PD-L1 Targeting Nanobody Probe for PET Imaging of Solid Tumor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-09

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to construct a noninvasive approach using 68Ga-THP-APN09 PET/CT to detect the PD-L1 expression of tumor lesion in patients with lung cancer, melanoma and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PD-L2 Targeting Nanobody Radiotracer for PET Imaging of Solid Tumor

NCT05803746

Lung Cancer Colorectal Cancer

UNKNOWN NA

PD-L1 Specific 68Ga-THP-PD-L1-3 Probe for PET Imaging in Solid Tumors

NCT06383598

Solid Tumor

RECRUITING NA

PD-L1 Targeting Molecular Imaging of Solid Tumors

NCT04629326

Gastrointestinal Tumors

RECRUITING NA

[68Ga]Ga-NOTA-RW102 PET Imaging in the Diagnosis of PD-L1-expressing Lung Cancer

NCT06165874

Non-small Cell Lung Cancer

RECRUITING NA

Radiolabelled Nectin-4 Targeted LMW Probe PET/CT in Patients With Lung Lesions

NCT06648317

Lung Cancer, Non-Small Cell Lung Infection

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer Melanoma PD-L1 PET/CT

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Imaging cohort

All enrolled participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-THP-APN09 PET/CT scans.

Group Type EXPERIMENTAL

68Ga-THP-APN09

Intervention Type DIAGNOSTIC_TEST

APN09, nanobody targeting PD-L1, labeled with PET radio-nuclide (68Ga) will be used as a molecular imaging tracer for PET/CT scan.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

68Ga-THP-APN09

APN09, nanobody targeting PD-L1, labeled with PET radio-nuclide (68Ga) will be used as a molecular imaging tracer for PET/CT scan.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Aged 18-75, male and female, with ECOG score of 0 or 1;
2. Subjects with head and neck tumors, lung cancer, esophageal cancer, breast cancer, ovarian cancer, cholangiocarcinoma, colorectal cancer, gastric cancer, pancreatic cancer, melanoma, bone or soft tissue sarcoma, solid tumors or suspected tumor subjects who intend to undergo pathological tissue biopsy or receive tumor surgical treatment in the near future (within 2 months);
3. The expected survival was more than 26 weeks;
4. Blood routine test, liver and kidney function meet the following standards: blood routine: WBC \>= 4.0 x 10\^9/L or neutrophil \>= 1.5 x 10\^9/:, PLT \>= 100 x 10\^9 / L, Hb \>= 90g / L; Pt or APTT \<= 1.5 upper limit of normal value; liver and kidney function: total bilirubin \<= 1.5 x ULT (upper limit of normal value), ALT / AST \<= 2.5 upper limit of normal value or \<= 5 x ULT (subject with liver metastasis), ALP \<= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP \<= 4.5 upper limit of normal value); BUN \<= 1.5 x ULT, SCR \<= 1.5 x ULT;
5. According to RECIST1.1, there was at least one measurable target lesion;
6. Women must take effective contraceptive measures during the study period and within 6 months after the end of the study; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period;
7. Understand and sign informed consent voluntarily with good compliance.

Exclusion Criteria

1. The function of liver and kidney was seriously abnormal;
2. Preparation for pregnant, pregnant and lactating women;
3. Inability to lie flat for half an hour;
4. Suffering from claustrophobia or other mental disorders; 5) Other researchers considered it unsuitable to participate in the trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No