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Study of ImmunoPet Imaging of PD-L1 in Tumors Using 89Zr-DFO-REGN3504 in Participants With Advanced PD-L1 Positive Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03746704
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The primary objective of the study is to determine the safety and tolerability of 89Zr-DFO-REGN3504.

The secondary objectives of the study are:

Study Part A only:

  • To establish adequate mass dose and activity dose of 89Zr˗DFO˗REGN3504 and optimal post-infusion imaging time, as assessed by imaging and blood draw after tracer infusion

Study Part B only:

  • To establish test/re-test reliability of positron emission tomography (PET) measures as assessed on 2 separate tracer infusions at adequate mass dose and optimal imaging time point as determined in Part A
  • To characterize the pharmacokinetic (PK) profile of 89Zr˗DFO˗REGN3504 based on tracer plasma activity concentration

Condition or disease Intervention/treatment Phase
Advanced PD-L1 Positive Malignancies Hepatocellular Carcinoma Gastroesophageal Junction Adenocarcinoma Gastric Cancer Drug: 89Zr˗DFO˗REGN3504 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, First-in-Human Study of ImmunoPET Imaging of PD-L1 in Tumors Using 89Zr-DFO-REGN3504, an Anti-PD-L1 Tracer for Positron Emission Tomography in Patients With Advanced PD-L1 Positive Malignancies
Actual Study Start Date : September 4, 2019
Estimated Primary Completion Date : October 14, 2022
Estimated Study Completion Date : November 4, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part A: Cohort 1
Part A: Cohort 1 will receive a single IV dose of 89Zr˗DFO˗REGN3504
Drug: 89Zr˗DFO˗REGN3504
89Zr˗DFO˗REGN3504

Experimental: Part A: Cohort 2
Part A: Cohort 2 will receive a single IV dose of 89Zr˗DFO˗REGN3504. Doses in Part A are sequentially ascending.
Drug: 89Zr˗DFO˗REGN3504
89Zr˗DFO˗REGN3504

Experimental: Part A: Cohort 3
Part A: Cohort 3 will receive a single IV dose of 89Zr˗DFO˗REGN3504. Doses in Part A are sequentially ascending.
Drug: 89Zr˗DFO˗REGN3504
89Zr˗DFO˗REGN3504

Experimental: Part B
Part B will receive IV doses of 89Zr˗DFO˗REGN3504
Drug: 89Zr˗DFO˗REGN3504
89Zr˗DFO˗REGN3504




Primary Outcome Measures :
  1. Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline through 90 days after last dose of tracer infusion ]

Secondary Outcome Measures :
  1. Standardized uptake value (SUV) of 89Zr˗DFO˗REGN3504 in the blood pool [ Time Frame: Up to day 8 ]
    Part A

  2. Clinical dosimetry based on the equivalent dose of radiation [ Time Frame: Up to day 8 ]
    Part A

  3. Clinical dosimetry based on the effective dose of radiation [ Time Frame: Up to day 8 ]
    Part A

  4. SUVs across the tumor region of interest (ROIs) [ Time Frame: Up to day 8 ]
    Part A

  5. Maximal SUVs (SUVmax) within tumor ROIs [ Time Frame: Up to day 8 ]
    Part A

  6. Pharmacokinetics (PK) of 89Zr˗DFO˗REGN3504; plasma tracer activity concentration of area under the curve (AUC0-7) [ Time Frame: Up to day 8 ]
    Part A

  7. Change in SUV of 89Zr˗DFO˗REGN3504 in the blood pool [ Time Frame: Up to day 36 ± 14 days ]
    Part B

  8. Change in SUVs across the tumor ROIs [ Time Frame: Up to day 36 ± 14 days ]
    Part B

  9. Change in SUVmax within the tumor ROIs [ Time Frame: Up to day 36 ± 14 days ]
    Part B

  10. Biodistribution of 89Zr˗DFO˗REGN3504 [ Time Frame: Up to day 36 ± 14 days ]
    Part B



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Participants with at least 1 radiologically measurable (by RECIST 1.1) lesion (Note: Lesions 10 mm in diameter or larger at the high end PD-L1 expression are expected to be detectable by 89Zr-DFO-REGN3504 PET imaging).
  • Availability of an archival, formalin-fixed, paraffin-embedded tumor tissue sample from a primary/metastatic/recurrent site, which has not been previously irradiated, with presence of any PD-L1 expression by IHC in tumor or immune cells
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 (Oken, 1982) and anticipated life expectancy of at least 3 months
  • Adequate organ and bone marrow function

Key Exclusion Criteria:

  • Participants receiving therapy with a monoclonal antibody against PD-L1 (eg. durvalumab, atezolizumab, avelumab) or have received treatment with anti-PD-L1 within 135 days prior to the 89Zr˗DFO˗REGN3504 infusion date
  • For Part B only, participants in whom anti-PD-1 therapy was initiated 1 month or less, prior to the 89Zr˗DFO˗REGN3504 infusion date
  • Active or untreated brain metastases or spinal cord compression. Participants are eligible if the central nervous system (CNS) metastases are adequately treated and participants' neurological symptoms have returned to baseline levels (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. Participants with brain metastases must be off doses of corticosteroid therapy that are considered by the investigator to be immunosuppressive
  • Known history of human immunodeficiency virus or known acquired immunodeficiency syndrome indicating uncontrolled active infection. Participants on highly active antiretroviral therapy with undetectable RNA levels and CD4 counts above 350 are permitted
  • Receipt of an investigational compound or device within 30 days of screening or within 5 half-lives of the investigational compound or therapy being studied (whichever is greater)
  • Major surgery or significant traumatic injury within 4 weeks prior to first dose of 89Zr˗DFO˗REGN3504
  • Known psychiatric or substance abuse disorder, including current use of any illicit drugs, that would interfere with the participant's participation in, or compliance with the requirements of, the study
  • Sexually active men and women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose.
  • Part B only: Has been enrolled in Part A

Note: Other Protocol Inclusion/Exclusion Criteria apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746704


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, New York
Regeneron Study Site Recruiting
New York, New York, United States, 10029
Regeneron Study Site Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03746704    
Other Study ID Numbers: R3504-ONC-1701
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual patient data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data 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, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases