An Early Phase 1 interventional study of 89Zr-CD147 in Solid Tumor, sponsored by Sinotau Pharmaceutical Group. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-04-12.
Sponsored by Sinotau Pharmaceutical Group · Early Phase 1, Interventional, and Diagnostic
The primary objective of this study is to observe the distribution of 89Zr-CD147 and radiation dosimetry characteristics in patients with solid tumors. The secondary objective is to observe the pharmacokinetic characteristics of 89Zr-CD147 in patients with solid tumors. This study is a single-center, open-lable study, including 89Zr-CD147 1mCi±10%,89Zr-CD147 3mCi±10% and 89Zr-CD147 5mCi±10% dose group. The trial is expected to last for 2 years from the first patient signing the consent form to the end of the trial.
Antibody based positron emission tomography (immuno-PET) imaging is of increasing importance to visualize and characterize tumor lesions. Additionally, it can be used to identify patients who may benefit from a particular therapy and monitor the therapy outcome.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Sinotau Pharmaceutical Group is the lead sponsor of 17 studies on the registry; 7 are open to participants now.
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Patients must have adequate organ function:
White blood cell (WBC) count≥4.0x10\^9/L or absolute neutrophil count (ANC) ≥1.5 x 10\^9/L, Platelets ≥100 x 10\^9/L, Hemoglobin≥ 90g/L ; thrombin time or Activated partial thromboplastin time≤1.5ULN; liver and renal function: Total bilirubin≤1.5ULN (upper limit of normal), Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)≤2.5ULN or ≤5ULN (subjects with liver metastasis), alkaline phosphatase (ALP)≤ 2.5ULN (if there is bone metastasis or liver metastasis ALP≤4.5ULN). Urea (BUN)≤1.5ULN, creatinine≤1.5ULN;
Exclusion Criteria:
The activity administered was 1mCi±10% and the mass of radiolabeled CD147 was 10 mg.
Drug: 89Zr-CD147
The activity administered was 3mCi±10% and the mass of radiolabeled CD147 was 10 mg.
Drug: 89Zr-CD147
The activity administered was 5mCi±10% and the mass of radiolabeled CD147 was 10 mg.
Drug: 89Zr-CD147
The 89Zr-CD147 is a promising positron emission tomography probe and it is possible to select suitable tumor patients with CD147 expression to benefit from anti-CD147 treatment.
Standardized uptake value (SUV)
Standardized uptake value of tumor
Time frame: Day 0-7
standardized uptake value ratio (SUVR)
The ratio of the standardized uptake value of the tumor or suspected tumor lesion to the standardized uptake value of normal tissue
Time frame: Day 0-7
Radiation dose
Radiation dose of whole body and major tissues / organs of subjects after administration
Time frame: Day 0-7
Terminal Half Time (T1/2)
Pharmacokinetic parameters
Time frame: Day 0-7
Clearance (CL)
Pharmacokinetic parameters
Time frame: Day 0-7
Peak Plasma Concentration (Cmax)
Pharmacokinetic parameters
Time frame: Day 0-7
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetic parameters
Time frame: Day 0-7
Distribution (dL)
Pharmacokinetic parameters
Time frame: Day 0-7
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Sinotau Pharmaceutical Group