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89Zr-DFO-REGN3767 in PET Scans in People With Diffuse Large B Cell Lymphoma (DLBCL)

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: NCT04566978
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

The main purposes of this study include:

Looking at the way the body absorbs, distributes, and gets rid of 89Zr-DFO-REGN3767

Finding the best dose amount of 89Zr-DFO-REGN3767

Finding the best time for PET scanning after injection of 89Zr-DFO-REGN3767


Condition or disease Intervention/treatment Phase
Large B-cell Lymphoma DLBCL Drug: 89Zr-DFO-REGN3767 Diagnostic Test: PET/CT Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of 89Zr-DFO-REGN3767 Anti LAG-3 Antibody Positron Emission Tomography in Patients With Relapsed/Refractory DLBCL
Actual Study Start Date : September 11, 2020
Estimated Primary Completion Date : September 11, 2022
Estimated Study Completion Date : September 11, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Cohort 1
Up to 3 participants will be enrolled to receive a single dose of 89Zr-DFO-REGN3767 (total 2mg antibody mass). Participant to undergo 3 PET/CT scans and concurrent blood draws for PK
Drug: 89Zr-DFO-REGN3767
89Zr-DFO-REGN3767 is comprised of the anti-LAG-3 antibody, REGN3767 labeled with the positron-emitter zirconium-89 (89Zr) through the chelator-linker DFO. REGN3767 is an investigational monoclonal antibody that target LAG-3 receptors.

Diagnostic Test: PET/CT

A PET/CT scan extending from top of skull to feet will be performed to determine the biodistribution.

Part A patients will be imaged at three time points post-injection to allow for selection of optimal imaging time and dosimetry determination. For these patients, top of skull to feet scans will be acquired:

  • Within one to four hours following injection of tracer on Day 1
  • 24-72 hours post-injection (Day 2-4)
  • 20-168 hours post-injection (once during days 5-7)

Experimental: Cohort 2
Up to 3 participants will be enrolled to receive a total 5mg of 89Zr-DFO-REGN3767 (+REGN3767) total antibody mass for PK and serial imaging with 3 PET/CT scans
Drug: 89Zr-DFO-REGN3767
89Zr-DFO-REGN3767 is comprised of the anti-LAG-3 antibody, REGN3767 labeled with the positron-emitter zirconium-89 (89Zr) through the chelator-linker DFO. REGN3767 is an investigational monoclonal antibody that target LAG-3 receptors.

Diagnostic Test: PET/CT

A PET/CT scan extending from top of skull to feet will be performed to determine the biodistribution.

Part A patients will be imaged at three time points post-injection to allow for selection of optimal imaging time and dosimetry determination. For these patients, top of skull to feet scans will be acquired:

  • Within one to four hours following injection of tracer on Day 1
  • 24-72 hours post-injection (Day 2-4)
  • 20-168 hours post-injection (once during days 5-7)

Experimental: Cohort 3
Up to 3 participants will be enrolled to receive a total 10mg of 89Zr-DFO-REGN3767 (+REGN3767) total antibody mass for PK and serial imaging with 3 PET/CT scans
Drug: 89Zr-DFO-REGN3767
89Zr-DFO-REGN3767 is comprised of the anti-LAG-3 antibody, REGN3767 labeled with the positron-emitter zirconium-89 (89Zr) through the chelator-linker DFO. REGN3767 is an investigational monoclonal antibody that target LAG-3 receptors.

Diagnostic Test: PET/CT

A PET/CT scan extending from top of skull to feet will be performed to determine the biodistribution.

Part A patients will be imaged at three time points post-injection to allow for selection of optimal imaging time and dosimetry determination. For these patients, top of skull to feet scans will be acquired:

  • Within one to four hours following injection of tracer on Day 1
  • 24-72 hours post-injection (Day 2-4)
  • 20-168 hours post-injection (once during days 5-7)

Experimental: Cohort 4
Up to 3 participants will be enrolled to receive a total 20mg of 89Zr-DFO-REGN3767 (+REGN3767) total antibody mass for PK and serial imaging with 3 PET/CT scans
Drug: 89Zr-DFO-REGN3767
89Zr-DFO-REGN3767 is comprised of the anti-LAG-3 antibody, REGN3767 labeled with the positron-emitter zirconium-89 (89Zr) through the chelator-linker DFO. REGN3767 is an investigational monoclonal antibody that target LAG-3 receptors.

