Clinical Study on PET Imaging, Distribution and PK of 89Zr-CD147 in Patients With Solid Tumors

Early Phase 1

• Conditions: Solid Tumor
• Interventions: Drug: 89Zr-CD147

• Registration Number: NCT04841421
• Lead Sponsor: Sinotau Pharmaceutical Group

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.

Study Timeline

• Study First Submitted: 2021-02-06
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-07
• Last Update Submitted: 2021-04-07
• Study First Posted: 2021-04-12
• Last Update Posted: 2021-04-12
• Study Start: 2021-05-01
• Primary Completion: 2023-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
89Zr-CD147 1mCi±10% 10mg dose group	89Zr-CD147	The activity administered was 1mCi±10% and the mass of radiolabeled CD147 was 10 mg.
89Zr-CD147 3mCi±10% 10mg dose group	89Zr-CD147	The activity administered was 3mCi±10% and the mass of radiolabeled CD147 was 10 mg.
89Zr-CD147 5mCi±10% 10mg dose group	89Zr-CD147	The activity administered was 5mCi±10% and the mass of radiolabeled CD147 was 10 mg.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value (SUV)	Day 0-7	Standardized uptake value of tumor
standardized uptake value ratio (SUVR)	Day 0-7	The ratio of the standardized uptake value of the tumor or suspected tumor lesion to the standardized uptake value of normal tissue
Radiation dose	Day 0-7	Radiation dose of whole body and major tissues / organs of subjects after administration

Secondary Outcome Measures

Name	Time	Method
Distribution (dL)	Day 0-7	Pharmacokinetic parameters
Terminal Half Time (T1/2)	Day 0-7	Pharmacokinetic parameters
Clearance (CL)	Day 0-7	Pharmacokinetic parameters
Peak Plasma Concentration (Cmax)	Day 0-7	Pharmacokinetic parameters
Area under the plasma concentration versus time curve (AUC)	Day 0-7	Pharmacokinetic parameters