89Zr-DFO-REGN3767 in PET Scans in People With Diffuse Large B Cell Lymphoma (DLBCL)
NCT ID: NCT04566978
Last Updated: 2025-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
7 participants
INTERVENTIONAL
2020-09-11
2025-03-21
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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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
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.
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)
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
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.
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)
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
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.
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)
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
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.
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)
Interventions
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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.
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)
Eligibility Criteria
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Inclusion Criteria
* Measurable disease by Lugano criteria, with at least one lesion outside of the liver
* Patients must have eGFR \>50 mL/min/1.73m2.
* 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.
Exclusion Criteria
* Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug-related toxicity.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Neeta Pandi-Taskar, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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19-479
Identifier Type: -
Identifier Source: org_study_id
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