⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2018-08-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImaginAb, Inc.

Criteria

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.