⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma
Completed · Phase 1
Conditions studied: Positron-Emission Tomography, Immunomodulation, Metastatic Solid Malignancies, Hodgkin Lymphoma
In brief
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.
Key facts
- Study ID
- NCT03107663
- Run by
- ImaginAb, Inc.
- People needed
- 15
- Starts
- 2017-06-19
- Expected to finish
- 2018-08-16
- Last updated by the study team
- 2018-09-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Patients meeting any of the following criteria will not be eligible for study entry:
- 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
- Pregnant women or nursing mothers
- Hepatic laboratory values:
- Bilirubin > 1.5 x ULN (institutional upper limits of normal)
- Albumin < 2 g/dL
- Other local safety laboratory test results (clinical chemistry and hematology) are determined to be exclusionary by the Investigator.
- Known sensitivity to glutamic acid or glutamate.
Where it is running
- Honor Health and Imaging Endpoints — Scottsdale, Arizona, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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