irresectable or metastatic solid tumour or a local and resectable head and neck squamous cell carcinoma head and neck SCC PET scan bij solid tumors
Conditions
Interventions
Investigational Medicinal Product:
GEH200520 Injection
For Part A, subjects will receive a single administration of GEH200520
Injection at a mass dose of 1, 2, 4, 8, and 12 or 15 mg.
For Part B, GEH
it is recommended to be injected slowly at a rate up to a maximum of
2 mL/min followed by a 10 mL saline flush (as required based on Investigator
judgment).
GEH200521 (18F) Injection:
For Part A,
due to the increased detection sensitivity
of this scanner, the target dose when scanning using a total-body system is 110
MBq ±10%.
GEH200521 (18F) Injection will be administered 2 to 4 minutes af
it is recommended to be injected
slowly over a period of up to 60 seconds followed by a 10 mL saline flush (as
required based on Investigator judgment).
Comparator Imaging:
GEH200521 (18F) Injecti
Sponsors
GE Healthcare Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: (1) The subject is able and willing to comply with all study procedures as described in the protocol, including the imaging day pre-visit requirements, and has read, signed, and dated an informed consent form prior to any study procedures being performed. (2) The subject is male or female, >=18 years of age. (3) Subject has a body mass index (BMI) >=18 and =12 weeks. (5) Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1. (6) Subject has an irresectable or metastatic solid tumour or a local and resectable head and neck squamous cell carcinoma. (7) Subject is eligible for ICI treatment. (8) Subject has at least 1 measurable tumour lesion documented on CT/magnetic resonance imaging (MRI) RECIST v1.1 during the last 12 months. Previously irradiated lesions should not count as target lesions. (9) Subject has a tumour lesion(s) of which a biopsy can safely be obtained according to standard clinical care procedures. (10) Subject is male, or a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or non-lactating, or if of childbearing potential the results of a serum or urine human chorionic gonadotropin pregnancy test, at screening and on the day of IMP administration (with the result known before IMP administration), must be negative. Women of childbearing potential and males who are sexually active with a partner of childbearing potential must use adequate contraception from Screening until 30 days after IMP administration. Such methods include: hormonal contraception including oral contraceptives; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner; sexual abstinence; adequate barrier method with spermicide (e.g., diaphragm, condom).
Exclusion criteria
Exclusion criteria: (1) Subject is unable to undergo all procedures in the study and/or is unable to remain still and tolerate the imaging procedure. (2) Subject has 12-lead ECG significant findings during screening, per Investigator*s assessment. (3) Subject is not stable due to medical condition or therapy that, in the opinion of the Investigator, could compromise subject safety or protocol objectives. (4) Subject has active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. (5) Subject has a confirmed active COVID-19 infection. (6) Subject has serious non-malignant disease or conditions that, in the opinion of the Investigator, could compromise subject safety or protocol objectives. (7) Subject has B or T cell lymphoma. (8) Subject has brain or bone-marrow metastasis that, in the opinion of the Investigator, could compromise subject safety or protocol objectives. (9) Subject has signs or symptoms of systemic infection within 2 weeks prior to imaging day. (10) Subject has history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins or known allergy to the study IMP ingredients and/or the proposed ICI therapy. (11) Subject has 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 ICI treatment, or that may affect the interpretation of the results or render the subject at high risk from complications. (12) Subject has laboratory values of: I. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal (ULN) or greater than 5 times the ULN in case of liver metastases. II. Bilirubin >3.0 x ULN III. Creatinine clearance <45 mL/min/1.73 m2 IV. Leukocyte count <3,500/mm3 V. Platelet count <100,000/µL (13) Subject has any safety laboratory test results (clinical chemistry, haematology, and urinalysis) that, in the opinion of the Investigator, could compromise subject safety or protocol objectives. (14) Subject has had any major surgery within 4 weeks prior to enrolment or major surgery is scheduled during the study, with the exception of procedures that are part of the study site IIS. (15) Subject has been enrolled in another interventional clinical study within the 30 days before screening for this study, except for the study site IIS. (16) Subject is pregnant or planning to become pregnant or is lactating. (17) Subject has a history of alcohol or drug abuse within the last year. (18) Subject has had treatment with systemic immunostimulatory agents (including but not limited to interferons [IFNs] or interleukin-2 [IL-2]) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to dosing with the IMP. (19) Subject has had treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor agents) within 2 weeks prior to dosing with the IMP. (20) Subject has received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) that, in the <b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A Primary: • The incidence and severity of AEs per National Cancer Institute*s Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) based on the causality to the IMP. Part B Primary: • Comparison of GEH200521 (18F) Injection uptake between longitudinal PET scans. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A Secondary: • Assessment of the dosimetry estimates and cumulated activity by source region and by entire body including whole blood and excreted urine at timepoints up to 6 hours post-administration of GEH200521 (18F) Injection. • Assessment of qualitative and quantitative uptake of GEH200521 (18F) Injection in images, including signal to background ratios and uptake in regions of interest. • Determination of GEH200520 Injection optimal dose will be based on totality of evidence captured during Part A assessments such as safety and tolerability, imaging quality, and PK profile. • The PK parameters assessed for GEH200520 Injection and GEH200521 (18F) Injection combined concentrations will be: o Area under the curve (AUC) o Maximum serum concentration (Cmax) o CL o V o t1/2 • Assessment of AEs/serious AEs (SAEs)/AEs of special interest (AESIs) and changes in physical examination, laboratory variables, ECG, and vital signs between baseline and the end of study. • Incidence of treatment-induced ADA responses following administration of GEH200520 Injection with GEH200521 (18F) Injection and the impact of ADA on safety profile of IMPs. Part B Secondary: • AEs/SAEs/AESIs, physical examination, laboratory variables, ECG, vital signs. • Evaluate inter- and intra-subject variability in biodistribution and tumour uptake of GEH200521 (18F) Injection, including normal tissue distribution. • Evaluate the uptake of GEH200521 (18F) Injection versus sample biopsy/lesion findings, when available, across inter- and intra-subject populations. • Assess changes in tumour uptake of GEH200521 (18F) Injection in comparison to CT RECIST v1.1 criteria and/or [18F]-FDG scans, when available. • The following PK parameters will be assessed for GEH200520 Injection and GEH200521 (18F) Injection combined concentrations: o AUC o Cmax o CL o V o t1/2 • Incidence of treatment-induced ADA responses following administration of GEH200520 Injection with GEH2 | — |
Countries
Netherlands
Outcome results
None listed