⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma (NCT03107663) | Clinical Trial Compass
CompletedPhase 1
⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma
United States15 participantsStarted 2017-06-19
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. At least 1 measurable lesion documented on CT/MRI (RECIST criteria 1.1)
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix B: ECOG Scoring)
✓. Age ≥ 18 years
✓. Ability to understand the purposes and risks of the trial and has signed a IRB-approved informed consent form
✓. Willingness and ability to comply with all protocol required procedures
✓. For men and women of child-bearing potential, use of effective contraceptive methods during the study
Exclusion criteria
✕. Known infection with human immunodeficiency virus (HIV)
✕. Serious nonmalignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives
✕. Patients who have had splenectomy.
✕. Patients who have any splenic disorders that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
✕. Patients who are currently receiving any other investigational agent
What they're measuring
1
Safety and tolerability of ⁸⁹Zr-Df-IAB22M2C assessed by local and systemic signs and symptoms of infusion reactions,incidence of adverse events,changes in laboratory test results,dose limiting toxicities,vital signs and 12-lead electrocardiogram findings
Timeframe: From infusion of ⁸⁹Zr-Df-IAB22M2C up to 12 weeks