patients with stage IV non-small-cell lung carcinoma (NSCLC), renal cell carcinoma (RCC), CSCC, urothelial cell cancer (UCC), and head and neck squamous cell carcinoma (HNSCC), eligible for ICI therapy (anti-PD-L1, anti-PD-1 and/or anti-CTLA4)
Conditions
Interventions
Product Name: [18F]AlF-RESCA-IL2
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [18F]AlF-RESCA-IL2
CAS Number: 8000048-25-1
Current Sponsor code: [18F]AlF-RESCA-IL2
Other descriptiv
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years at the time of signing informed consent. 2. Patients with histologically confirmed diagnosis of locally advanced or metastatic solid cancer, eligible for ICI therapy as part of routine care. 3. At least 1 lesion that is accessible per investigator’s assessment and eligible for biopsy according to standard clinical care procedures. 4. Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions except for lesions that have progressed after radiotherapy. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Life expectancy = 12 weeks. 7. Signed informed consent. 8. Willingness and ability to comply with all protocol required procedures. 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 (=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to [18F]AlF-RESCA-IL2 injection. 2. Evidence of an active infection that requires systemic antibiotics within 2 weeks prior to [18F]AlF-RESCA-IL2 injection. 3. 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 [18F]AlF-RESCA-IL2, or that may affect the interpretation of the results or render the patient at high risk from complications. 4. Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. 5. Sponsor employee/member of the clinical site study team and/or his or her immediate family 6. Pregnant or lactating females. 7. Concurrent use of systemic corticosteroids > 10 mg daily prednisone equivalent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate safety of repeat doses of [18F]AlF-RESCA-IL2. •To evaluate pharmacokinetics (PK) of [18F]AlF-RESCA-IL2 binding in the tumour in patients prior to and during treatment with an immune checkpoint inhibitor. •To evaluate whole body distribution of [18F]AlF-RESCA-IL2 in cancer patients. ;Secondary Objective: •To assess changes in tumour and normal organ uptake after 2 weeks of immune checkpoint inhibitor therapy. •To determine whether changes in visual and semi-quantitative [18F]AlF-RESCA-IL2 PET measurements correlate with RECIST v1.1. radiology responses. •To correlate tracer uptake with immune cell infiltration in the tumour as assessed by immunohistochemistry. ;Primary end point(s): •Safety evaluation through summaries of adverse events per NCI CTCAE v5.0 criteria, changes in laboratory test results and changes in vital signs after exposure to [18F]-AlF-RESCA-IL2 •To evaluate the PK of 18F-AlF-RESCA-IL2 binding in the tumor by measuring radioactivity levels in blood by venous blood sampling and tracer uptake in the tumour by dynamic PET imaging. The whole blood and metabolite-corrected plasma radioactivity vs. time curves and the time-radioactivity curve of the tumour are used as input functions for compartment modelling of tracer kinetics. Outcome parameters of pharmacokinetic modelling are the non-displaceable binding potential (BPND) or the total volume of distribution (VT) of the tracer in the tumour, assuming the tracer will also display reversible binding in humans. The “gold standard” parameters BPND or VT will be correlated to the standardized uptake values (SUV) of the tracer in the tumour. In this manner, the use of the semi-quantitative parameter SUV, which can be sensitive to confounding factors, can be validated for use in further studies with this tracer. •Evaluation of 18F-AlF-RESCA-IL2 biodistribution in cancer patients on the PET images by measuring standardized uptake values in healthy tissues and organs.;Timepoint(s) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Correlation of 18F-AlF-RESCA-IL2 uptake in tumours, with T cell infiltration in tumour biopsy samples, as determined by IHC. • Correlation of 18F-AlF-RESCA-IL2 PET measurements with radiologic response to treatment, according to (i)RECIST v1.1 criteria. • Assessment of changes in tumour and normal organ tracer uptake after 2 weeks of treatment, expressed as standardized uptake values. ;Timepoint(s) of evaluation of this end point: These endpoints will be evaluated throughout the trial | — |
Countries
Netherlands
Contacts
Public ContactResearchcoordinator Medical Oncolog
University Medical Center Groningen
Outcome results
None listed