Clinical trial · Interventional
PD-L1 Targeting Nanobody Probe for PET Imaging of Solid Tumor
NCT05156515CI-TRIAL-00065129unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| PD-L1 | — | UNRESOLVED | — |
| PET/CT | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-THP-APN09 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imaging cohort
- description
- All enrolled participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-THP-APN09 PET/CT scans.
- interventionNames
- Diagnostic Test: 68Ga-THP-APN09
Primary outcomes (1)
- measure
- MPR
- timeFrame
- After 2-4 cycles of immunotherapy (each cycle is 28 days)
- description
- In the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%.
Secondary outcomes (1)
- measure
- PFS
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDZhou 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
- DERIVEDMa 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