Solid Tumor MalignanciesEarly Phase 1NCT07923786
Clinical Study of 68Ga-labeled Novel EPHA2 Cyclic Peptides PET/CT for Imaging of Solid Tumors
A Early Phase 1 study testing ⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes PET/CT in people with Solid Tumor Malignancies, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study aims to develop novel ⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes for precise diagnosis and patient selection in EphA2-positive cancers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor Malignancies
- What is being tested?
- ⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 20 May 2028
- Phase
- Early Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ① Participants must voluntarily provide written informed consent and be able to complete the study in accordance with the protocol.
- ② Participants must be aged 18-75 years, inclusive, regardless of sex.
- ③ Participants must have a clinical diagnosis of cervical, ovarian, breast, lung, prostate, colorectal, or esophageal cancer, with biopsy findings serving as the diagnostic reference, and positive EphA2 expression confirmed by immunohistochemistry.
- ④ Participants must have at least one measurable lesion that can be accurately and reproducibly measured according to the modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
- ⑤ Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Hematological parameters, coagulation parameters, and hepatic and renal function must meet the following criteria, without blood transfusion, hematopoietic growth factor support, or hepatoprotective treatment to correct these parameters within 14 days before administration:
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- a) Hematology: White blood cell count (WBC) ≥2.5 × 10⁹/L or absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; platelet count (PLT) ≥100 × 10⁹/L; and hemoglobin ≥90 g/L.
- b) Coagulation: Prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 × the upper limit of normal (ULN). This criterion applies only to participants not receiving anticoagulation therapy; those receiving anticoagulation therapy must be on a stable anticoagulant dose.
- c) Hepatic function: Total bilirubin ≤1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; and alkaline phosphatase (ALP) ≤2.5 × ULN.
- d) Renal function: Urea ≤1.5 × ULN; serum creatinine ≤1.5 × ULN; and creatinine clearance ≥50 mL/min, calculated using the Cockcroft-Gault equation.
- Female participants of childbearing potential must have a negative pregnancy test. Female participants of childbearing potential and male participants of reproductive potential must agree to use effective contraception or abstain from sexual intercourse during the study.
Who cannot join
- ① Individuals who are unsuitable for or unable to complete PET/CT examinations for any reason, including but not limited to claustrophobia or fear of radiation.
- ② Individuals unable to tolerate intravenous administration, such as those with a history of fainting in response to needles or blood.
- ③ Individuals with known hypersensitivity to chimeric or humanized antibodies, fusion proteins, or any other excipients.
- ④ Individuals with any of the following conditions:
- a) Brain metastases, except asymptomatic primary or metastatic brain tumors that do not require treatment;
- b) Leptomeningeal carcinomatosis;
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- c) Poorly controlled diabetes mellitus;
- d) Myocardial infarction within 6 months before screening;
- e) Unstable angina;
- f) A history of uncontrolled arrhythmia or a current high risk of arrhythmia;
- g) Previous coronary artery bypass grafting;
- h) A cerebrovascular accident within 6 months before screening;
- i) Congestive heart failure (New York Heart Association functional class III-IV);
- j) Pulmonary embolism;
- k) Deep vein thrombosis;
- l) An infection requiring intravenous antibiotic treatment within 2 weeks before screening;
- m) A history of immunosuppressive therapy following organ transplantation.
- Individuals with a history of or a current primary central nervous system tumor.
- Individuals with acute or subacute intestinal obstruction or a history of inflammatory bowel disease.
- Individuals whose toxicities from previous anticancer treatment have not resolved to grade 0 or 1 according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, except for alopecia.
- ⑧ Individuals with an active autoimmune disease, a history of autoimmune disease requiring systemic corticosteroids and/or immunosuppressants, or a syndrome requiring systemic corticosteroid or immunosuppressive therapy.
- ⑨ Individuals with any psychiatric or cognitive condition (e.g., alcohol or drug abuse, dementia, or altered mental status), or any other condition that may impair study compliance, compromise their ability to understand the informed consent information, or, in the investigator's judgment, preclude study participation or interfere with the interpretation of study results.
