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
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.
This is a phase I study of positron emission tomography (PET/CT) with ⁸⁹Zr-Df-IAB22M2C in
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. Up to 24 subjects are planned to be enrolled in this clinical study.
This phase 1 study is a dose escalation study of ⁸⁹Zr-Df-IAB22M2C to evaluate safety,
tolerability, optimal time window and protein dose for imaging, biodistribution, radiation
dosimetry, as well as the ability of ⁸⁹Zr-Df-IAB22M2C to detect CD8+ expressing T cells. The
investigational imaging agent to be administered in this study will be 3.0 (±20%) mCi dose of
⁸⁹Zr-Df-IAB22M2C injected intravenously. Up to six cohorts of up to 6 patients each will be
studied sequentially with dose escalation at 0.2 mg, 0.5 mg, 1.0 mg, 1.5 mg, 5.0 mg, and 10.0
mg total protein doses followed by an optimal dose expansion cohort. Safety as well as
lymphoid visualization (LV) on imaging (i.e. signal in tumor and lymphoid organs including
spleen, lymph nodes and bone marrow) will be evaluated to drive dose
escalation/de-escalation.
At least 2 weeks will separate the ⁸⁹Zr-Df-IAB22M2C administration in the first patient and
subsequent patients of each dose cohort to provide an opportunity to detect any acute
reaction to the study drug and any adverse events. Tracer administration for subsequent
patients in each cohort will be separated by a minimum of 24 hours
Each patient will undergo five (5) post infusion PET/CT scans ( 1 - 2 hours, 6-8 hrs
(optional), 24 ± 4 hours, 48 ± 4 hours and 92 - 144 hours).
Pharmacokinetic blood samples will be drawn at the following timepoints: pre-infusion; then
post-infusion at 5-10 min, 30 (+/-10) min, 60 (+/- 10) min, 120 (+/- 10) min, 240 (+/- 10)
min, 350-490 (+/- 10) min (optional), 24 hrs (visit 3), 48 hrs (visit 4), 92-144 hrs (visit
5). The imaging data collected across the dosing cohort and time series of PET/CT scans will
assess biodistribution, dosimetry, and be used to recommend a protein dose and an optimal
time window for imaging in future studies
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