99mTc/68Ga Labeled Anti-PD-L1 sdAb in Assessment of PD-L1 Expression in NSCLC
NCT02978196 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2024-05-17
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
Interventions
- 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
Sponsors & Collaborators
-
NanoMab Technology (UK) Limited
collaborator INDUSTRY -
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-15
- Primary Completion
- 2022-12-31
- Completion
- 2022-12-31
Countries
- China
Study Locations
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