Using IL-2 PET imaging for advanced solid tumors

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.

This study is testing a new imaging method using a special PET scan to see if it can help track how well treatment is working for people with advanced solid tumors.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Medical Center Groningen (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Groningen)
• Trial ID: NCT05471271 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and pharmacokinetics of the PET tracer [18F]AlF-RESCA-IL2 in patients with advanced solid tumors. It is an open-label, single-center study where participants will undergo PET scans before and during their treatment. The aim is to assess how well this imaging technique can help in monitoring the disease and treatment response. Eligible patients must have a confirmed diagnosis of metastatic solid cancer and meet specific criteria for participation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed locally advanced or metastatic solid cancers eligible for immune checkpoint inhibitor therapy.

Not a fit: Patients with non-solid tumors or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the ability to monitor treatment responses in patients with advanced solid tumors.

How similar studies have performed: While the use of PET imaging in oncology is established, the specific application of [18F]AlF-RESCA-IL2 is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Groningen

• University Medical Center Groningen — Groningen, Netherlands (Recruiting)

Study contacts

• Study coordinator: Elisabeth de Vries, MD/PhD

Conditions Metastatic Solid Tumor