NCT02978196

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	Injection of 99mTc-NM-01	Patient is injected with micro-dose of 99mTc-NM-01
PROCEDURE	Injection of 68Ga-NM-01	Patient is injected with micro-dose of 68Ga-NM-01

Timeline

• Start date: 2018-02-15
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2016-11-30
• Last updated: 2024-05-17

Locations

1 site across 1 country: China