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

Clinical Study on Positron Emission Tomography (PET) Imaging, Distribution and Pharmacokinetics of 89 Zirconium (Zr)-CD147 in Patients With Solid Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: 89Zr-CD147

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Yue Chen, PHD; Phone Number: 13700989831; Email: chenyue5523@126.com
• Study Contact Backup: Name: Lin Qiu, PHD; Phone Number: 15984011133; Email: qiulin17111210041@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 89Zr-CD147 1mCi±10% 10mg dose group; The activity administered was 1mCi±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.
Experimental: 89Zr-CD147 3mCi±10% 10mg dose group; The activity administered was 3mCi±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.
Experimental: 89Zr-CD147 5mCi±10% 10mg dose group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized uptake value (SUV)	Standardized uptake value of tumor	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	Day 0-7
Radiation dose	Radiation dose of whole body and major tissues / organs of subjects after administration	Day 0-7

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sinotau Pharmaceutical Group

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: February 6, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: STB017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No