Overview
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
Inclusion Criteria:
- Age ≥ 18 years at the time of signing informed consent.
- Patients with histologically confirmed diagnosis of locally advanced or metastatic solid cancer, eligible for ICI therapy as part of routine care.
- At least 1 lesion that is accessible per investigator's assessment and eligible for biopsy according to standard clinical care procedures.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Signed informed consent.
- Willingness and ability to comply with all protocol required procedures.
- 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:
- 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.
- Evidence of an active infection that requires systemic antibiotics within 2 weeks prior to [18F]AlF-RESCA-IL2 injection.
- 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.
- Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Sponsor employee/member of the clinical site study team and/or his or her immediate family
- Pregnant or lactating females.
- Concurrent use of systemic corticosteroids > 10 mg daily prednisone equivalent.