Solid Tumors With High Expression of Nectin4NCT07319130
Clinical Study of 68Ga-labeled Novel Nectin-4 Bicyclic Peptide PET/CT for Imaging of Solid Tumors With High Nectin-4 Expression
A study testing Immunohistochemistry in people with Solid Tumors With High Expression of Nectin4, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Tumors are one of the major diseases threatening human health, among which solid tumors account for a considerable proportion. Nectin-4, as an important cell adhesion molecule, shows a highly expressed state in various solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors With High Expression of Nectin4
- What is being tested?
- Immunohistochemistry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age: 18 to 75 years old (including the boundary value), gender not limited. 2. Solid tumors (such as urothelial carcinoma, breast cancer, lung cancer, etc.) that have been pathologically diagnosed with high expression of Nectin-4 within one month before imaging.
- 3. At least one evaluable tumor lesion (primary or metastatic) exists. 4. Voluntarily sign the informed consent form and be able to cooperate with the research process.
- 5.ECOG score: 0 to 2 points, expected survival period: ≥6 months.
Who cannot join
- 1. Combined with other active malignant tumors (excluding non-melanoma skin cancer or carcinoma in situ).
- 2. Severe heart, liver and kidney insufficiency (such as ALT/AST >3 times ULN, creatinine clearance rate <30 mL/min).
- 3. Uncontrolled systemic infections or immune system diseases. 4. Pregnant or lactating women, or patients of childbearing age who have not taken effective contraceptive measures.
- 5. Previously received Nectin-4 targeted therapy (such as Enfortumab vedotin).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Tumors are one of the major diseases threatening human health, among which solid tumors account for a considerable proportion. Nectin-4, as an important cell adhesion molecule, shows a highly expressed state in various solid tumors. In triple-negative breast cancer, the high expression rate of Nectin-4 can reach more than 50%, and it is closely associated with tumor invasion, metastasis and poor prognosis. Relevant studies have shown that the five-year survival rate of triple-negative breast cancer patients with high expression of Nectin-4 is significantly lower than that of patients with low expression. In urothelial carcinoma, the positive expression rate of Nectin-4 is also relatively high, reaching 40%-60%, and it is a highly potential target for tumor treatment and diagnosis. Its abnormal expression in solid tumors has opened up a new direction for the early diagnosis and targeted therapy of tumors. However, at present, the precise diagnosis and effective treatment of solid tumors with high expression of Nectin-4 still face many challenges. There is an urgent need for new technologies and methods to improve the diagnosis and treatment level in order to improve the prognosis of patients. Therefore, this study aims to develop a method targeting the Nectin4 bicyclic peptide to achieve non-invasive visualization of Nectin4 expression in tumors. This approach may also contribute to the formulation and optimization of clinical treatment strategies
- Being tested
- Immunohistochemistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunohistochemistryDiagnostic test
Nectin4 Immunohistochemistry testing
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-Nectin4 bicyclic peptide PET/CT imaging | Experimental | Not described Receives: Diagnostic Test: Immunohistochemistry |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET/CT imaging SuV value
Measured: 0-45 minutes, 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start3 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors With High Expression of Nectin4Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319130
- Sponsor's protocol ID
- 2025-68Ga-Nectin-4-peptide 02
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of 68Ga-labeled Novel Nectin-4 Bicyclic Peptide PET/CT for Imaging of Solid Tumors With High Nectin-4 Expression
- ClinicalTrials.gov ID
- NCT07319130
- Acronym / sponsor ID
- 2025-68Ga-Nectin-4-peptide 02
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jan 2026 (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.
Tumors are one of the major diseases threatening human health, among which solid tumors account for a considerable proportion. Nectin-4, as an important cell adhesion molecule, shows a highly expressed state in various solid tumors. In triple-negative breast cancer, the high expression rate of Nectin-4 can reach more than 50%, and it is closely associated with tumor invasion, metastasis and poor prognosis. Relevant studies have shown that the five-year survival rate of triple-negative breast cancer patients with high expression of Nectin-4 is significantly lower than that of patients with low expression. In urothelial carcinoma, the positive expression rate of Nectin-4 is also relatively high, reaching 40%-60%, and it is a highly potential target for tumor treatment and diagnosis. Its abnormal expression in solid tumors has opened up a new direction for the early diagnosis and targeted therapy of tumors. However, at present, the precise diagnosis and effective treatment of solid tumors with high expression of Nectin-4 still face many challenges. There is an urgent need for new technologies and methods to improve the diagnosis and treatment level in order to improve the prognosis of patients. Therefore, this study aims to develop a method targeting the Nectin4 bicyclic peptide to achieve non-invasive visualization of Nectin4 expression in tumors. This approach may also contribute to the formulation and optimization of clinical treatment strategies
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-Nectin4 bicyclic peptide PET/CT imaging | Experimental | Diagnostic Test: Immunohistochemistry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Age: 18 to 75 years old (including the boundary value), gender not limited. 2. Solid tumors (such as urothelial carcinoma, breast cancer, lung cancer, etc.) that have been pathologically diagnosed with high expression of Nectin-4 within one month before imaging.
- 3. At least one evaluable tumor lesion (primary or metastatic) exists. 4. Voluntarily sign the informed consent form and be able to cooperate with the research process.
- 5.ECOG score: 0 to 2 points, expected survival period: ≥6 months.
Key exclusion criteria (4 listed)
- 1. Combined with other active malignant tumors (excluding non-melanoma skin cancer or carcinoma in situ).
- 2. Severe heart, liver and kidney insufficiency (such as ALT/AST >3 times ULN, creatinine clearance rate <30 mL/min).
- 3. Uncontrolled systemic infections or immune system diseases. 4. Pregnant or lactating women, or patients of childbearing age who have not taken effective contraceptive measures.
- 5. Previously received Nectin-4 targeted therapy (such as Enfortumab vedotin).
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 |
|---|---|---|
| ImmunohistochemistryNectin4 Immunohistochemistry testing | Diagnostic test | 68Ga-Nectin4 bicyclic peptide PET/CT imaging |
Primary outcome
PET/CT imaging SuV value
Time frame: 0-45 minutes, 60 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunohistochemistry in people with Solid Tumors With High Expression of Nectin4, run by The First Affiliated Hospital of Soochow University 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 3 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: enrolling by invitation, as of the sponsor's last update on 6 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET/CT imaging SuV value (time frame: 0-45 minutes, 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.