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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04841421
• Other study ID #: STB017
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 1, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: April 2021
• Source: Sinotau Pharmaceutical Group
• Contact: Yue Chen, PHD
• Phone: 13700989831
• Email: chenyue5523[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sinotau Pharmaceutical Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized uptake value (SUV)	Standardized uptake value of tumor	Day 0-7
Primary	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
Primary	Radiation dose	Radiation dose of whole body and major tissues / organs of subjects after administration	Day 0-7
Secondary	Terminal Half Time (T1/2)	Pharmacokinetic parameters	Day 0-7
Secondary	Clearance (CL)	Pharmacokinetic parameters	Day 0-7
Secondary	Peak Plasma Concentration (Cmax)	Pharmacokinetic parameters	Day 0-7
Secondary	Area under the plasma concentration versus time curve (AUC)	Pharmacokinetic parameters	Day 0-7
Secondary	Distribution (dL)	Pharmacokinetic parameters	Day 0-7