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

89Zr-labeled KN035 PET Imaging in Patients With PD-L1positive Advanced Solid Tumors

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.

Study Overview

• Status: Unknown
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Diagnostic test: 89Zr-KN035

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hua Zhang; Phone Number: 86 0512 6778 0040; Email: sdfyy8040@126.com
• Study Contact Backup: Name: Yicong Bian; Phone Number: 86 0512 6778 0467; Email: bianyicong@126.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • Recruiting
      • The First Affiliated Hospital of Soochow University
      • Contact: Yicong Bian; Phone Number: 86 0512 6778 0467; Email: bianyicong@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria (main):

1. Patients voluntarily signed informed consent;
2. Age 18-75, male or female;
3. Patients diagnosed with locally advanced or metastatic solid tumors by histopathology or cytology;
4. Patients with biopsy-proven PD-L1 positive;
5. ECOG score ≤ 0~1; Life expectancy of at least 3 months;
6. Women of childbearing age are required to receive serum pregnancy tests, and only those who have a negative pregnancy test for eligible subjects.

Exclusion Criteria(main):

1. Currently or within the first 28 days before the first dose to participate in another therapeutic clinical trial. If participating in a non-interventional clinical trial, it is not be excluded.
2. Patients with systemic or locally severe infections (CTCAE ≥ 2);
3. Patients with allergies or allergies to any component of the imaging agent or antibody;
4. Patients who cannot undergo PET/CT imaging;
5. Intolerance of intravenous administration, as well as difficulties in venous blood collection (If having the medical history of fainting during acupuncture, and blood phobia);
6. Symptomatic congestive heart failure (NYHA class II-IV) or symptomatic or poorly controlled arrhythmia;
7. Patients have significant QT/QTC interval prolongation during the screening period;
8. Received anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, biological therapy) within 4 weeks prior to first dose;
9. Patents have not recovered to CTCAE grade 0 or 1 from the adverse events due to cancer therapeutics administered;
10. Previously received CD137 agonist or immune checkpoint blocking therapy;
11. Patients with diabetes who have a fasting blood glucose greater than 10 mmol/L;
12. HIV antibody positive, active hepatitis B/C, and TB positive;
13. Patients are regular users (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol);
14. Patients with symptomatic ascites, pleural effusion, or hydropericardium;
15. Pregnant or lactating women, or planning to become pregnant or have children during this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 89Zr-KN035 injection	Diagnostic test: 89Zr-KN035; Single injection of 89Zr labeled KN035 in subjects to observe KN035 affinity in PD-L1 expressed Solid tumors by using PET imaging.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events as assessed by CTCAE v4.03	All adverse events will be assessed by CTCAE v 4.03 and evaluated if treatment-related or not.	6 months
Number of changes in laboratory test results as accessed by CTCAE v4.03	Laboratory tests (blood, urine) will be conducted by time. Significant changes will be assessed by CTCAE v 4.03.	6 months
Number of changes in vital signs as accessed by CTCAE v4.03	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.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum serum concentration of 89Zr-KN035 (Cmax)	Blood samples will be collected and assessed by timepoints.	6 months
Time to Maximum Concentration of 89Zr-KN035 (Tmax)	Blood samples will be collected and assessed by timepoints.	6 months
Calculation of radiation dosimetry of 89Zr-KN035		6 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University
• Collaborators: MITRO Biotech Co., Ltd.
• Investigators: Principal Investigator: liyan Miao, PhD, The First Affiliated Hospital of Soochow University; Principal Investigator: Jianan Huang, PhD, The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: PET; PD-L1; 89Zr; KN035
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: AMS-2017-007-a

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No