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Advanced PD-L1 Positive MalignanciesPhase 1NCT03746704

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 study testing 89Zr˗DFO˗REGN3504 in people with Advanced PD-L1 Positive Malignancies, run by Regeneron Pharmaceuticals at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced PD-L1 Positive Malignancies
What is being tested?
89Zr˗DFO˗REGN3504
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
2 sitesUnited States
Study dates
4 Sep 2019to 8 Jul 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with at least 1 radiologically measurable (by RECIST 1.1) lesion (Note: Lesions 10 mm in diameter or larger at the high end Program Dealth-Ligand 1 (PD-L1) expression are expected to be detectable by 89Zr-DFO-REGN3504 PET imaging).
  • Availability of an archival, formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample (blocks or slides) from a primary/metastatic/recurrent site, which has not been previously irradiated, with presence of any PD-L1 expression by Immunohistochemistry (IHC) in tumor or immune cells, performed by a Clinical Laboratory Improvement Amendments of 1988 (CLIA), a certified laboratory, using either freshly cut or archived FFPE slides. If the analysis will be done using archived FFPE slides, the slides must be <6 months old after being cut from the tissue block. The age of a tissue block is not limited. If the patient has a report of ≥1% PD-L1 expression, there is no need to repeat the assay; the report has no time limit.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 (Oken, 1982) and anticipated life expectancy of at least 3 months
  • Adequate organ and bone marrow function

Who cannot join

  • Participants receiving therapy with a monoclonal antibody against PD-L1 (eg. durvalumab, atezolizumab, avelumab) or have received treatment with anti-PD-L1 within 135 days prior to the 89Zr˗DFO˗REGN3504 infusion date
  • For Part B only, participants in whom anti-PD-1 therapy was initiated 1 month or less, prior to the 89Zr˗DFO˗REGN3504 infusion date
  • Active or untreated brain metastases or spinal cord compression. Participants are eligible if the central nervous system (CNS) metastases are adequately treated and participants' neurological symptoms have returned to baseline levels (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. Participants with brain metastases must be off doses of corticosteroid therapy that are considered by the investigator to be immunosuppressive
  • Known history of human immunodeficiency virus or known acquired immunodeficiency syndrome indicating uncontrolled active infection. Participants on highly active antiretroviral therapy with undetectable RNA levels and CD4 counts above 350 are permitted
  • Receipt of an investigational compound or device within 30 days of screening or within 5 half-lives of the investigational compound or therapy being studied (whichever is greater)
  • Major surgery or significant traumatic injury within 4 weeks prior to first dose of 89Zr˗DFO˗REGN3504
Show all 11Show fewer
  • Known psychiatric or substance abuse disorder, including current use of any illicit drugs, that would interfere with the participant's participation in, or compliance with the requirements of, the study
  • History of hypersensitivity response to any protein therapeutics (eg, recombinant proteins, vaccines, IV immune globulins, monoclonal antibodies, receptor traps). If a patient intends to receive a COVID-19 vaccine during Part A only, participation in the dose-escalation part of the study should be delayed at least 1 week after the final dose of COVID-19 vaccine before the start of study drug.
  • Sexually active men and women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose.
  • Part B only: Has been enrolled in Part A
  • Note: Other Protocol Inclusion/Exclusion Criteria apply

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Regeneron Study Site

    New York, New York, 10029

  • Regeneron Study Site

    New York, New York, 10032

Other trials in United States

About this study

Official title: 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

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
Being tested
89Zr˗DFO˗REGN3504

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 89Zr˗DFO˗REGN3504Drug

    89Zr˗DFO˗REGN3504

Study groups in NCT03746704
Study groupRoleWhat they receive
89Zr˗DFO˗REGN3504ExperimentalPart A: Cohorts 1-3 Part B
Receives: Drug: 89Zr˗DFO˗REGN3504

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of treatment-emergent adverse events (TEAEs)

    Measured: Baseline through 90 days after last dose of tracer infusion

Secondary outcomes (10)

  1. Standardized uptake value (SUV) of 89Zr˗DFO˗REGN3504 in the blood pool

    Part A

    Measured: Up to day 8

  2. Clinical dosimetry based on the equivalent dose of radiation

    Part A

    Measured: Up to day 8

  3. Clinical dosimetry based on the effective dose of radiation

    Part A

    Measured: Up to day 8

  4. SUVs across the tumor region of interest (ROIs)

    Part A

    Measured: Up to day 8

  5. Maximal SUVs (SUVmax) within tumor ROIs

    Part A

    Measured: Up to day 8

  6. Pharmacokinetics (PK) of 89Zr˗DFO˗REGN3504; plasma tracer activity concentration of area under the curve (AUC0-7)

    Part A

    Measured: Up to day 8

  7. Change in SUV of 89Zr˗DFO˗REGN3504 in the blood pool

    Part B

    Measured: Up to day 36 ± 14 days

  8. Change in SUVs across the tumor ROIs

    Part B

    Measured: Up to day 36 ± 14 days

  9. Change in SUVmax within the tumor ROIs

    Part B

    Measured: Up to day 36 ± 14 days

  10. Biodistribution of 89Zr˗DFO˗REGN3504

    Part B

    Measured: Up to day 36 ± 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2018
  2. Study start4 Sep 2019
  3. Primary completion8 Jul 2021
  4. Study completion8 Jul 2021

Why it stopped: Business decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03746704
Sponsor's protocol ID
R3504-ONC-1701
Status last verified
Feb 2022
First submitted
15 Nov 2018
Last updated
23 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All individual patient data (IPD) that underlie publicly available results will be considered for sharing

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 89Zr˗DFO˗REGN3504 in people with Advanced PD-L1 Positive Malignancies, run by Regeneron Pharmaceuticals at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: Baseline through 90 days after last dose of tracer infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03746704.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.

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