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

Solid Tumor, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03638804
• Other study ID #: AMS-2017-007-a
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2018
• Est. completion date: December 2019

Study information

• Verified date: December 2018
• Source: The First Affiliated Hospital of Soochow University
• Contact: Hua Zhang
• Phone: 86 0512 6778 0040
• Email: sdfyy8040[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumor, Adult

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	MITRO Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximum serum concentration of 89Zr-KN035 (Cmax)	Blood samples will be collected and assessed by timepoints.	6 months
Other	Time to Maximum Concentration of 89Zr-KN035 (Tmax)	Blood samples will be collected and assessed by timepoints.	6 months
Other	Calculation of radiation dosimetry of 89Zr-KN035		6 months
Primary	Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans		6 months
Secondary	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
Secondary	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
Secondary	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