A Phase 1a/1b, Multi-Centre, Open-Label, Dose-Escalation and Dose-Expansion Study in Patients with Solid Tumour Malignancies to Evaluate GEH200520 Injection / GEH200521 (18F) Injection Safety and Tolerability, Positron Emission Tomography Imaging, Pharmacokinetics, and Changes in Imaging after Treatment
- Conditions
- irresectable or metastatic solid tumour or a local and resectable head and neck squamous cell carcinomahead and neck SCCPET scan bij solid tumors
- Registration Number
- NL-OMON53493
- Lead Sponsor
- GE Healthcare Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
(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 <=30 kg/m2.
(4) Subject has a life expectancy >=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).
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part A<br /><br>Primary:<br /><br>• The incidence and severity of AEs per National Cancer Institute*s Common<br /><br>Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) based on the<br /><br>causality to the IMP.<br /><br><br /><br>Part B<br /><br>Primary:<br /><br>• Comparison of GEH200521 (18F) Injection uptake between longitudinal PET<br /><br>scans.</p><br>
- Secondary Outcome Measures
Name Time Method