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

Conditions: Head and neck cancer
lung cancer
skincancer
10027655

Registration Number: NL-OMON51904

Lead Sponsor: IQVIA RDS Netherlands B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 22

Inclusion Criteria

1. Signed and dated, written informed consent form (ICF) prior to any
trial-specific procedures 2. Male or female aged >= 18 years (no upper limit of
age) at the time of ICF signature 3. Eastern Cooperative Oncology Group (ECOG)
performance status of 0 or 1 4. Life expectancy of at least 3 months 5. For Arm
A, only patients with a SIRPa polymorphism V1/V1 will be eligible; SIRPa
polymorphism will be assessed in blood sampling (patient 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. 6. Patients with histologically or
cytologically documented advanced/metastatic primary or recurrent HNSCC,
melanoma, NSCLC who failed or are not eligible to standard therapy 7. Patients
with at least one measurable lesion are allowed as per RECIST v1.1 8. Patient
must have at least one PET imageable and evaluable tumor lesion with a diameter
of at least 20 mm 9. Patients must agree to on-treatment tumor biopsies
(optional for first 3 patients in Part 1). 10. Adequate biological parameters
defined as: • absolute neutrophil count (ANC) >= 1.5 x 109/L • hemoglobin (Hb)
level >= 9 g/dL (without recent red blood cell transfusion within 2 weeks prior
to study entry) • platelet count >= 100 x 109/L • total bilirubin level <= 1.5 x
Upper Limit Normal (ULN), except for patients with Gilbert's syndrome from whom
total bilirubin < 3.0 x ULN or direct bilirubin < 1.5 x ULN is authorized •
aspartate transaminase (AST) and alanine transaminase (ALT) <= 2.5x ULN • serum
creatinine <= 1.5 x ULN or creatinine clearance > 50 mL/min (Chronic Kidney
Disease Epidemiology [CKD-EPI] CKD-epi formula) • INR <= 1.5 (except if patient
treated with anti-vitamin K); anticoagulation with anti-vitamin K and low
molecular weight heparin [LMWH] is allowed 11. Prior major treatment-related
surgery completed at least 28 days before study drug administration 12.
Interval of at least 28 days or 5 half-lives (whichever is shorter) since the
last chemotherapy, approved immunotherapy, biological or investigational
therapy, radiation or tyrosine kinase inhibitor (TKI) therapy (e.g., sunitinib,
sorafenib) must have elapsed before the first study drug administration(s) (on
C1D1) and all toxicities related to previous anticancer therapies have resolved
to normal value or <= Grade 1 prior to the study treatment administration (on
C1D1), except alopecia 13. Male or female patients. Women of childbearing
potential (WOCBP) and men able to father a child must agree to use highly
effective methods of contraception (i.e. one that results in a less than 1% per
year failure rate when used consistently and correctly), prior to study entry,
during the study and for 5 months after the last dose of study drug. A list of
contraception methods meeting these criteria is provided in the patient
information. The requirement of contraception does not apply to women of no
childbearing potential and men not able to father a child, but they must have
an evidence of such at screening. 14. Females of childbearing potential must
have a serum negative pregnancy test within 7 days prior to first
administration. Females who

Exclusion Criteria

1. 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 (MRI
or CT) during the screening period 2. 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) 3. 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 4. 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 5. Known severe infusion related reactions to monoclonal
antibodies (Grade >= 3 NCI-CTCAE v5.0) and patients removed from previous
anti-PD-1 or anti-PD-L1 therapy because of a severe or life-threatening
immune-related adverse event (irAE) (Grade >= 3 NCI-CTCAE v5.0); 6. Patients
receiving systemic treatment with any immunosuppressive medication within
one-week prior to treatment start with SIRPa antibody (BI 765063 or BI 770371)
and ezabenlimb; steroids of max. 10 mg prednisolone equivalent per day are
allowed, topical and inhaled steroids are not considered as immunosuppressive
7. Patients who have interstitial lung disease or active, non-infectious
pneumonitis. 8. Patients with uncontrolled disease-related metabolic disorders
(e.g., hypercalcemia, SIADH) or uncontrolled diabetes 9. Patients with
uncontrolled congestive heart failure defined as New York Heart Association
(NYHA) class III or IV, uncontrolled hypertension, unstable heart disease
(e.g., coronary artery disease with unstable angina or myocardial infarction
within 6 months before study treatment administration) 10. Patients with
significant ECG abnormalities defined as any cardiac dysrhythmia (> Grade 2)
(i.e., significant ventricular arrhythmia as persistent ventricular tachycardia
and/or ventricular fibrillation; severe conduction disorders as
atrio-ventricular block 2 and 3, sino-atrial block) or baseline QT/QTc interval
>480 milliseconds (ms) 11. Patients with significant chronic liver disease
(e.g., significant fibrosis, known cirrhosis) or active HBV or HCV infection;
if HbsAg positive, an effective antiviral treatment to prevent hepatitis B
reactivation is recommended 12. Patients with known Human Immunodeficiency
Virus (HIV) infection or patients with an active infection requiring specific
anti-infective therapy until all signs of infection have resolved, and this
within 2 weeks prior to the first study treatment administ

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Relative change from baseline (Cycle 1, up to Day 7) of peak Standardized<br /><br>Uptake Values (SUVs) of [89Zr]Zr-BI 765063 (arm A) or [89Zr]Zr-BI 770371 (arm<br /><br>B) in up to five target lesions at post BI 765063 (arm A) or BI 770371 (arm B)<br /><br>treatment scanning time points (Cycle 2, up to Day 7).</p><br>

Secondary Outcome Measures