Clinical trial NCT05471271: IL-2 PET Imaging in Advanced Solid Tumours
Official title: An Open Label Pilot Study of [18AlF]-RESCA-IL2 (Interleukin-2 PET Tracer) for Positron Emission Tomography Imaging in Patients Treated With Immune Checkpoint Inhibitors.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Solid Tumor
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an investigator-initiated, single-center, open-label clinical trial designed to evaluate the safety and PK of the PET tracer \[18F\]AlF-RESCA-IL2 in patients prior to and during treatment.


Eligibility 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 (\< 1% per year) when used consistently and correctly)).

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.

Primary outcomes:
measure: Incidence of adverse events related to [18F]-AlF-RESCA-IL2 administration as assessed by CTCAE v5.0
timeFrame: 2 years
measure: Non-displaceable binding potential (BPND)
timeFrame: 2 years
measure: Total volume of distribution (VT) of the tracer in the tumour
timeFrame: 2 years
measure: Biodistribution of [18F]-AlF-RESCA-IL2
timeFrame: 2 years
Secondary outcomes:
measure: Correlation of 18F-AlF-RESCA-IL2 uptake in tumours, with T cell infiltration in tumour biopsy samples, as determined by IHC.
timeFrame: 2 years
measure: Correlation of 18F-AlF-RESCA-IL2 PET measurements with radiologic response to treatment, according to (i)RECIST v1.1 criteria.
timeFrame: 2 years
measure: Assessment of changes in tumour and normal organ tracer uptake after 2 weeks of treatment, expressed as standardized uptake values.
timeFrame: 2 years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References: