Clinical trial · Interventional
ImmunoPET With an Anti-CD8 Imaging Agent
ImmunoPET Imaging With ZED88082A in Patients Before and During Treatment With 1) MPDL3280A or 2) PD-1 Antibody Plus or Minus Ipilimumab
NCT04029181CI-TRIAL-00076725unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Unresectable Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-CD8 PET imaging agent | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose finding cohort
- description
- In 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.
- interventionNames
- Other: Anti-CD8 PET imaging agent
- type
- EXPERIMENTAL
- label
- Feasibility cohort
- description
- The 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.
- interventionNames
- Other: Anti-CD8 PET imaging agent
Primary outcomes (4)
- measure
- Incidence of adverse events related to tracer administration as assessed by CTCAE v4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. Tumor lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures. 3. Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions. 4. Signed informed consent. 5. Age ≥18 at the time of signing informed consent. 6. Life expectancy ≥12 weeks. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 8. Ability to comply with the protocol. 9. 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). Exclusion Criteria: 1. 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). 2. Signs or symptoms of infection within 2 weeks prior to anti-CD8 imaging agent injection. 3. Prior immune checkpoint inhibitor treatment, including but not limited to anti-PD1 and anti-PD-L1 therapeutic antibodies. 4. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins 5. 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. 6. Pregnant or lactating women.
References
Publications (2)
- DERIVEDKist 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. PMID 36471036
- DERIVEDOgasawara 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. PMID 36271158