Solid Tumor, AdultNCT04977128
89Zr-labeled KN035 PET Imaging in Patients With PD-L1 Positive Solid Tumors
A study testing 89Zr-KN035 in people with Solid Tumor, Adult, run by Wuxi No. 4 People's Hospital at 1 site in China.
Trial summary
This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled KN035 (89Zr-KN035) PET Imaging in patients with PD-L1 positive 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
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Mar 2022
- 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 solid tumors confirmed by histopathology or cytology;
- At least one measurable solid lesion has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
- 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;
Show all 16Show fewer
- 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;
- Patients need to receive other anti-tumor treatments during the trial period；
- 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
Wuxi No. 4 People's Hospital
Wuxi, Jiangsu, 214062
Chunjing Yu, MD., 15312238622, ycj_wxd1978@163.com
About this study
Official title: Safety Study of 89Zr-labeled KN035 PET Imaging in Patients With PD-L1 Positive Solid Tumors
This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled KN035 (89Zr-KN035) PET Imaging in patients with PD-L1 positive solid tumors.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of 89Zr-KN035 and will undergo PET/CT scanning to determine uptake of 89Zr-KN035 in tumor lesions.
- Conditions
- Solid Tumor, Adult
- Being tested
- 89Zr-KN035
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-KN035Drug
Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3mCi) labelled KN035 (89Zr- KN035)
| Study group | Role | What they receive |
|---|---|---|
| Experimental：89Zr-KN035 injection | Experimental | Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3mCi) labelled KN035 (89Zr- KN035) Receives: Drug: 89Zr-KN035 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of 89Zr-KN035 in PD-L1 positive solid tumor patients
Safety will be assessed by evaluation of incidence of adverse events
Measured: 1 year
Secondary outcomes (3)
Biodistribution of 89Zr-KN035
The biodistribution of the tracer 89Zr-KN035 as assessed with 89Zr- KN035 PET scans.
Measured: 1 year
Correlation 89Zr-KN035 uptake in tumor lesions and PD-L1 expression as determined by immunohistochemistry
Correlation 89Zr-KN035 uptake in tumor lesions and PD-L1 expression as determined by immunohistochemistry
Measured: 1 year
Evaluation of immunotherapy efficacy
The correlation between the 89Zr-KN035 tumor uptake (Standardized uptake value SUV ) and response to therapy by performing 89Zr-KN035 scan before PD1 therapy， related to CT/MRI response according to RECIST1.1 criteria.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Mar 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (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.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuxi No. 4 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977128
- Sponsor's protocol ID
- Wuxi 4 PDL1 202106
- Status last verified
- Mar 2021
- First submitted
- 6 Jul 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of 89Zr-labeled KN035 PET Imaging in Patients With PD-L1 Positive Solid Tumors
- ClinicalTrials.gov ID
- NCT04977128
- Acronym / sponsor ID
- Wuxi 4 PDL1 202106
- Conditions
- Solid Tumor, Adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wuxi No. 4 People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 26 Jul 2021 (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 to evaluate the safety and biodistribution of 89Zr-labeled KN035 (89Zr-KN035) PET Imaging in patients with PD-L1 positive solid tumors.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of 89Zr-KN035 and will undergo PET/CT scanning to determine uptake of 89Zr-KN035 in tumor lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental：89Zr-KN035 injection | Experimental | Drug: 89Zr-KN035Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3mCi) labelled KN035 (89Zr- KN035) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients voluntarily signed informed consent;
- Age 18-75, male or female;
- Patients diagnosed with solid tumors confirmed by histopathology or cytology;
- At least one measurable solid lesion has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
- Patients with biopsy-proven PD-L1 positive;
Key exclusion criteria (16 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-KN035Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3mCi) labelled KN035 (89Zr- KN035) | Drug | Experimental：89Zr-KN035 injection |
Primary outcome
To evaluate the safety of 89Zr-KN035 in PD-L1 positive solid tumor patients
Time frame: 1 year
Safety will be assessed by evaluation of incidence of adverse events
3 secondary outcomes
Biodistribution of 89Zr-KN035
Time frame: 1 year
Correlation 89Zr-KN035 uptake in tumor lesions and PD-L1 expression as determined by immunohistochemistry
Time frame: 1 year
Evaluation of immunotherapy efficacy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Solid Tumor, Adult
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
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.
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 Wuxi No. 4 People's Hospital 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 7 inclusion and 16 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 26 Jul 2021. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of 89Zr-KN035 in PD-L1 positive solid tumor patients (time frame: 1 year). 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 26 Jul 2021.