PET scan
Diagnostic TestParticipants will be imaged up to 4 time points post-injection to allow for biodistribution and dosimetry determination
NCT Number: NCT05737615
The purpose of this study is to find the highest safe dose of hu5B1-TCO and the best dosing schedule of hu5B1-TCO and 64Cu-Tz-SarAr for finding cancer cells that are CA19-9 positive. This study will also help to find out how much radiation the body is exposed to when 64Cu-Tz-SarAr is used, and provide information on the way the body absorbs, distributes, and gets rid of 64Cu-Tz-SarAr.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients will be eligible for enrollment if they fulfill the following criteria:
Patient with solid tumors increased serum CA19-9 serum level greater than ULN or CA19-9 positive biopsy
Exclusion criteria
Patients will be excluded from the study if they fulfill any of the following criteria:
a. Subjects and their partners with reproductive potential must agree to use an effective form of contraception during the study and for 1 week following the study treatment.
Participants will be imaged up to 4 time points post-injection to allow for biodistribution and dosimetry determination
On study day 0, a single slow infusion of hu5B1-TCO will be administered intravenously. Subsequently, either 3 days (n = 3) or 5 days (n = 3) later, a single slow infusion of 64Cu-Tz-SarAr will be administered intravenously.
On study day 0, a single slow infusion of hu5B1-TCO will be administered intravenously. Subsequently, either 3 days (n = 3) or 5 days (n = 3) later, a single slow infusion of 64Cu-Tz-SarAr will be administered intravenously.
All participants receiving 64Cu-Tz-SarAr will have serial blood samples drawn.
Time frame: 28 months
The serial quantitative data obtained over the various organs of interest (heart, liver, spleen, kidney, lung and any other organ that exhibits uptake) will be collected
Memorial Sloan Kettering Cancer Center
Other
A Phase I Study of Pretargeted PET Imaging Using 64Cu-Tz-SarAr and a Trans-Cyclooctene-Modified Humanized 5B1 Immunoconjugate (hu5B1-TCO) in Patients With Pancreatic, Bladder Cancer, Gastrointestinal Malignancies or Solid Tumors With Elevated CA19-9
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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