Clinical trial NCT04841421: Clinical Study on PET Imaging, Distribution and PK of 89Zr-CD147 in Patients With Solid Tumors
Official title: Clinical Study on Positron Emission Tomography (PET) Imaging, Distribution and Pharmacokinetics of 89 Zirconium (Zr)-CD147 in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Solid Tumor
Lead sponsor: Sinotau Pharmaceutical Group
Sponsor class: INDUSTRY
First posted: 2021-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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 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.

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 benefit from a particular therapy and monitor the therapy outcome.

Eligibility criteria: Inclusion Criteria:

1. Patients must be between 18 and 70 years old (including 18 and 70 years old), male or female;
2. Patients with advanced solid tumors (stage IV): non-small cell lung cancer (NSCLC); Gastric adenocarcinoma; Colorectal adenocarcinoma, etc ;
3. Patients must have an ECOG performance status of 0-1;
4. Patients must have a life expectancy ≥ 12 weeks;
5. 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;
6. Patients must have ≥1 measurable lesion according to RECIST1.1 criteria;
7. 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.;
8. Patients must have the ability to understand and sign an approved ICF.

Exclusion Criteria:

1. 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;
2. Primary central nervous system tumor;
3. HBV DNA≥1000 copies/ml;
4. HCV-RNA≥1000 copies/ml;
5. People with positive antibodies to HIV or syphilis;
6. Patients with acute or subacute intestinal obstruction, or a history of inflammatory bowel disease;
7. Women who are pregnant, breastfeeding or planning pregnancy;
8. People who are known to be allergic to the study preparation or its auxiliary materials;
9. People with a history of psychotropic substance abuse and inability to get rid of it or mental disorders;
10. Patients who cannot lie for half an hour;
11. Patients who are allergic to any component of the imaging agent or antibody;
12. Patients who cannot accept PET/CT imaging;
13. Situations that other researchers consider unsuitable to participate in the trial.

Primary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: Day 0-7
measure: standardized uptake value ratio (SUVR)
timeFrame: Day 0-7
measure: Radiation dose
timeFrame: Day 0-7
Secondary outcomes:
measure: Terminal Half Time (T1/2)
timeFrame: Day 0-7
measure: Clearance (CL)
timeFrame: Day 0-7
measure: Peak Plasma Concentration (Cmax)
timeFrame: Day 0-7
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Day 0-7
measure: Distribution (dL)
timeFrame: Day 0-7
Other outcomes:
Locations:
Study officials:
References: