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

Primary Purpose

Large B-cell Lymphoma, DLBCL

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
89Zr-DFO-REGN3767
PET/CT
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Large B-cell Lymphoma focused on measuring Large B-cell Lymphoma, DLBCL, Memorial Sloan Kettering Cancer Center, 19-479, 89Zr-DFO-REGN3767, anti LAG-3 antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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
Optimal 89Zr-DFO-REGN3767 mass dose for tumor targeting
Determine the optimal 89Zr-DFO-REGN3767 mass dose for tumor targeting
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
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.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2020
Last Updated
October 16, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04566978
Brief Title
89Zr-DFO-REGN3767 in PET Scans in People With Diffuse Large B Cell Lymphoma (DLBCL)
Official Title
A Pilot Study of 89Zr-DFO-REGN3767 Anti LAG-3 Antibody Positron Emission Tomography in Patients With Relapsed/Refractory DLBCL
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
September 11, 2025 (Anticipated)
Study Completion Date
September 11, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Large B-cell Lymphoma, DLBCL
Keywords
Large B-cell Lymphoma, DLBCL, Memorial Sloan Kettering Cancer Center, 19-479, 89Zr-DFO-REGN3767, anti LAG-3 antibody

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
89Zr-DFO-REGN3767
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/CT
Intervention Description
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 Measure Information:
Title
Biodistribution of 89Zr-DFO-REGN3767
Description
A PET/CT scan extending from top of skull to feet will be performed to determine the biodistribution of 89Zr-DFO-REGN3767
Time Frame
2 years
Title
Optimal 89Zr-DFO-REGN3767 mass dose for tumor targeting
Description
Determine the optimal 89Zr-DFO-REGN3767 mass dose for tumor targeting
Time Frame
2 years
Title
Optimal time for imaging and tumor uptake post 89Zr-DFO-REGN3767 administration
Description
Determine the optimal time for imaging and tumor uptake post 89Zr-DFO-REGN3767 administration
Time Frame
2 years
Title
Tumor lesion uptake of 89Zr-DFO-REGN3767 and correlate with LAG-3 expression by IHC
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neeta Pandi-Taskar, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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

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