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Metastatic CancerPhase 1/2NCT04029181

ImmunoPET With an Anti-CD8 Imaging Agent

A Phase 1/2 study testing Anti-CD8 PET imaging agent in people with Metastatic Cancer and Unresectable Malignant Neoplasm, run by University Medical Center Groningen at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-center, single-arm, investigator sponsored trial designed to evaluate the PK of the anti-CD8 imaging agent in patients prior to and during treatment with checkpoint inhibitors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Anti-CD8 PET imaging agent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteNetherlands
Study dates
14 Feb 2019to Dec 2024
Phase
Phase 1/2
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

  • Subjects with histologically confirmed locally advanced or metastatic cancer for the following tumor types
  • Cancer types other than melanoma; subjects meeting the eligibility criteria as formulated in the MPDL3280A treatment study protocol (MPDL3280A-treatment-IST-UMCG) are eligible for part A or part B1.
  • Melanoma; subjects eligible to receive standard of care anti-PD1 therapy plus or minus ipilimumab, are eligible for part B2.
  • Tumor lesion(s) of which a histological biopsy can safely be obtained 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.
  • Signed informed consent.
Show all 11Show fewer
  • Age ≥18 at the time of signing informed consent.
  • Life expectancy ≥12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Ability to comply with the protocol.
  • For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly).

Who cannot join

  • Potential subjects with cancer other than melanoma will be excluded from participation in this study if they meet exclusion criteria formulated in the MPDL3280A treatment study protocol (MPDL3280A-treatment-IST-UMCG).
  • Signs or symptoms of infection within 2 weeks prior to anti-CD8 imaging agent injection.
  • Prior immune checkpoint inhibitor treatment, including but not limited to anti-PD1 and anti-PD-L1 therapeutic antibodies.
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • 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 the anti-CD8 imaging agent, or that may affect the interpretation of the results or render the patient at high risk from complications.
  • Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Groningen

    Groningen

Other trials in Netherlands

About this study

Official title: ImmunoPET Imaging With ZED88082A in Patients Before and During Treatment With 1) MPDL3280A or 2) PD-1 Antibody Plus or Minus Ipilimumab

This is a single-center, single-arm, investigator sponsored trial designed to evaluate the PK of the anti-CD8 imaging agent in patients prior to and during treatment with checkpoint inhibitors.

Being tested
Anti-CD8 PET imaging agent
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • Anti-CD8 PET imaging agentOther

    An imaging agent radiolabelled with 89Zr developed for in human PET imaging of CD8

Study groups in NCT04029181
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.
Receives: Other: Anti-CD8 PET imaging agent
Feasibility cohortExperimentalThe purpose of part B of the study is to analyze the PK of the anti-CD8 imaging agent in patients before and during treatment with checkpoint inhibitors.
Receives: Other: Anti-CD8 PET imaging agent

What is being measured

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

  1. Incidence of adverse events related to tracer administration as assessed by CTCAE v4.0

    Safety assessment through summaries of adverse events, changes in laboratory test results (if evaluation is indicated), changes in vital signs, and exposure to ZED88082A/CED88004S. Adverse event data will be recorded and summarized according to NCI CTCAE v4.0.

    Measured: 2 years

  2. Appropriate dosing of anti-CD8 imaging agent and PET imaging time points

    Appropriate dosing and imaging time points of the anti-CD8 imaging agent will be determined based on measurements of standardized uptake value (SUV) of defined volumes of interest (VOIs) on the immunoPET scan images

    Measured: 2 years

  3. Pharmacokinetics (PK) of anti-CD8 imaging agent

    Description of PK of the anti-CD8 imaging agent by measuring standardized uptake value (SUV) on PET scans performed 0, 2, 4 and/or 7 days after tracer injection before and during MPDL3280A or PD-1 antibody immune checkpoint inhibitor plus or minus ipilimumab treatment.

    Measured: 2 years

  4. Immunogenic potential of the anti-CD8 imaging agent by measuring incidence of anti-drug antibodies

    Assessment of the immunogenic potential of the anti-CD8 imaging agent by measuring incidence of anti-drug antibodies during the study relative to the prevalence of ADAs at baseline and assessing their relationship to other outcomes measured.

