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Metastatic Solid TumorPhase 1/2NCT04706715

LAG3 PET Imaging in Advanced Solid Tumors

A Phase 1/2 study testing 89Zr-DFO-REGN3767 and Cemiplimab in people with Metastatic Solid Tumor, run by University Medical Center Groningen at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an investigator-initiated, single-center, open-label clinical trial designed to evaluate the safety and PK of the PET tracer 89Zr-DFO-REGN3767 in patients prior to and during treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Solid Tumor
What is being tested?
89Zr-DFO-REGN3767 and Cemiplimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteNetherlands
Study dates
18 Jan 2022to Nov 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Age ≥ 18 years at the time of signing informed consent.
  • Patients with histologically confirmed diagnosis of locally advanced or metastatic solid cancer types who, according to the opinion of the investigator, based on available clinical data, may benefit from PD1 antibody with or without platinum-based chemotherapy.
  • At least 1 lesion that is accessible per investigator's assessment and eligible for biopsy according to standard clinical care procedures.
  • Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions except for lesions that have progressed after radiotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 12 weeks.
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  • Adequate organ and bone marrow function as defined below:
  • Hemoglobin ≥9.0 g/dL
  • Absolute neutrophil count ≥1.5 x 109/L
  • Absolute lymphocyte count ≥0.75 x 109/L
  • Platelet count ≥100 x 109/L
  • Serum creatinine ≤1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate > 30 mL/min/1.73 m2. A 24-hour urine creatinine collection may substitute for the calculated creatinine clearance to meet eligibility criteria.
  • Adequate hepatic function:
  • Total bilirubin ≤1.5 x ULN (≤3 x ULN if liver tumor involvement); Patients with Gilbert's syndrome do not need to meet total bilirubin requirements, provided their total bilirubin is unchanged from their baseline. Gilbert's syndrome must be documented appropriately as past medical history.
  • Aspartate aminotransferase (AST) ≤2.5 x ULN (≤5 x ULN if liver tumor involvement) iii. Alanine aminotransferase (ALT) ≤2.5 x ULN (≤5 x ULN if liver tumor involvement) iv. Alkaline phosphatase (ALP) ≤2.5 x ULN (≤5 x ULN if liver or bone tumor involvement)
  • Signed informed consent.
  • Willingness and ability to comply with all protocol required procedures.

Who cannot join

  • Treatment with any approved anti-cancer therapy, investigational agent, or participation in another clinical trial with therapeutic intent within 28 days prior to 89Zr-DFO-REGN3767 injection.
  • Prior ICI treatment, including but not limited to anti-PD1 and anti-PD-L1 therapeutic antibodies.
  • Encephalitis, meningitis or uncontrolled seizures in the year prior to inclusion.
  • Any unresolved toxicity (>CTCAE grade 2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
  • Symptomatic, untreated brain metastasis, leptomeningeal disease, or spinal cord compression. Patients are eligible if central nervous system (CNS) metastases are adequately treated and neurologically stable for at least 2 weeks prior to enrollment.
  • Documented allergic or acute hypersensitivity reaction attributed to antibody treatments.
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  • Major surgical procedure other than for diagnosis within 28 days prior to 89Zr-DFO-REGN3767 injection or anticipation of need for a major surgical procedure during the course of the study.
  • For patients that will be treated with cemiplimab in combination with platinum containing chemotherapy, the following additional criteria apply:
  • Age > 70 years
  • Leucopenia <3 x 109/L
  • Estimated glomerular filtration rate < 60 mL/min/1.73 m2
  • Cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), unstable angina, unstable cardiac arrhythmias, myocardial infarction < 3 months ago, or cerebrovascular accident < 6 months ago.
  • Hearing loss
  • Any other exclusion criteria, according to the local clinical practice guidelines for the chosen chemotherapy regimen.
  • History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematous, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis.
  • Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for his study.
  • Patients with controlled type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 4 weeks prior to 89Zr-DFO-REGN3767 injection.
  • Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g. a one-time of dexamethasone for nausea) may be enrolled in the study after discussion with and approval by the sponsor.
  • The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g. fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
  • Prior allogeneic bone marrow transplantation or solid organ transplant.
  • Active infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C or tuberculosis infection; or diagnosis of immunodeficiency
  • Patients will be tested for hepatitis C virus (HCV) and hepatitis B virus (HBV) at screening.
  • Patients with known HIV infection who have controlled infection (undetectable viral load (HIV ribonucleic acid (RNA) polymerase chain reaction (PCR)) and CD4 count above 350 either spontaneously or on a stable antiviral regimen are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.
  • Patients with hepatitis B who have a controlled infection (serum HBV deoxyribonucleic acid (DNA) PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.
  • Patients who are HCV antibody positive who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.
  • Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
  • Active infection, that requires systemic antibiotics within 2 weeks prior to 89Zr-DFO-REGN3767 injection.
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of 89Zr-DFO-REGN3767, or that may affect the interpretation of the results or render the patient at high risk from complications.
  • Receipt of a live vaccine (including attenuated) within 30 days of planned start of study medication.
  • Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  • Sponsor employee/member of the clinical site study team and/or his or her immediate family
  • Women with a positive serum chorionic gonadotropin HCG pregnancy test at the screening/baseline visit. Breastfeeding women are also excluded.
  • Women of childbearing potential* and sexually active men who are unwilling to practice highly effective contraception prior to the first dose of study therapy, during the study, and for at least 6 months after the last dose.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Groninen

    Groningen, 9713 GZ

Other trials in Netherlands

About this study

Official title: ImmunoPET Imaging With 89Zr-DFO-REGN3767 in Patients With Advanced Solid Cancer Prior to and During Treatment With Cemiplimab With or Without Platinum-based Chemotherapy

This is an investigator-initiated, single-center, open-label clinical trial designed to evaluate the safety and PK of the PET tracer 89Zr-DFO-REGN3767 in patients prior to and during treatment.

