Clinical Trial · NCT03107663

⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma

Overview

To determine the safety and feasibility of 89Zr-Df-IAB22M2C as an immunoPET tracer; determine the best time window and protein dose for imaging; determine the pharmacokinetic (PK) and biodistribution of the probe; and to determine imaging parameters for optimal lymphoid and tumor visualization.

Sponsor

Imagine AB, Inc.

Phase

Phase 1

ClinicalTrials.gov

NCT03107663

Eligibility

Inclusion

At least 1 measurable lesion documented on CT/MRI (RECIST criteria 1.1)
Patients with selected solid malignancies (NSCLC, SCLC, SqCCHN, melanoma, merkel cell tumor, renal, bladder, hepatocellular, triple negative breast, or gastroesophageal cancer) or Hodgkin's lymphoma
For men and women of child-bearing potential, use of effective contraceptive methods during the study
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix B: ECOG Scoring)
Willingness and ability to comply with all protocol required procedures

Exclusion

Bilirubin \> 1.5 x ULN (institutional upper limits of normal)
Known sensitivity to glutamic acid or glutamate.
Patients who have any splenic disorders that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
Hepatic laboratory values:
Patients who are currently receiving any other investigational agent
Pregnant women or nursing mothers
Known infection with human immunodeficiency virus (HIV)
Patients who have had splenectomy.
Albumin \< 2 g/dL
Patients meeting any of the following criteria will not be eligible for study entry:
Other local safety laboratory test results (clinical chemistry and hematology) are determined to be exclusionary by the Investigator.
Serious nonmalignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives