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

NCT04841421 | Unknown Early Phase 1

• 1 other identifier: STB017
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Terminal Half Time (T1/2)

  Day 0-7

• Clearance (CL)

  Day 0-7

• Peak Plasma Concentration (Cmax)

  Day 0-7

• Area under the plasma concentration versus time curve (AUC)

  Day 0-7

• Distribution (dL)

  Day 0-7

Study Arms (3)

89Zr-CD147 1mCi±10% 10mg dose group

EXPERIMENTAL

The activity administered was 1mCi±10% and the mass of radiolabeled CD147 was 10 mg.

Drug: 89Zr-CD147

89Zr-CD147 3mCi±10% 10mg dose group

EXPERIMENTAL

The activity administered was 3mCi±10% and the mass of radiolabeled CD147 was 10 mg.

Drug: 89Zr-CD147

89Zr-CD147 5mCi±10% 10mg dose group

EXPERIMENTAL

The activity administered was 5mCi±10% and the mass of radiolabeled CD147 was 10 mg.

Drug: 89Zr-CD147

Interventions

89Zr-CD147 DRUG

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.

89Zr-CD147 1mCi±10% 10mg dose group; 89Zr-CD147 3mCi±10% 10mg dose group; 89Zr-CD147 5mCi±10% 10mg dose group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinotau Pharmaceutical Group: lead

Central Study Contacts

Yue Chen, PHD

CONTACT

13700989831; chenyue5523@126.com

Lin Qiu, PHD

CONTACT

15984011133; qiulin17111210041@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: April 12, 2021
• Study Start: May 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share