Being tested
89Zr-DFO-REGN3767, Cemiplimab
Keywords
cancer, immune checkpoint inhibitor, positron emission tomography, LAG-3
Medical subject headings
Neoplasm Metastasis, Neoplasms

What participants receive

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

  • 89Zr-DFO-REGN3767Other

    Anti-LAG-3 PET imaging tracer

  • CemiplimabDrug

    Cemiplimab 350 mg every 3 weeks with or without platinum-based chemotherapy.

Study groups in NCT04706715
Study groupRoleWhat they receive
Dose finding cohortExperimentalIn part A of this imaging trial, a dose finding study will be performed to establish safety, to assess the appropriate protein dose for PET-scanning and to assess the appropriate PET scanning interval. After completion of imaging, patients will start treatment with cemiplimab with or without platinum-based chemotherapy.
Receives: Other: 89Zr-DFO-REGN3767; Drug: Cemiplimab
Feasibility cohortExperimentalThe purpose of part B of the study is to analyze the PK of 89Zr-DFO-REGN3767 in patients before and during treatment with cemiplimab with or without platinum-based chemotherapy.
Receives: Other: 89Zr-DFO-REGN3767; Drug: Cemiplimab

What is being measured

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

  1. Optimal 89Zr-DFO-REGN3767 dose and PET imaging timepoint

    Determine the optimal 89Zr-DFO-REGN3767 dose and optimal PET imaging timepoint.

    Measured: 2 years

  2. Pharmacokinetics (PK) of 89Zr-DFO-REGN3767

    Description of PK of 89Zr-DFO-REGN3767 by measuring standardized uptake value (SUV) on PET scans performed 0, 2, 4 and/or 7 days after tracer injection.

    Measured: 2 years

  3. Incidence of adverse events related to 89Zr-DFO-REGN3767 administration as assessed by CTCAE v5.0

    Safety assessment through summaries of adverse events, changes in laboratory test results (if evaluation is indicated) and changes in vital signs. Adverse event data will be recorded and summarized according to NCI CTCAE v5.0

    Measured: 2 years

Secondary outcomes (4)

  1. Heterogeneity of 89Zr-DFO-REGN3767 antibody tumor uptake

    Heterogeneity of 89Zr-DFO-REGN3767 uptake will be evaluated by measuring standardized uptake value (SUV) in defined volumes of interest (VOIs) of tumor lesions on the PET scan images.

    Measured: 2 years

  2. Correlation of tumor tracer uptake with tumor and immune cell LAG3 expression

    Results of immunohistochemical (IHC) scoring of immune cell LAG3 expression will be described as a semi-quantitative score using the percentage of positive cells (continuous variable), intensity and pattern of staining (discrete variable). These IHC results will be compared with imaging tracer standardized uptake value (SUV) in defined volumes of interest (VOIs) of tumor lesions on the PET scan images.

    Measured: 2 years

  3. Correlation of tumor tracer uptake with response to cemiplimab

    Response to therapy with cemiplimab (with or without chemotherapy) will be assessed according to the RECIST or iRECIST guidelines. These results will be compared with imaging tracer standardized uptake value (SUV) in defined volumes of interest (VOIs) of tumor lesions on the PET scan images.

    Measured: 2 years

  4. Assessment of changes in tumor and normal organ uptake

    Patients enrolled in part B will undergo a PET scan at baseline and another one after 2 treatment cycles. 89Zr-DFO-REGN3767 tracer uptake will be quantified and expressed as standardized uptake value (SUV) in defined volumes of interest (VOIs) for both scans. The results of both PET scans will be compared to assess changes in imaging tracer uptake over time.

    Measured: 2 years

Timeline

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

  1. First posted13 Jan 2021
  2. Study start18 Jan 2022
  3. Primary completionNov 2025 (estimated)
  4. Study completionNov 2025 (estimated)

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 1/2
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04706715
Sponsor's protocol ID
202000570
Status last verified
May 2025
First submitted
3 Dec 2020
Last updated
31 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 89Zr-DFO-REGN3767 and Cemiplimab in people with Metastatic Solid Tumor, run by University Medical Center Groningen at 1 site in Netherlands.

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 17 inclusion and 36 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: under way, not looking for participants, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Optimal 89Zr-DFO-REGN3767 dose and PET imaging timepoint (time frame: 2 years). The study lists 3 primary outcomes in all. 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 NCT04706715.

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 31 May 2025.

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