IL-2 PET Imaging in Advanced Solid Tumours

NCT05471271 | Terminated DMC

• 1 other identifier: 202100912
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Incidence of adverse events related to [18F]-AlF-RESCA-IL2 administration as assessed by CTCAE v5.0

  Safety assessment through summaries of adverse events, changes in laboratory test results (if evaluation is indicated) and changes in vital signs. Adverse event data will be recorded and summarized according to NCI CTCAE v5.0

  2 years

• Non-displaceable binding potential (BPND)

  To evaluate the pharmacokinetic behaviour of 18F-AIF-RESCA-IL2 through activity in venous blood samples, dynamic imaging, and pharmacokinetic modeling.

  2 years

• Total volume of distribution (VT) of the tracer in the tumour

  To evaluate the pharmacokinetic behaviour of 18F-AIF-RESCA-IL2 through activity in venous blood samples, dynamic imaging, and pharmacokinetic modeling.

  2 years

• Biodistribution of [18F]-AlF-RESCA-IL2

  Evaluation of \[18F\]AlF-RESCA-IL2 biodistribution in cancer patients on the PET images by measuring standardized uptake values in tumours, healthy tissues and organs.

  2 years

Secondary Outcomes (3)

• Correlation of 18F-AlF-RESCA-IL2 uptake in tumours, with T cell infiltration in tumour biopsy samples, as determined by IHC.

  2 years

• Correlation of 18F-AlF-RESCA-IL2 PET measurements with radiologic response to treatment, according to (i)RECIST v1.1 criteria.

  2 years

• Assessment of changes in tumour and normal organ tracer uptake after 2 weeks of treatment, expressed as standardized uptake values.

  2 years

Study Arms (1)

[18AlF]-RESCA-IL2 PET imaging

OTHER

Other: [18F]AlF-RESCA-IL2 PET scan

Interventions

[18F]AlF-RESCA-IL2 PET scan OTHER

Patients will undergo \[18F\]AlF-RESCA-IL2 PET imaging twice; the first \[18F\]AlF-RESCA-IL2 PET scan will be performed at baseline, before starting therapy. The second \[18F\]AlF-RESCA-IL2 PET scan will be performed after 2 weeks of treatment

[18AlF]-RESCA-IL2 PET imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 22, 2022
• Study Start: October 2, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)