89Zr-KN035 PET Imaging in Patients With Advanced Solid Tumors

Not Applicable

• Conditions: Solid Tumor, Adult

• Registration Number: NCT03638804
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

This is a single arm study by using 89Zr-labeled KN035 (89Zr-KN035) PET imaging to evaluate the biodistribution and target lesion uptake of 89Zr-KN035 in patients with PD-L1 positive advanced solid tumors.

Detailed Description

The overall purpose of the study is to evaluate the biodistribution and target lesion uptake of 89Zr-KN035 in patients with PD-L1 positive advanced solid tumors by using PET imaging. Safety will be observed after 89Zr-KN035 injection, and radiation dosimetry of 89Zr-KN035 will be calculated.

Study Timeline

• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-20
• Study Start: 2018-11-12
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-04
• Last Update Posted: 2018-12-05
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans	6 months

Secondary Outcome Measures

Name	Time	Method
Number of adverse events as assessed by CTCAE v4.03	6 months	All adverse events will be assessed by CTCAE v 4.03 and evaluated if treatment-related or not.
Number of changes in vital signs as accessed by CTCAE v4.03	6 months	Vital signs (heart rate, respiratory rate, blood pressures and body temperature) data will be collected by time. Significant changes will be assessed by CTCAE v4.03.
Number of changes in laboratory test results as accessed by CTCAE v4.03	6 months	Laboratory tests (blood, urine) will be conducted by time. Significant changes will be assessed by CTCAE v 4.03.

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China