NCT03746704

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

Terminated Phase 1 Last updated 23 February 2022

What this trial tests

Phase 1 trial testing 89Zr˗DFO˗REGN3504 in Advanced PD-L1 Positive Malignancies in 2 participants. Terminated before completion.

Timeline

4 September 2019

Primary endpoint
8 July 2021

8 July 2021

Quick facts

Lead sponsor	Regeneron Pharmaceuticals
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	basic science
Enrollment	2
Start date	4 September 2019
Primary completion	8 July 2021
Estimated completion	8 July 2021
Sites	2 locations across United States

Drugs / interventions tested

• 89Zr˗DFO˗REGN3504 — full drug profile →

Conditions studied

• Advanced PD-L1 Positive Malignancies — all drugs for Advanced PD-L1 Positive Malignancies →

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Advanced PD-L1 Positive Malignancies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. ImmunoPET: Concept, Design, and Applications.
   Wei W, Rosenkrans ZT, Liu J, Huang G, et al · · 2020 · cited 329× · PMID 32202104 · DOI 10.1021/acs.chemrev.9b00738
2. Radiolabeled Antibodies for Cancer Imaging and Therapy.
   Parakh S, Lee ST, Gan HK, Scott AM. · · 2022 · cited 78× · PMID 35326605 · DOI 10.3390/cancers14061454
3. Molecular imaging biomarkers for immune checkpoint inhibitor therapy.
   van de Donk PP, Kist de Ruijter L, Lub-de Hooge MN, Brouwers AH, et al · · 2020 · cited 74× · PMID 32042331 · DOI 10.7150/thno.38339
4. Preclinical PET imaging with the novel human antibody ⁸⁹Zr-DFO-REGN3504 sensitively detects PD-L1 expression in tumors and normal tissues.
   Kelly MP, Makonnen S, Hickey C, Arnold TC, et al · · 2021 · cited 23× · PMID 33483343 · DOI 10.1136/jitc-2020-002025
5. Imaging cellular immunotherapies and immune cell biomarkers: from preclinical studies to patients.
   Volpe A, Adusumilli PS, Schöder H, Ponomarev V. · · 2022 · cited 19× · PMID 36137649 · DOI 10.1136/jitc-2022-004902
6. Molecular imaging for cancer immunotherapy.
   Lim EA, Drake CG, Mintz A. · · 2020 · cited 11× · PMID 35756142 · DOI 10.1016/j.iotech.2020.03.001
7. Targeting the PD-1 Axis with Pembrolizumab for Recurrent or Metastatic Cancer of the Uterine Cervix: A Brief Update.
   Verhoeven Y, Quatannens D, Trinh XB, Wouters A, et al · · 2021 · cited 6× · PMID 33670397 · DOI 10.3390/ijms22041807
8. Positron Emission Tomography Probes for Imaging Cytotoxic Immune Cells.
   Amgheib A, Fu R, Aboagye EO. · · 2022 · cited 4× · PMID 36297474 · DOI 10.3390/pharmaceutics14102040