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

NCT05259709 | Recruiting Phase 1

• 3 other identifiers: R5054-ONC-18432019-001604-382024-515351-37-00
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

Advanced Solid Tumor; Metastatic Solid Tumor

Keywords

Positron Emission Tomography (PET) scan; Immuno-PET

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of treatment-emergent adverse events (TEAEs)

  Part A

  Up to day 8, after the infusion of 89Zr˗DFO˗REGN5054

• Incidence and severity of TEAEs

  Part A and B

  Up to approximately week 115

Secondary Outcomes (9)

• Clinical dosimetry based on tissue radiation absorbed dose calculated from positron emission tomography (PET) image acquisition data

  On days 1, 5 and 8

• Clinical dosimetry based on tissue radiation effective dose calculated from PET image acquisition data

  On days 1, 5 and 8

• Concentration of 89Zr-DFO-REGN5054 in serum

  On days 1, 5 and 8

• Serum imaging agent activity concentration of area under the curve (AUC0-7)

  Up to day 8

• 89Zr-DFO-REGN5054 uptake across cluster of differentiation 8 (CD8)-expressing normal tissues and tumors

  At the time of imaging, up to day 8

Study Arms (2)

Single ascending dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab

EXPERIMENTAL

Part A: Doses of 89Zr˗DFO˗REGN5054 may be reduced based upon assessment.

Drug: 89Zr˗DFO˗REGN5054; Drug: cemiplimab

Defined dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab

EXPERIMENTAL

Part B: Defined dose of 89Zr˗DFO˗REGN5054 determined in Part A.

Drug: 89Zr˗DFO˗REGN5054; Drug: cemiplimab

Interventions

89Zr˗DFO˗REGN5054 DRUG

Administered by intravenous (IV) infusion during Part A and B.

Defined dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab; Single ascending dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab

cemiplimab DRUG

Administered by IV infusion every 3 weeks (Q3W).

Also known as: REGN2810, Libtayo

Defined dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab; Single ascending dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

UMC Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 28, 2022
• Study Start: February 7, 2023
• Primary Completion (Estimated): January 6, 2027
• Study Completion (Estimated): January 6, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

NL (1)