Research for the Molecular Imaging of the PD-L1 Targeting Tracer

To use the molecular probe PET radionuclide (Ga-68 or F-18) WL12 peptide to detect the expression of PD-L1 in the primary and metastatic lesions in patients with solid tumor; to detect the expression heterogeneity of PD-L1 in the lesion and inter-lesions; to observe the change of PD-L1 expression in the course of treatment. To provide an approach for screening patients with high expression of PD-L1, efficacy monitoring, drug resistance and early warning of recurrence and metastasis to achieve the Individualized antitumor treatment of targeted drugs.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer; Solid Tumor
• Intervention / Treatment: Other: 18F-WL12 PET or 68Ga-WL12 PET

Detailed Description

In many clinical trials, Anti-PD-1/PD-L1 mAbs have achieved great success than expected in a variety of refractory and recurrent tumor patients. The latest research shows that it is not all cancer patients would respond to Anti-PD-1/PD-L1 mAbs. At present, immunohistochemistry (IHC) is still a common method to screen patients that will benefit from this therapy by detecting the expression level of PD-1 and PD-L1. However, the results of IHC were not very exact because of limitations of IHC such as the heterogeneity of expression, the influence of host cell PD-L1 expression and the changes in the course of the disease. Moreover, the tumor tissue used in IHC must obtained through the invasive method. It is difficult to dynamically monitor the expression level of PD-1 / PD-L1 during the treatment. Immuno-PET molecular imaging By radiolabeling Anti-PD-1/PD-L1 mAbs with radionuclides can be used to noninvasive assessment of biodistribution of monoclonal antibodies and provide a new strategy for patient screening.

In this study, 18F-WL12 or 68Ga-WL12 PET / CT imaging will be performed in patients with solid tumors to access the potential of 18F-WL12 or 68Ga-WL12PET / CT to screen patients who can benefit from JS001 treatment.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Shunlian Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Aged >18 years old; ECoG 0 or 1;
• 2. Patients with solid tumors;
• 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
• 4. life expectancy >=12 weeks.

Exclusion Criteria:

• 1. Significant hepatic or renal dysfunction;
• 2. Is pregnant or ready to pregnant;
• 3. Cannot keep their states for half an hour;
• 4. Refusal to join the clinical study;
• 5. Suffering from claustrophobia or other mental diseases;
• 6. Any other situation that researchers think it is not suitable to participate in the experiment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imaging cohort; All study participants will be allocated to this arm (single-arm study).Study participants will undergo 18F-WL12 or 68Ga-WL12 PET/CT scans	Other: 18F-WL12 PET or 68Ga-WL12 PET; WL12, labeled with PET radio-nuclide ( Ga-68 or F-18)will be used as a molecular imaging tracer for PET/CT scanning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SUV	The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）on PET/CT	2 years

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2019KT116/2019KT62

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No