99mTc/68Ga Labeled Anti-PD-L1 sdAb in Assessment of PD-L1 Expression in NSCLC

Early Phase 1CompletedNCT02978196

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine34 enrolled

Overview

To evaluate the safety, dosimetry and efficacy of 99mTc/68Ga labeled anti-PD-L1 single domian antibody (sdAb) (Product Code Name: 99mTc-NM-01 and 68Ga-NM-01) in the diagnostic imaging PD-L1 expression in Non-Small Cell Lung Cancer (NSCLC) and compare it with the existing gold standard "biopsy PD-L1 detection". It is also to establish a new clinical method of non-invasive PD-L1 expression detection in NSCLC using 99mTc/68Ga labeled anti-PD-L1 sdAb.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer

Interventions

Injection of 99mTc-NM-01PROCEDURE

Patient is injected with micro-dose of 99mTc-NM-01

Injection of 68Ga-NM-01PROCEDURE

Patient is injected with micro-dose of 68Ga-NM-01

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed * Male or female, aged 18-75 years old * Previous diagnosis of non-small cell carcinoma, confirmed with pathology tests * AST, ALT, BUN, Cr not more than double the normal values * Patients with no current history of hepatitis A, hepatitis B, AIDS, tuberculosis and other infectious diseases Exclusion Criteria: * Severe infection * Unable to provide biopsy sample for testing PD-L1 expression level * Patients with pacemakers * Pregnant and lactating women * Investigators professional decision that the subject should not participate in this clinical study

Locations (1)

Shanghai General Hospital

Shanghai, China

Outcomes

Primary Outcomes

Visual Assessment of PD-L1 expression in NSCLC using 99mTc-NM-01 SPECT/CT and 68Ga-NM-01 PET/CT Scan

Visual analysis will be carried out by 4 experienced nuclear medicine physicians to observe the uptake of 99mTc-NM-01 and 68Ga-NM-01 in lung lesions. A 4 point system will be used to interpret the scans for abnormalities. It is categorised as such: score 0, no abnormal increased uptake; score 1, low increased uptake; score 2, moderate increased uptake; score 3, high increased uptake. The lesion will be considered positive for malignancy if the score is 2 or higher.

Time frame: 1 year

Semiquantitative Assessment of Lung Lesions in 99mTc-NM-01 SPECT/CT and 68Ga-NM-01 PET Scan

Patients in the 99mTc-NM-01 group will be administered 3-12 MBq/kg of 99mTc-NM-01 and patients in the 68Ga-NM-01 group will be administered 0.75-4 MBq/kg of 68Ga-NM-01. The semiquantitative analysis of the region of interest (ROI) will be performed in lung lesions. Higher level of PD-L1 expression (Tumor proportion score, TPS), higher ROI in tumor. No expression TPS \< 1%; Low expression TPS 1 - 49%; High expression TPS ≥ 50%.

Time frame: 1 year

Secondary Outcomes

PD-L1 expression levels

Patients biopsy sample will be tested to confirm the levels of PD-L1 expression using Human PD-L1 ELISA Kit.

Time frame: 1 year

Adverse Drug Reaction Report

Monitor adverse events within 7 days after the injection and scanning to establish the safety of 99mTc-NM-01 and 68Ga-NM-01 in patients.

Time frame: 7 days

New tumor lesion detection

99mTc-NM-01 SPECT/CT and 68Ga-NM-01 PET/CT may detect new tumor areas, which can be further proven by biopsy method in order to rule out any false positive results.

Time frame: 1 year

Data from ClinicalTrials.gov

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