NCT03746704

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced PD-L1 Positive Malignancies

Interventions

Type	Name	Description
DRUG	89Zr˗DFO˗REGN3504	89Zr˗DFO˗REGN3504

Timeline

• Start date: 2019-09-04
• Primary completion: 2021-07-08
• Completion: 2021-07-08
• First posted: 2018-11-20
• Last updated: 2022-02-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study