CompletedPhase 1NCT03107663

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

StatusCompleted
PhasePhase 1
U.S. locations3
SponsorImaginAb, Inc.
01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Phase 1
Sponsor
ImaginAb, Inc.
Interventions being studied
Drug: ⁸⁹Zr-Df-IAB22M2C Infusion
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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