89Zr-labeled KN035 PET Imaging in Patients With PD-L1 Positive Solid Tumors

NCT04977128 | Unknown

• 1 other identifier: Wuxi 4 PDL1 202106
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (3)

• Biodistribution of 89Zr-KN035

  1 year

• Correlation 89Zr-KN035 uptake in tumor lesions and PD-L1 expression as determined by immunohistochemistry

  1 year

• Evaluation of immunotherapy efficacy

  1 year

Study Arms (1)

Experimental：89Zr-KN035 injection

EXPERIMENTAL

Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3mCi) labelled KN035 (89Zr- KN035)

Drug: 89Zr-KN035

Interventions

89Zr-KN035 DRUG

Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3mCi) labelled KN035 (89Zr- KN035)

Experimental：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 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.

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;
• 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;

Sponsors & Collaborators

• Wuxi No. 4 People's Hospital: lead

Study Sites (1)

Wuxi No. 4 People's Hospital

Wuxi, Jiangsu, 214062, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 26, 2021
• Study Start: March 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: July 26, 2021

Record last verified: 2021-03

Locations

CN (1)