Status:
UNKNOWN
Clinical Study on PET Imaging, Distribution and PK of 89Zr-CD147 in Patients With Solid Tumors
Lead Sponsor:
Sinotau Pharmaceutical Group
Conditions:
Solid Tumor
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
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 pharma...
Detailed Description
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 bene...
Eligibility Criteria
Inclusion
- Patients must be between 18 and 70 years old (including 18 and 70 years old), male or female;
- Patients with advanced solid tumors (stage IV): non-small cell lung cancer (NSCLC); Gastric adenocarcinoma; Colorectal adenocarcinoma, etc ;
- Patients must have an ECOG performance status of 0-1;
- Patients must have a life expectancy ≥ 12 weeks;
- 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;
- Patients must have ≥1 measurable lesion according to RECIST1.1 criteria;
- For patients who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 6 months after last study drug administration.;
- Patients must have the ability to understand and sign an approved ICF.
Exclusion
- There are any of the following conditions, such as brain metastasis (except for asymptomatic primary or metastatic brain tumors that do not need treatment), carcinomatous meningitis, myocardial infarction (within 6 months before enrollment), unstable angina pectoris, or high risk of uncontrollable arrhythmia, coronary artery bypass grafting, cerebrovascular accident (within 6 months before enrollment), congestive heart failure (cardiac function grade III-IV), pulmonary embolism, deep venous thrombosis, Infections that need to be treated with intravenous antibiotics within 2 weeks, and immunosuppressant therapy after organ transplantation;
- Primary central nervous system tumor;
- HBV DNA≥1000 copies/ml;
- HCV-RNA≥1000 copies/ml;
- People with positive antibodies to HIV or syphilis;
- Patients with acute or subacute intestinal obstruction, or a history of inflammatory bowel disease;
- Women who are pregnant, breastfeeding or planning pregnancy;
- People who are known to be allergic to the study preparation or its auxiliary materials;
- People with a history of psychotropic substance abuse and inability to get rid of it or mental disorders;
- Patients who cannot lie for half an hour;
- Patients who are allergic to any component of the imaging agent or antibody;
- Patients who cannot accept PET/CT imaging;
- Situations that other researchers consider unsuitable to participate in the trial.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04841421
Start Date
May 1 2021
End Date
March 1 2024
Last Update
April 12 2021
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