    Measured: 2 years

Secondary outcomes (5)

  1. Heterogeneity of tumor uptake of the anti-CD8 imaging agent

    Heterogeneity of imaging tracer uptake will be evaluated by measuring standardized uptake value (SUV) in defined volumes of interest (VOIs) of tumor lesions on the immunoPETscan images

    Measured: 2 years

  2. Correlation of normal organ uptake of the anti-CD8 imaging agent to (serious) adverse events (possibly) related to immune checkpoint inhibitor treatment

    Normal organ uptake of the anti-CD8 imaging agent as measured by SUVs on PET scan images will be analyzed on correlation to (serious) adverse events (possibly) related to ICI treatment, defined as all (S)AEs which are assessed as "possibly", "probably" or "definitely" related to ICI treatment.

    Measured: 2 years

  3. Correlation of tumor uptake of the anti-CD8 imaging agent and immune cell CD8 expression

    Results of immunohistochemical scoring of tumor and immune cell CD8 and other markers of lymphocytic infiltration in fresh biopsies 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 immunoPETscan images. Results of autoradiography will be described by measuring standardized uptake value (SUV) on the biopsy slides.

    Measured: 2 years

  4. Correlation of anti-CD8 imaging agent normal tissue kinetics with blood kinetics

    PK parameters will be derived from anti-CD8 imaging agent serum concentrations and will be summarized using descriptive statistics including but not limited to the number of patients, mean, standard deviation, median, minimum and maximum.

    Measured: 2 years

  5. Dosimetry

    Assessment of dosimetry will be performed by calculations of radioactivity in Bq or mSv of anti-CD8 imaging agent concentration in tumor target tissue, blood and other organs of interest with regards to injected dose (ID), derived from measurements of standardized uptake value (SUV) on immunoPET images and direct analysis of blood 89Zr-activity.

    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 posted23 Jul 2019
  2. Study start14 Feb 2019
  3. Primary completion28 Dec 2022
  4. Study completionDec 2024 (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
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04029181
Sponsor's protocol ID
201700848
Status last verified
Feb 2024
First submitted
17 Jun 2019
Last updated
3 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kist de Ruijter L, van de Donk PP, Hooiveld-Noeken JS, Giesen D, Elias SG, Lub-de Hooge MN, Oosting SF, Jalving M, Timens W, Brouwers AH, Kwee TC, Gietema JA, Fehrmann RSN, Fine BM, Sanabria Bohorquez SM, Yadav M, Koeppen H, Jing J, Guelman S, Lin MT, Mamounas MJ, Eastham JR, Kimes PK, Williams SP, Ungewickell A, de Groot DJA, de Vries EGE. Whole-body CD8+ T cell visualization before and during cancer immunotherapy: a phase 1/2 trial. Nat Med. 2022 Dec;28(12):2601-2610. doi: 10.1038/s41591-022-02084-8. Epub 2022 Dec 5.

    PubMed 36471036

  • Ogasawara A, Kiefer JR, Gill H, Chiang E, Sriraman S, Ferl GZ, Ziai J, Bohorquez SS, Guelman S, Wang X, Yang J, Phan MM, Nguyen V, Chung S, Yu C, Tinianow J, Waaijer SJH, De Crespigny A, Marik J, Boswell CA, Zabka T, Staflin K, Williams SP. Preclinical development of ZED8, an 89Zr immuno-PET reagent for monitoring tumor CD8 status in patients undergoing cancer immunotherapy. Eur J Nucl Med Mol Imaging. 2023 Jan;50(2):287-301. doi: 10.1007/s00259-022-05968-6. Epub 2022 Oct 22.

    PubMed 36271158

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Anti-CD8 PET imaging agent in people with Metastatic Cancer and Unresectable Malignant Neoplasm, 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 11 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 May 2024. 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?

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 of adverse events related to tracer administration as assessed by CTCAE v4.0 (time frame: 2 years). The study lists 4 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 NCT04029181, which also lists 2 linked publications.

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 3 May 2024.

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