NCT06534190 CD8 PET Imaging in Metastatic Solid Tumours
| NCT ID | NCT06534190 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Medical Center Groningen |
| Condition | Locally Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-03-11 |
| Primary Completion | 2028-11 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a multi-center, single-arm trial designed to evaluate the safety and imaging characteristics of 89Zr-Df-crefmirlimab in patients with locally advanced or metastatic solid tumours prior to and during PD-1 antibody therapy.
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 types who, according to the opinion of the principal investigator, based on available clinical data, may benefit from anti-PD1 antibody therapy. 3. Disease progression following first-line therapy or any subsequent treatment line or no superior standard line of therapy available. 4. At least 1 lesion that is accessible per investigator's assessment and eligible for biopsy according to standard clinical care procedures. 5. 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 administered at least 3 months earlier. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Life expectancy ≥ 12 weeks. 8. Adequate organ and bone marrow function as defined below: 1. H