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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor; Metastatic Solid Tumor
• Interventions: Drug: 89Zr˗DFO˗REGN5054; Drug: cemiplimab

• Registration Number: NCT05259709
• Lead Sponsor: Regeneron Pharmaceuticals

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-02-28
• Study Start: 2023-02-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-07-28
• Study Completion: 2025-07-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Defined dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab	89Zr˗DFO˗REGN5054	Part B: Defined dose of 89Zr˗DFO˗REGN5054 determined in Part A.
Defined dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab	cemiplimab	Part B: Defined dose of 89Zr˗DFO˗REGN5054 determined in Part A.
Single ascending dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab	89Zr˗DFO˗REGN5054	Part A: Doses of 89Zr˗DFO˗REGN5054 may be reduced based upon assessment.
Single ascending dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab	cemiplimab	Part A: Doses of 89Zr˗DFO˗REGN5054 may be reduced based upon assessment.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of treatment-emergent adverse events (TEAEs)	Up to day 8, after the infusion of 89Zr˗DFO˗REGN5054	Part A
Incidence and severity of TEAEs	Up to approximately week 115	Part A and B

Secondary Outcome Measures

Name	Time	Method
Concentration of 89Zr-DFO-REGN5054 in serum	On days 1, 5 and 8	Part A
Serum imaging agent activity concentration of area under the curve (AUC0-7)	Up to day 8	Part A
Blood pool uptake of 89Zr-DFO-REGN5054 with subsequent calculation of standardized uptake value (SUV) tumor-to-blood ratios	At the time of imaging, up to day 8	Part A and Part B
89Zr-DFO-REGN5054 uptake across cluster of differentiation 8 (CD8)-expressing normal tissues and tumors	At the time of imaging, up to day 8	Part A and Part B
Association of 89Zr˗DFO˗REGN5054 autoradiographic signal intensity distribution with CD8 expression in tumor tissues	At Baseline	Part A and Part B
Association of tumor-to-blood ratio of 89Zr-DFO-REGN5054 with CD8 expression in tumor tissues	At Baseline	Part B
Clinical dosimetry based on tissue radiation effective dose calculated from PET image acquisition data	On days 1, 5 and 8	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.
Clinical dosimetry based on tissue radiation absorbed dose calculated from positron emission tomography (PET) image acquisition data	On days 1, 5 and 8	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
Association of 89Zr-DFO-REGN5054 uptake with CD8 expression in tumor tissues	At Baseline	Part B

Trial Locations

Locations (1)

UMC Groningen; 🇳🇱 Groningen, Netherlands