm B

[89Zr]Zr- BI 770371 DRUG

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

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

VU University Medical Center

Amsterdam, 1081HV, Netherlands

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma; Squamous Cell Carcinoma of Head and Neck; Melanoma; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Neoplasms by Site; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The trial is divided in 2 parts: In Part 1 of each arm, the patients will be entered sequentially. After review of Part 1 data for each arm, the Data Review Committee (DRC) will make the decision whether or not to initiate Part 2 for each arm. Patients entered in Part 2 will be treated in various dose cohorts of BI 765063 (Arm A) or BI 770371 (Arm B) at Cycle 2 and these dose cohorts will be managed sequentially based on the DRC decision.

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: October 5, 2021
• Study Start: March 3, 2022
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): August 6, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)