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

NCT03638804 | Unknown

• 1 other identifier: AMS-2017-007-a
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor, Adult

Keywords

89Zr; PD-L1; KN035; PET

Outcome Measures

Primary Outcomes (1)

• Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans

  6 months

Secondary Outcomes (3)

• Number of adverse events as assessed by CTCAE v4.03

  6 months

• Number of changes in laboratory test results as accessed by CTCAE v4.03

  6 months

• Number of changes in vital signs as accessed by CTCAE v4.03

  6 months

Other Outcomes (3)

• Maximum serum concentration of 89Zr-KN035 (Cmax)

  6 months

• Time to Maximum Concentration of 89Zr-KN035 (Tmax)

  6 months

• Calculation of radiation dosimetry of 89Zr-KN035

  6 months

Study Arms (1)

89Zr-KN035 injection

EXPERIMENTAL

Diagnostic Test: 89Zr-KN035

Interventions

89Zr-KN035 DIAGNOSTIC_TEST

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

89Zr-KN035 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Patients with systemic or locally severe infections (CTCAE ≥ 2);
• Patients with allergies or allergies to any component of the imaging agent or antibody;
• Patients who cannot undergo PET/CT imaging;
• Intolerance of intravenous administration, as well as difficulties in venous blood collection (If having the medical history of fainting during acupuncture, and blood phobia);
• Symptomatic congestive heart failure (NYHA class II-IV) or symptomatic or poorly controlled arrhythmia;
• Patients have significant QT/QTC interval prolongation during the screening period;
• Received anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, biological therapy) within 4 weeks prior to first dose;
• Patents have not recovered to CTCAE grade 0 or 1 from the adverse events due to cancer therapeutics administered;
• Previously received CD137 agonist or immune checkpoint blocking therapy;
• Patients with diabetes who have a fasting blood glucose greater than 10 mmol/L;
• HIV antibody positive, active hepatitis B/C, and TB positive;
• 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);
• Patients with symptomatic ascites, pleural effusion, or hydropericardium;
• Pregnant or lactating women, or planning to become pregnant or have children during this trial.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• MITRO Biotech Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Study Officials

• Liyan Miao, PhD

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

• Jianan Huang, PhD

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Zhang

CONTACT

86 0512 6778 0040; sdfyy8040@126.com

Yicong Bian

CONTACT

86 0512 6778 0467; bianyicong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 20, 2018
• Study Start: November 12, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

CN (1)