A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab

Advanced Solid Tumor Clinical Trial

Official title:

A First-in-Human Study of 89Zr-DFO-REGN5054 (Anti-CD8) Positron Emission Tomography in Patients With Solid Malignancies Treated With Cemiplimab

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259709
• Other study ID #: R5054-ONC-1843
• Secondary ID: 2019-001604-38
• Status: Recruiting
• Phase: Phase 1
• Start date: February 7, 2023
• Est. completion date: September 17, 2026

Study information

• Verified date: September 2023
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 your 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 your 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 17, 2026
• Est. primary completion date: September 17, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Neoplasms

Intervention

Drug:
• 89Zr?DFO?REGN5054
Administered by intravenous (IV) infusion during Part A and B.
• cemiplimab
Administered by IV infusion every 3 weeks (Q3W).

Locations

Country	Name	City	State
Netherlands	UMC Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of treatment-emergent adverse events (TEAEs)	Part A	Up to day 8, after the infusion of 89Zr?DFO?REGN5054
Primary	Incidence and severity of TEAEs	Part A and B	Up to approximately week 115
Secondary	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	On days 1, 5 and 8
Secondary	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.	On days 1, 5 and 8
Secondary	Concentration of 89Zr-DFO-REGN5054 in serum	Part A	On days 1, 5 and 8
Secondary	Serum imaging agent activity concentration of area under the curve (AUC0-7)	Part A	Up to day 8
Secondary	89Zr-DFO-REGN5054 uptake across cluster of differentiation 8 (CD8)-expressing normal tissues and tumors	Part A and Part B	At the time of imaging, up to day 8
Secondary	Blood pool uptake of 89Zr-DFO-REGN5054 with subsequent calculation of standardized uptake value (SUV) tumor-to-blood ratios	Part A and Part B	At the time of imaging, up to day 8
Secondary	Association of 89Zr?DFO?REGN5054 autoradiographic signal intensity distribution with CD8 expression in tumor tissues	Part A and Part B	At Baseline
Secondary	Association of 89Zr-DFO-REGN5054 uptake with CD8 expression in tumor tissues	Part B	At Baseline
Secondary	Association of tumor-to-blood ratio of 89Zr-DFO-REGN5054 with CD8 expression in tumor tissues	Part B	At Baseline