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

Shanghai Jiao Tong University

Status and phase: Completed; Early Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Procedure: Injection of 99mTc-NM-01; Procedure: Injection of 68Ga-NM-01

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02978196

[2019]310

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Injection of 99mTc-NM-01

Experimental group

Description:

All patients with NSCLC who have undergone biopsy of primary tumour lesion will be administered 3-12 MBq/kg of 99mTc-NM-01 in a single injection.

Treatment:

Procedure: Injection of 99mTc-NM-01

Injection of 68Ga-NM-01

Experimental group

Description:

All patients with NSCLC who have undergone biopsy of primary tumour lesion will be administered 0.75- 4 MBq/kg of 68Ga-NM-01 in a single injection.

Treatment:

Procedure: Injection of 68Ga-NM-01