At a glance
ClinicalIndex Comparison Record- ✓Advanced or metastatic melanoma, NSCLC, renal cell carcinoma, or squamous cell carcinoma of head/neck
- ✓Scheduled to begin standard-of-care immunotherapy
- ✓At least one non-radiated, measurable lesion on CT/MRI (RECIST 1.1) or FDG-avid on FDG-PET within 45 days prior to first tracer infusion
- ✓At least one non-cutaneous, accessible lesion eligible for biopsy
- ✕Single RECIST measurable lesion if biopsy would interfere with RECIST response assessment
- ✕Splenic disorders or history of splenectomy that could compromise protocol objectives
- ✕Serious nonmalignant disease or conditions compromising protocol objectives
- ✕Pregnant women or nursing mothers
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Open Label, Multi-Dose Study of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for Positron Emission Tomography (PET/CT) in Patients With Selected Advanced or Metastatic Solid Malignancies Who Are Scheduled to Receive Standard-of-Care Immunotherapy Only, As Single Agent or in Combination
In Brief
A Phase 2 clinical trial evaluating ⁸⁹Zr-Df-IAB22M2C for Positron-Emission Tomography and Metastatic Solid Tumors. Completed, enrolled 52 participants across 15 sites.
Detailed Summary
The purpose of this study is to evaluate the safety of repeat doses ⁸⁹Zr-Df-IAB22M2C and to establish the relationship between ⁸⁹Zr-Df-IAB22M2C PET/CT lesion uptake with CD8+ cells by immunohistochemical staining in patients with selected advanced and metastatic solid malignancies who are scheduled to receive standard of care immunotherapy. The study will also evaluate uptake of ⁸⁹Zr-Df-IAB22M2C by PET/CT in patients at baseline and on immunotherapy.
Study Details
Timeline
Interventions
⁸⁹Zr-Df-IAB22M2C CD8 T cell tracer for Positron Emission Tomography (PET)