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NCT Number: NCT02978196

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Shanghai General Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection of 99mTc-NM-01

Procedure

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

Injection of 68Ga-NM-01

Procedure

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

Primary outcomes

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

    Time frame: 1 year

    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.

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

    Time frame: 1 year

    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%.

Secondary outcomes

  1. PD-L1 expression levels

    Time frame: 1 year

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

  2. Adverse Drug Reaction Report

    Time frame: 7 days

    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.

  3. New tumor lesion detection

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • NanoMab Technology (UK) Limited

Registry information

Official study title

99mTc/68Ga Labeled Anti-PD-L1 sdAb in Assessment of Programmed Death Ligand-1 Expression in Non-small Cell Lung Cancer

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 30, 2016
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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