Diagnostic Test: PET/CT

A PET/CT scan extending from top of skull to feet will be performed to determine the biodistribution.

Part A patients will be imaged at three time points post-injection to allow for selection of optimal imaging time and dosimetry determination. For these patients, top of skull to feet scans will be acquired:

  • Within one to four hours following injection of tracer on Day 1
  • 24-72 hours post-injection (Day 2-4)
  • 20-168 hours post-injection (once during days 5-7)




Primary Outcome Measures :
  1. Biodistribution of 89Zr-DFO-REGN3767 [ Time Frame: 2 years ]
    A PET/CT scan extending from top of skull to feet will be performed to determine the biodistribution of 89Zr-DFO-REGN3767

  2. Optimal 89Zr-DFO-REGN3767 mass dose for tumor targeting [ Time Frame: 2 years ]
    Determine the optimal 89Zr-DFO-REGN3767 mass dose for tumor targeting

  3. Optimal time for imaging and tumor uptake post 89Zr-DFO-REGN3767 administration [ Time Frame: 2 years ]
    Determine the optimal time for imaging and tumor uptake post 89Zr-DFO-REGN3767 administration

  4. Tumor lesion uptake of 89Zr-DFO-REGN3767 and correlate with LAG-3 expression by IHC [ Time Frame: 2 years ]
    Evaluate tumor lesion uptake of 89Zr-DFO-REGN3767 and correlate with LAG-3 expression by IHC in tumors will be compared descriptively with other biomarkers of tumor immune environment characterized in biopsies, such as quantitation of IHC score (LAG-3 and / or other immune cell markers), or other biomarker measures.



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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

Inclusion Criteria:

A patient must be eligible for DLBCL expansion cohort 9 in study 17-421 and, in addition, meet the following criteria to be eligible for inclusion in the study:

  • Measurable disease by Lugano criteria, with at least one lesion outside of the liver
  • Patients must have eGFR >50 mL/min/1.73m2.

Exclusion Criteria:

A patient must be eligible for DLBCL expansion cohort 9 in study 17-421 and, in addition, a patient who meets any of the following criteria will be excluded from the study:

  • Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug-related toxicity.
  • Has not yet recovered (i.e. ≤ Grade 1 or baseline) from any acute toxicities from prior anticancer therapy except for laboratory changes as described in inclusion criteria in study 17-421, except as noted. NOTE: Patients with chronic or stable toxicity following approved therapy, such as mild persistent neuropathy, are allowed.
  • Has received radiation therapy within 14 days of first administration of study drug or has not recovered (i.e. ≤ Grade 1 or baseline) from adverse events, except for laboratory changes as described in inclusion criteria, except as noted. NOTE: Patients with chronic or stable toxicity, such as mild persistent neuropathy, are allowed.
  • Women who are pregnant, breastfeeding *Postmenopausal women must be amenorrhoeic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation. Pregnancy testing and screening will be performed per MSK and Department of Radiology standard pregnancy screening guidelines.

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): NCT04566978


Contacts
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Contact: Neeta Pandi-Taskar, MD 212-639-3046 pandit-n@mskcc.org
Contact: Lia Palomba, MD 646-608-3711 palombam@mskcc.org

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Neeta Pandit-Taskar, MD    212-639-3046      
Contact: Lia E. Lalomba, MD    646-608-3711      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Neeta Pandi-Taskar, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04566978    
Other Study ID Numbers: 19-479
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Large B-cell Lymphoma
DLBCL
Memorial Sloan Kettering Cancer Center
19-479
89Zr-DFO-REGN3767
anti LAG-3 antibody
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin