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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05156515
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Peking University Cancer Hospital & Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Hua Zhu
Principal Investigator Affiliation	Peking University Cancer Hospital & Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lung Cancer, Melanoma, PD-L1, PET/CT

Arms & Interventions

Arms

Experimental: Imaging cohort

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

Interventions

Diagnostic Test: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing cancer hospital, Beijing, Beijing, China

Status

Recruiting

Address

Beijing cancer hospital

Beijing, Beijing, 100142

Site Contact

Hua Zhu

[email protected]

010-88196495

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