Clinical trial NCT05259709: A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab
Official title: A First-in-Human Study of 89Zr-DFO-REGN5054 (Anti-CD8) Positron Emission Tomography in Patients With Solid Malignancies Treated With Cemiplimab
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Metastatic Solid Tumor
Keywords: Positron Emission Tomography (PET) scan
Immuno-PET
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is researching an experimental drug called 89Zr-DFO-REGN5054 and cemiplimab. The study is focused on patients with a type of cancer that can be potentially imaged using 89Zr-DFO-REGN5054 and show special tumor features that may be important to the way the immune system fights cancer.

The aim of the study is to study the safety and tolerability (how the body reacts to the drug) of the imaging agent 89Zr-DFO REGN5054.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drugs
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)


Eligibility criteria: Key Inclusion Criteria:

* Advanced or metastatic solid tumors that may respond to anti-programmed cell death 1 (PD-1) immunotherapy
* Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
* Adequate organ and bone marrow function as defined in the protocol
* Willing and able to comply with clinic visits and study-related procedures (including required tumor biopsy for Part B)

Key Exclusion Criteria:

* Currently receiving another cancer treatment or inadequate time since last therapy, as defined in the protocol
* Has not yet recovered from acute toxicities from prior therapy; exceptions defined in the protocol
* Prior treatment with a blocker of the PD-1/Programmed death ligand 1 (PD-L1) pathway
* Currently receiving or has received chimeric antigen receptor (CAR-T) cell therapy
* Symptomatic or untreated brain metastases, leptomeningeal disease, or spinal cord compression
* Known history of or any evidence of interstitial lung disease, active, noninfectious pneumonitis (past 5 years) or active tuberculosis

NOTE: Other protocol defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Incidence and severity of treatment-emergent adverse events (TEAEs)
timeFrame: Up to day 8, after the infusion of 89Zr˗DFO˗REGN5054
measure: Incidence and severity of TEAEs
timeFrame: Up to approximately week 115
Secondary outcomes:
measure: Clinical dosimetry based on tissue radiation absorbed dose calculated from positron emission tomography (PET) image acquisition data
timeFrame: On days 1, 5 and 8
measure: Clinical dosimetry based on tissue radiation effective dose calculated from PET image acquisition data
timeFrame: On days 1, 5 and 8
measure: Concentration of 89Zr-DFO-REGN5054 in serum
timeFrame: On days 1, 5 and 8
measure: Serum imaging agent activity concentration of area under the curve (AUC0-7)
timeFrame: Up to day 8
measure: 89Zr-DFO-REGN5054 uptake across cluster of differentiation 8 (CD8)-expressing normal tissues and tumors
timeFrame: At the time of imaging, up to day 8
measure: Blood pool uptake of 89Zr-DFO-REGN5054 with subsequent calculation of standardized uptake value (SUV) tumor-to-blood ratios
timeFrame: At the time of imaging, up to day 8
measure: Association of 89Zr˗DFO˗REGN5054 autoradiographic signal intensity distribution with CD8 expression in tumor tissues
timeFrame: At Baseline
measure: Association of 89Zr-DFO-REGN5054 uptake with CD8 expression in tumor tissues
timeFrame: At Baseline
measure: Association of tumor-to-blood ratio of 89Zr-DFO-REGN5054 with CD8 expression in tumor tissues
timeFrame: At Baseline
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMC Groningen
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trials Management
role: STUDY_DIRECTOR
References: