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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 18, 2018 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
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
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.