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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05259709
Collaborator
(none)
44
Enrollment
2
Arms
44.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The primary objective of the study is to determine the safety and tolerability of 89Zr-DFO-REGN5054 alone and in combination with cemiplimab.

The secondary objectives include:
For Part A:

  • To characterize the radioactivity pharmacokinetic (PK) profile of 89Zr-DFO-REGN5054

  • To establish an adequate mass dose and activity dose of 89Zr-DFO-REGN5054 and optimal post-infusion time for imaging

For Parts A and B:

  • To evaluate the association of CD8 expression in tissue biopsies [via immunohistochemistry (IHC)] with tumor 89Zr˗DFO˗REGN5054 uptake in vivo [via positron emission tomography (PET)] and ex vivo (via autoradiography)

  • To evaluate the uptake of 89Zr˗DFO˗REGN5054 in tumors, normal CD8-expressing tissues, and blood

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A First-in-Human Study of 89Zr-DFO-REGN5054 (Anti-CD8) Positron Emission Tomography in Patients With Solid Malignancies Treated With Cemiplimab
Anticipated Study Start Date :
Sep 9, 2022
Anticipated Primary Completion Date :
May 13, 2026
Anticipated Study Completion Date :
May 13, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single ascending dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab

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

Drug: 89Zr˗DFO˗REGN5054
Administered by intravenous (IV) infusion during Part A and B.

Drug: cemiplimab
Administered by IV infusion every 3 weeks (Q3W).
Other Names:
  • REGN2810
  • Libtayo

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

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

    Drug: 89Zr˗DFO˗REGN5054
    Administered by intravenous (IV) infusion during Part A and B.

    Drug: cemiplimab
    Administered by IV infusion every 3 weeks (Q3W).
    Other Names:
  • REGN2810
  • Libtayo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence and severity of treatment-emergent adverse events (TEAEs) [Up to day 8, after the infusion of 89Zr˗DFO˗REGN5054]

      Part A

    2. Incidence and severity of TEAEs [Up to approximately week 115]

      Part A and B

    Secondary Outcome Measures

    1. 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.

    2. 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.

    3. Concentration of 89Zr-DFO-REGN5054 in serum [On days 1, 5 and 8]

      Part A

    4. Plasma imaging agent activity concentration of area under the curve (AUC0-7) [Up to day 8]

      Part A

    5. 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

    6. 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

    7. Association of 89Zr˗DFO˗REGN5054 autoradiographic signal intensity distribution with CD8 expression in tumor tissues [At Baseline]

      Part A and Part B

    8. Association of 89Zr-DFO-REGN5054 uptake with CD8 expression in tumor tissues [At Baseline]

      Part B

    9. Association of tumor-to-blood ratio of 89Zr-DFO-REGN5054 with CD8 expression in tumor tissues [At Baseline]

      Part B

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Advanced or metastatic solid tumors that may respond to anti-programmed cell death protein 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trials Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05259709
    Other Study ID Numbers:
    • R5054-ONC-1843
    • 2019-001604-38
    First Posted:
    Feb 28, 2022
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Regeneron Pharmaceuticals
    Positron Emission Tomography (PET) scan
    Immuno-PET
    Additional relevant MeSH terms:
    Neoplasms
    Cemiplimab

    Study Results

    No Results Posted as of Aug 8, 2022