Solid Tumor, AdultNCT03638804
89Zr-KN035 PET Imaging in Patients With Advanced Solid Tumors
A study testing 89Zr-KN035 in people with Solid Tumor, Adult, run by The First Affiliated Hospital of Soochow University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- 89Zr-KN035
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2018to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Yicong Bian, 86 0512 6778 0467, bianyicong@126.com
About this study
Official title: 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.
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.
- Conditions
- Solid Tumor, Adult
- Being tested
- 89Zr-KN035
- Keywords
- 89Zr, PD-L1, KN035, PET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-KN035Diagnostic test
Single injection of 89Zr labeled KN035 in subjects to observe KN035 affinity in PD-L1 expressed Solid tumors by using PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-KN035 injection | Experimental | Not described Receives: Diagnostic Test: 89Zr-KN035 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start12 Nov 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- MITRO Biotech Co., Ltd.
- Responsible party
- Principal investigator, Miao Liyan, The First Affiliated Hospital of Soochow University
- Investigators
- Liyan Miao, PhD, Principal investigator, The First Affiliated Hospital of Soochow UniversityJianan Huang, PhD, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638804
- Sponsor's protocol ID
- AMS-2017-007-a
- Status last verified
- Dec 2018
- First submitted
- 23 Jul 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 89Zr-labeled KN035 PET Imaging in Patients With PD-L1positive Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03638804
- Acronym / sponsor ID
- AMS-2017-007-a
- Conditions
- Solid Tumor, Adult
- Keywords
- 89Zr, PD-L1, KN035, PET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- MITRO Biotech Co., Ltd.
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-KN035 injection | Experimental | Diagnostic Test: 89Zr-KN035 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (15 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-KN035Single injection of 89Zr labeled KN035 in subjects to observe KN035 affinity in PD-L1 expressed Solid tumors by using PET imaging. | Diagnostic test | 89Zr-KN035 injection |
Primary outcome
Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans
Time frame: 6 months
3 secondary outcomes
Number of adverse events as assessed by CTCAE v4.03
Time frame: 6 months
Number of changes in laboratory test results as accessed by CTCAE v4.03
Time frame: 6 months
Number of changes in vital signs as accessed by CTCAE v4.03
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liyan Miao, PhD principal investigator
The First Affiliated Hospital of Soochow University
Jianan Huang, PhD principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 89Zr-KN035 in people with Solid Tumor, Adult, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Zhang (86 0512 6778 0040, sdfyy8040@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.