drugset / Trial / NCT03746704

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

NCT03746704 ↗

Phase 1 Terminated 2 enrolled Regeneron Pharmaceuticals
NaSequentialOpen-labelBasic science

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

Timeline

Start
2019-09-04
Primary completion
2021-07-08
Completion
2021-07-08

Outcome

Outcome not reported

Stopped (Business): “Business decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject 89Zr˗DFO˗REGN3504 Diagnostic / imaging agent — —

Indications