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

NCT05156515 | Unknown

• 1 other identifier: 2021KT111
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Melanoma; PD-L1; PET/CT

Outcome Measures

Primary Outcomes (1)

• MPR

  In the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%.

  After 2-4 cycles of immunotherapy (each cycle is 28 days)

Secondary Outcomes (1)

• PFS

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

Study Arms (1)

Imaging cohort

EXPERIMENTAL

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

Diagnostic Test: 68Ga-THP-APN09

Interventions

68Ga-THP-APN09 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.

Imaging cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75, male and female, with ECOG score of 0 or 1;
• 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);
• The expected survival was more than 26 weeks;
• 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;
• According to RECIST1.1, there was at least one measurable target lesion;
• 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;
• Understand and sign informed consent voluntarily with good compliance.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing cancer hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (2)

• Zhou X, Yan S, Ma X, Zhu H, Liu B, Yang X, Jia B, Yang Z, Wu N, Li N. Efficacy of radiolabelled PD-L1-targeted nanobody in predicting and evaluating the combined immunotherapy and chemotherapy for resectable non-small cell lung cancer. Eur J Nucl Med Mol Imaging. 2025 Jun;52(7):2343-2354. doi: 10.1007/s00259-025-07115-3. Epub 2025 Feb 6.

  PMID: 39912938 DERIVED

• Ma X, Zhou X, Hu B, Li X, Yao M, Li L, Qin X, Li D, Yao Y, Hou X, Liu S, Chen Y, Wang Z, Zhou W, Li N, Zhu H, Jia B, Yang Z. Preclinical evaluation and pilot clinical study of [68Ga]Ga-THP-APN09, a novel PD-L1 targeted nanobody radiotracer for rapid one-step radiolabeling and PET imaging. Eur J Nucl Med Mol Imaging. 2023 Nov;50(13):3838-3850. doi: 10.1007/s00259-023-06373-3. Epub 2023 Aug 9.

  PMID: 37555904 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hua Zhu

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Zhu

CONTACT

010-88196495; zhuhuabch@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 14, 2021
• Study Start: December 9, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

CN (1)