Hodgkin Lymphoma Clinical Trial
Official title:
A Phase I Study of Positron Emission Tomography (PET/CT) With ⁸⁹Zr-Df-IAB22M2C in Patients With Selected Solid Malignancies (Non Small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC), Squamous Cell Carcinoma Head and Neck (SqCCHN), Melanoma, Merkel Cell Tumor, Renal, Bladder, Hepatocellular, Triple Negative Breast, or Gastroesophageal Cancer) or Hodgkin's Lymphoma
Verified date | September 2018 |
Source | ImaginAb, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | August 16, 2018 |
Est. primary completion date | August 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Honor Health and Imaging Endpoints | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
ImaginAb, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability of 8?Zr-Df-IAB22M2C assessed by local and systemic signs and symptoms of infusion reactions,incidence of adverse events,changes in laboratory test results,dose limiting toxicities,vital signs and 12-lead electrocardiogram findings | From infusion of 8?Zr-Df-IAB22M2C up to 12 weeks | ||
Secondary | Evaluate imaging time window with 8?Zr-Df-IAB22M2C | From infusion of 8?Zr-Df-IAB22M2C through up to Day 6 | ||
Secondary | Evaluate protein dose for imaging with 8?Zr-Df-IAB22M2C | From infusion of 8?Zr-Df-IAB22M2C through up to Day 6 | ||
Secondary | Evaluate the radioactive pharmacokinetics of 8?Zr-Df-IAB22M2C by determining the time-activity curves for serum (% injected dose/liter), AUC, clearance, volume of distribution, Tmax and Cmax. | The data from the actual concentration and the parameters will be summarized descriptively and also presented as subject specific listings. | From infusion of 8?Zr-Df-IAB22M2C through up to Day 6 | |
Secondary | Evaluate the dosimetry of a single dose of 8?Zr-Df-IAB22M2C | Dosimetry will be determined from the 8?Zr-Df-IAB22M2C PET/CT scans obtained during the course of this study at 1-2 hours, 6-8 hours (optional), 24 (± 4 hours), 48 (± 4 hours) hours and 92-144 hours post infusion in patients at the optimal dosing cohort. Regions of interest will be drawn at each PET/CT time point to capture target and major organ uptakes. Once all five PET/CT scans are analyzed, the biologic clearance will be evaluated from the "dynamic" sequence of the scans and the final estimated radiation dose calculated using the clearance seen in the images. The data for dosimetry also comes from Imaging Endpoints. Patterns of radiotracer uptake and estimates of semi-quantitative measurements, using typical SUV (Standardized uptake value) estimates (SUV max; SUV peak; SUV mean) will be presented. The data will be summarized descriptively and will also be presented as subject specific listings. | From infusion of 8?Zr-Df-IAB22M2C through up to Day 6 |
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