89Zr-DFO-REGN3767 in PET Scans in People With Diffuse Large B Cell Lymphoma (DLBCL)
A Pilot Study of 89Zr-DFO-REGN3767 Anti LAG-3 Antibody Positron Emission Tomography in Patients With Relapsed/Refractory DLBCL
1 other identifier
interventional
7
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Sep 2020
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 11, 2020
CompletedFirst Submitted
Initial submission to the registry
September 15, 2020
CompletedFirst Posted
Study publicly available on registry
September 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2025
CompletedApril 23, 2025
April 1, 2025
4.5 years
September 15, 2020
April 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Biodistribution of 89Zr-DFO-REGN3767
A PET/CT scan extending from top of skull to feet will be performed to determine the biodistribution of 89Zr-DFO-REGN3767
2 years
Optimal 89Zr-DFO-REGN3767 mass dose for tumor targeting
Determine the optimal 89Zr-DFO-REGN3767 mass dose for tumor targeting
2 years
Optimal time for imaging and tumor uptake post 89Zr-DFO-REGN3767 administration
Determine the optimal time for imaging and tumor uptake post 89Zr-DFO-REGN3767 administration
2 years
Tumor lesion uptake of 89Zr-DFO-REGN3767 and correlate with LAG-3 expression by IHC
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.
2 years
Study Arms (4)
Cohort 1
EXPERIMENTALUp 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
Cohort 2
EXPERIMENTALUp 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
Cohort 3
EXPERIMENTALUp 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
Cohort 4
EXPERIMENTALUp 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
Interventions
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.
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
You may qualify if:
- Measurable disease by Lugano criteria, with at least one lesion outside of the liver
- Patients must have eGFR \>50 mL/min/1.73m2.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neeta Pandi-Taskar, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2020
First Posted
September 28, 2020
Study Start
September 11, 2020
Primary Completion
March 21, 2025
Study Completion
March 21, 2025
Last Updated
April 23, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
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.