A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
89Zr˗DFO˗REGN5054
DrugAdministered by intravenous (IV) infusion during Part A and B.
cemiplimab
DrugAdministered by IV infusion every 3 weeks (Q3W).
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Single ascending dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimabExperimental treatment 2 interventions
Group B: Defined dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence and severity of treatment-emergent adverse events (TEAEs)
Part A
Time frame
Up to day 8, after the infusion of 89Zr˗DFO˗REGN50542
Incidence and severity of TEAEs
Part A and B
Time frame
Up to approximately week 115Secondary outcomes
1
Clinical dosimetry based on tissue radiation absorbed dose calculated from positron emission tomography (PET) image acquisition data
After injection of 37 megabecquerel (MBq) of 89Zr-DFO-REGN5054, a series of whole-body positron emission tomography (PET) images will be obtained over a period of up to 8 days and corrected for attenuation by low-dose computed tomography (CT) scans using PET/CT. The radiation effective dose per organ/tissue will be calculated for each organ using Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA/EXM). The unit of effective dose per organ/tissue will be millisievert per Minimum Base Quantity (MBq) for each participant's organ/tissue. The final values for each organ will be averaged across participants for each mass dose
Time frame
On days 1, 5 and 82
Clinical dosimetry based on tissue radiation effective dose calculated from PET image acquisition data
After injection of 37 MBq of 89Zr-DFO-REGN5054, a series of whole-body PET images will be obtained over a period of up to 8 days and corrected for attenuation by low-dose CT scans using PET/CT. The radiation effective dose for the whole body will be calculated using OLINDA/EXM software. The unit of effective dose will be millisievert per MBq for the whole body for each participant. The final values will be averaged across participants for each mass dose.
Time frame
On days 1, 5 and 83
Concentration of 89Zr-DFO-REGN5054 in serum
Part A
Time frame
On days 1, 5 and 84
Serum imaging agent activity concentration of area under the curve (AUC0-7)
Part A
Time frame
Up to day 8Sponsors and contacts
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Source ClinicalTrials.gov