CClinicalTrials.gg
Status unknownNCT03638804Updated Dec 5, 2018

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

An interventional study of 89Zr-KN035 in Solid Tumor, Adult, sponsored by The First Affiliated Hospital of Soochow University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-12-05.

Sponsored by The First Affiliated Hospital of Soochow University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Solid Tumor, Adult

Browse trials for

Keywords

  • 89Zr
  • PD-L1
  • KN035
  • PET
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 10 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    89Zr-KN035 injection

    Diagnostic Test: 89Zr-KN035

Interventions

  • Diagnostic test89Zr-KN035

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

06

What researchers measure

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 6 months

Other outcomes

  1. Maximum serum concentration of 89Zr-KN035 (Cmax)

    Blood samples will be collected and assessed by timepoints.

    Time frame: 6 months

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

    Blood samples will be collected and assessed by timepoints.

    Time frame: 6 months

  3. Calculation of radiation dosimetry of 89Zr-KN035

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215006, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03638804
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborators
MITRO Biotech Co., Ltd.
Responsible party
Miao Liyan (Professor, The First Affiliated Hospital of Soochow University) — Principal investigator
First posted
Aug 20, 2018
Start date
Nov 12, 2018
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Dec 5, 2018

Study contacts

Hua Zhang
Contact
sdfyy8040@126.com
86 0512 6778 0040
Yicong Bian
Contact
bianyicong@126.com
86 0512 6778 0467
Liyan Miao, PhD
principal investigator · The First Affiliated Hospital of Soochow University
Jianan Huang, PhD
principal investigator · The First Affiliated Hospital of Soochow University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion