Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- To estimate the intensity and distribution in critical and non-critical organs.
Study Overview
Brief Summary
Tumor Imaging of I-124 PGN65 in Solid Tumors
Detailed Description
Up to 12 patients (6 men and 6 women) will be enrolled in this open-label, single-arm, tumor imaging and dosimetry study of I-124 PGN650 in solid tumors. All eligible patients who give written, informed consent and meet all inclusion criteria and no exclusion criteria, and whose laboratory results are within specified limits at the screening visit, will be enrolled. All study subjects will receive a single intravenous (IV) dose of I-124 PGN650. Study subjects will have whole body PET/CT imaging at three different timepoints with all patients having PET/CT at 0 to 60 minutes after injection of I-124 PGN650. Study subjects will then be assigned to either a 3 to 5-hour or 6 to 8-hour timepoint and either an 18 to 26 hour or 42 to 52 hour post-injection timepoint. Tumor and whole body radioactivity distribution will be measured.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
I-124 PGN650 for PET/CT
Intervention: I-124 PGN650 for PET/CT (Drug)
Outcomes
Primary Outcomes
To estimate the intensity and distribution in critical and non-critical organs.
Time Frame: Day 3
Secondary Outcomes
- The presence of tumor imaging using I-124 PGN650 as a PS-targeting agent.(Day 1, Day 2 and Day 3)
- Demonstrate the safety of tumor imaging in patients with solid cancers.(Day 1, Day 2 and Day 3)