TheranosticTrials.org

Clinical Trial · NCT03802123

⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for PET/CT in Patients With Metastatic Solid Tumors

Overview

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.

Sponsor

Imagine AB, Inc.

Phase

Phase 2

Contacts

Ron Korn, MD, PhD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT03802123

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • • At least 1 non radiated measurable lesion documented on CT/, MRI (per RECIST criteria 1.1) or are FDG avid on FDG-PET within 45 days prior to first 89Zr-Df-IAB22M2C (CD8 PET Tracer) infusion.
  • At least 1 non-cutaneous lesion that is accessible, per investigator's assessment, and eligible for biopsy. If only a single RECIST measurable lesion is present, investigator to determine if the tumor biopsy could interfere with RECIST assessments of response.
  • For men and women of child-producing potential, use of effective double barrier contraceptive methods during the study, up to 30 days after the last administration of the investigational product.
  • Participants will be eligible for enrollment in the study only if they meet ALL of the following criteria:
  • Willingness and ability to comply with all protocol required procedures.
  • Meeting all clinical safety lab values per institution's standard of care, or Investigator's discretion, for patients receiving cancer treatment.

Exclusion

  • Serious nonmalignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
  • Pregnant women or nursing mothers.
  • Subjects will NOT be eligible for enrollment in the study if they meet ANY of the following criteria:
  • Patients who have any splenic disorders, or had splenectomy, that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
  • Patients with a single RECIST measurable lesion, biopsy of which, per investigator's assessment, is likely to interfere with RECIST assessments of response.
  • 5\. Life expectancy \< 6 months