⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma
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.
Checked against the public recordLast updated Sep 18, 2018 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- ImaginAb, Inc.
- Interventions being studied
- Drug: ⁸⁹Zr-Df-IAB22M2C Infusion
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 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 2. At least 1 measurable lesion documented on CT/MRI (RECIST criteria 1.1) 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix B: ECOG Scoring) 4. Age ≥ 18 years 5. Ability to understand the purposes and risks of the trial and has signed a IRB-approved informed consent form 6. Willingness and ability to comply with all protocol required procedures 7. For men and women of child-bearing potential, use of effective contraceptive methods during the study Exclusion Criteria: Patients meeting any of the following criteria will not be eligible for study entry: 1. Known infection with human immunodeficiency virus (HIV) 2. Serious nonmalignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives 3. Patients who have had splenectomy. 4. Patients who have any splenic disorders that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives. 5. Patients who are currently receiving any other investigational agent 6. Pregnant women or nursing mothers 7. Hepatic laboratory values: 1. Bilirubin \> 1.5 x ULN (institutional upper limits of normal) 2. Albumin \< 2 g/dL 3. Other local safety laboratory test results (clinical chemistry and hematology) are determined to be exclusionary by the Investigator. 8. Known sensitivity to glutamic acid or glutamate.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Honor Health and Imaging EndpointsScottsdale, Arizona
- Memorial Sloan Kettering Cancer CenterNew York, New York
- University of PennsylvaniaPhiladelphia, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 18, 2018. Always confirm current availability with the study team.