A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies

Last updated: November 14, 2025
Sponsor: GE Healthcare
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Cancer

Treatment

GEH200520 Injection / GEH200521 (18F) Injection - Part A

Dynamic and Static - PET/CT scan

GEH200520 Injection / GEH200521 (18F) Injection - Part B

Clinical Study ID

NCT05629689
GE-269-001
2022-000246-16
2024-515218-42-00
  • Ages > 18
  • All Genders

Study Summary

Part A: The purpose of this part is to assess the safety of GEH200520 and GEH200521 (18F) when administered to patients with solid cancer. Subjects will be requested to complete 3 study visits: 1 screening visit, 1 imaging visit (over 24 hours) and 1 follow-up visit (7 days later). The estimated duration of Part A is 21 days.

Part B: The purpose of this part of the study is to assess the imaging quality and findings as well as the safety and tolerability of GEH200520 and GEH200521 (18F) when administered to patients with cancer before and after immunotherapy treatment.

Subjects will be requested to complete 7 study visits: 1 screening visit, the first imaging visit, followed by 2 immunotherapy immune-checkpoint inhibitor (ICI) treatment visits and 2 additional imaging and 1 follow-up visit. Two late imaging transfer expected post follow up visit. The estimated duration for subject participation in Part B is approximately 64 days.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The subject is able and willing to comply with all study procedures as described inthe protocol, including the imaging day pre-visit requirements, and has read,signed, and dated an informed consent form prior to any study procedures beingperformed.

  • The subject is male or female, ≥18 years of age.

  • Subject has a life expectancy ≥12 weeks.

  • Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

  • Subject has an unresectable or metastatic solid tumour or a local and resectablehead and neck squamous cell carcinoma, or an unresectable stage III-IV melanoma.

  • Subject is eligible for ICI treatment per Investigator judgement.

  • Subject has at least 1 measurable tumour lesion documented on CT/magnetic resonanceimaging (MRI) RECIST v1.1 during the last 12 months.

  • Subject has a tumour lesion(s) of which a biopsy can safely be obtained according tostandard clinical care procedures.

  • Subject is male or female that agrees to adhere to the protocol contraceptionmethods.

Exclusion

Exclusion Criteria:

  • Subject is unable to undergo all procedures in the study and/or is unable to remainstill and tolerate the imaging procedure.

  • Subject has 12-lead ECG significant findings during screening, per Investigator'sassessment.

  • Subject is not stable due to medical condition or therapy that, in the opinion ofthe Investigator, could compromise subject safety or protocol objectives.

  • Subject has active autoimmune disease or a documented history of autoimmune diseaseor syndrome that requires systemic steroids or immunosuppressive agents.

  • Subject has serious non-malignant disease or conditions that, in the opinion of theInvestigator, could compromise subject safety or protocol objectives.

  • Subject has B or T cell lymphoma.

  • Subject has brain or bone-marrow metastasis that, in the opinion of theInvestigator, could compromise subject safety or protocol objectives.

  • Subject has signs or symptoms of systemic infection within 2 weeks prior to imagingday.

  • Subject has history of severe allergic, anaphylactic, or other hypersensitivityreactions to chimeric or humanised antibodies or fusion proteins or known allergy tothe study IMP ingredients and/or the proposed ICI therapy.

  • Subject has any other diseases, metabolic dysfunction, physical examination finding,or clinical laboratory finding giving reasonable suspicion of a disease or conditionthat contraindicates the use of the ICI treatment, or that may affect theinterpretation of the results or render the subject at high risk from complications.

  • Subject has laboratory values out of range per protocol.

  • Subject has any safety laboratory test results (blood chemistry, haematology, andurinalysis) that, in the opinion of the Investigator, could compromise subjectsafety or protocol objectives.

  • Subject has had any major surgery within 4 weeks prior to enrollment.

  • Subject has been enrolled in another interventional clinical study within the 30days before screening for this study, except for the study site IIS.

  • Subject is pregnant or planning to become pregnant or is breastfeeding.

  • Subject has a history of alcohol or drug abuse within the last year.

  • Subject has had treatment with systemic immunostimulatory agents within 6 weeks or 5half-lives of the drug, whichever is shorter, prior to dosing with the IMP.

  • Subject has had treatment with systemic immunosuppressive medications within 2 weeksprior to dosing with the IMP.

  • Subject has received acute, low-dose, systemic immunosuppressant medications that,in the opinion of the Investigator, could compromise protocol objectives.

  • Subject has used systemic corticosteroids to treat inflammatory or autoimmunesymptoms.

Study Design

Total Participants: 50
Treatment Group(s): 4
Primary Treatment: GEH200520 Injection / GEH200521 (18F) Injection - Part A
Phase: 1
Study Start date:
January 27, 2023
Estimated Completion Date:
March 10, 2029

Connect with a study center

  • Amsterdam UMC

    Amsterdam 2759794,
    Netherlands

    Site Not Available

  • UMC Groningen

    Groningen,
    Netherlands

    Site Not Available

  • UMC Groningen

    Groningen 2755251,
    Netherlands

    Active - Recruiting

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