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

NCT ID: NCT03638804

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-12
• Study Completion Date: 2019-12-31

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.

Conditions

Solid Tumor, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

89Zr-KN035 injection

Group Type: EXPERIMENTAL

89Zr-KN035

Intervention Type: DIAGNOSTIC_TEST

Single injection of 89Zr labeled KN035 in subjects to observe KN035 affinity in PD-L1 expressed Solid tumors by using PET imaging.

Interventions

89Zr-KN035

Single injection of 89Zr labeled KN035 in subjects to observe KN035 affinity in PD-L1 expressed Solid tumors by using PET imaging.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MITRO Biotech Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Miao Liyan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liyan Miao, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Jianan Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hua Zhang

Role: CONTACT

sdfyy8040@126.com

86 0512 6778 0040

Yicong Bian

Role: CONTACT

bianyicong@126.com

86 0512 6778 0467

Facility Contacts

Yicong Bian

Role: primary

bianyicong@126.com

86 0512 6778 0467

Other Identifiers

AMS-2017-007-a

Identifier Type: -

Identifier Source: org_study_id