Lung CancerNCT05156515
PD-L1 Targeting Nanobody Probe for PET Imaging of Solid Tumor
A study testing 68Ga-THP-APN09 in people with Lung Cancer and Melanoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Melanoma, PD-L1
- What is being tested?
- 68Ga-THP-APN09
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing cancer hospital
Beijing, Beijing Municipality, 100142
Hua Zhu, 010-88196495, zhuhuabch@pku.edu.cn
About this study
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
- Being tested
- 68Ga-THP-APN09
- Medical subject headings
- Lung Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-THP-APN09Diagnostic test
APN09, nanobody targeting PD-L1, labeled with PET radio-nuclide (68Ga) will be used as a molecular imaging tracer for PET/CT scan.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 68Ga-THP-APN09 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPR
In the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%.
Measured: After 2-4 cycles of immunotherapy (each cycle is 28 days)
Secondary outcomes (1)
PFS
progression free survival
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start9 Dec 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Zhu, Peking University Cancer Hospital & Institute
- Investigators
- Hua Zhu, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156515
- Sponsor's protocol ID
- 2021KT111
- Status last verified
- Mar 2023
- First submitted
- 8 Dec 2021
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39912938Ma 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.
PubMed 37555904
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-L1 Targeting Nanobody Probe for PET Imaging of Solid Tumor
- ClinicalTrials.gov ID
- NCT05156515
- Acronym / sponsor ID
- 2021KT111
- Conditions
- Lung Cancer, Melanoma, PD-L1, PET/CT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging cohort | Experimental | Diagnostic Test: 68Ga-THP-APN09All enrolled participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-THP-APN09 PET/CT scans. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-THP-APN09APN09, nanobody targeting PD-L1, labeled with PET radio-nuclide (68Ga) will be used as a molecular imaging tracer for PET/CT scan. | Diagnostic test | Imaging cohort |
Primary outcome
MPR
Time frame: After 2-4 cycles of immunotherapy (each cycle is 28 days)
In the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%.
1 secondary outcome
PFS
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Derived from this study: PubMed 39912938Zhou 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.
- Derived from this study: PubMed 37555904Ma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hua Zhu principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-THP-APN09 in people with Lung Cancer and Melanoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Zhu (010-88196495, zhuhuabch@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPR (time frame: After 2-4 cycles of immunotherapy (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05156515, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.