An open label pilot study of [18F]AlF-RESCA-IL2 (Interleukin-2 PET tracer) for positron emission tomography imaging in patients treated with immune checkpoint inhibitors
- Conditions
- cutaneous squamous cell carcinomahead and neck squamous cell carcinomanon-small-cell lung cancerrenal cell carcinomaurothelial cell carcinoma10027656
- Registration Number
- NL-OMON53936
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 14
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 (< 1% per year) when used consistently and correctly)).
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. Active HIV, Hepatitis-B or Hepatitis-C infection.
4. 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.
5. Altered mental status, or any psychiatric condition that would prohibit the
understanding or rendering of informed consent.
6. Sponsor employee/member of the clinical site study team and/or his or her
immediate family
7. Pregnant or lactating females.
8. Concurrent use of systemic corticosteroids > 10 mg daily prednisone
equivalent.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Safety evaluation through summaries of adverse events per NCI CTCAE v5.0<br /><br>criteria, changes in laboratory test results and changes in vital signs after<br /><br>exposure to [18F]AlF-RESCA-IL2<br /><br>• Evaluation of tumour [18F]AlF-RESCA-IL2 uptake by measuring standardised<br /><br>uptake values in tumour lesions.<br /><br>• Evaluation of [18F]AlF-RESCA-IL2 biodistribution in cancer patients on the<br /><br>PET images by measuring standardised uptake values in healthy tissues and<br /><br>organs.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Correlation of [18F]AlF-RESCA-IL2 uptake in tumours, with T cell infiltration<br /><br>in tumour biopsy samples, as determined by IHC.<br /><br>• Correlation of [18F]AlF-RESCA-IL2 PET measurements with radiologic response<br /><br>to treatment, according to (i)RECIST v1.1 criteria.<br /><br>• Assessment of changes in tumour and normal organ tracer uptake after 2 weeks<br /><br>of treatment, expressed as standardised uptake values.</p><br>