Phase
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
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Amsterdam UMC
Amsterdam 2759794,
NetherlandsSite Not Available
UMC Groningen
Groningen,
NetherlandsSite Not Available
UMC Groningen
Groningen 2755251,
NetherlandsActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.