- ⑩ Individuals who have received a live or live-attenuated vaccine within 28 days before administration of the investigational product or who plan to receive such a vaccine during the study.
- ⑪ Women who are pregnant, breastfeeding, or planning to become pregnant at screening.
- ⑫ Individuals who have participated in a clinical trial involving a radiopharmaceutical within 1 month before screening.
- ⑬ Individuals who have received medications or undergone clinical procedures within 1 month before screening that, in the investigator's judgment, may affect the uptake of [⁶⁸Ga]Ga-EP
- ⑭ Individuals with any other condition that, in the investigator's judgment, makes them unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: Clinical Study of 68Ga-labeled Novel EPHA2 Cyclic Peptides PET/CT for Imaging of Solid Tumors With High EPHA2 Expression
This study aims to develop novel ⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes for precise diagnosis and patient selection in EphA2-positive cancers.
- Conditions
- Solid Tumor Malignancies
- Being tested
- ⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes PET/CTDiagnostic test
Novel ⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes for precise diagnosis and patient selection in EphA2-positive cancers.
| Study group | Role | What they receive |
|---|---|---|
| ⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes PET/CT | Experimental | Not described Receives: Diagnostic Test: ⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Adverse effects after radiotracer injection and PET scan
Measured: From radiotracer injection to 24 hours post-injection.
Diagnostic efficacy
Detection rate and lesion number comparison on per-patient basis. Lesion number, SUVmax and TBR comparison on per-lesion basis.
Measured: Through study completion, an average of 6 months.
Secondary outcomes (1)
Dosimetry
Absorbed dose for target organs, Urinary bladder residence time, and whole-body effective dose were determined for 68Ga-EPHA2-Peptide
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start20 May 2026
- Primary completion20 Nov 2027 (estimated)
- Study completion20 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignanciesStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengming Deng, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923786
- Sponsor's protocol ID
- 2026-68Ga-EPHA2-peptides
- Status last verified
- May 2026
- First submitted
- 30 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of 68Ga-labeled Novel EPHA2 Cyclic Peptides PET/CT for Imaging of Solid Tumors With High EPHA2 Expression
- ClinicalTrials.gov ID
- NCT07923786
- Acronym / sponsor ID
- 2026-68Ga-EPHA2-peptides
- Conditions
- Solid Tumor Malignancies
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 20 Nov 2027 (estimated)
- Study completion
- 20 May 2028 (estimated)
- First posted
- 6 Nov 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.
This study aims to develop novel ⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes for precise diagnosis and patient selection in EphA2-positive cancers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes PET/CT | Experimental | Diagnostic Test: ⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes PET/CT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ① Participants must voluntarily provide written informed consent and be able to complete the study in accordance with the protocol.
- ② Participants must be aged 18-75 years, inclusive, regardless of sex.
- ③ Participants must have a clinical diagnosis of cervical, ovarian, breast, lung, prostate, colorectal, or esophageal cancer, with biopsy findings serving as the diagnostic reference, and positive EphA2 expression confirmed by immunohistochemistry.
- ④ Participants must have at least one measurable lesion that can be accurately and reproducibly measured according to the modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
- ⑤ Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
Key exclusion criteria (27 listed)
- ① Individuals who are unsuitable for or unable to complete PET/CT examinations for any reason, including but not limited to claustrophobia or fear of radiation.
- ② Individuals unable to tolerate intravenous administration, such as those with a history of fainting in response to needles or blood.
- ③ Individuals with known hypersensitivity to chimeric or humanized antibodies, fusion proteins, or any other excipients.
- a) Brain metastases, except asymptomatic primary or metastatic brain tumors that do not require treatment;
- b) Leptomeningeal carcinomatosis;
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-labeled EphA2-targeting cyclic peptide probes PET/CTNovel ⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes for precise diagnosis and patient selection in EphA2-positive cancers. | Diagnostic test | ⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes PET/CT |
Primary outcome
Safety
Time frame: From radiotracer injection to 24 hours post-injection.
Adverse effects after radiotracer injection and PET scan
Diagnostic efficacy
Time frame: Through study completion, an average of 6 months.
Detection rate and lesion number comparison on per-patient basis. Lesion number, SUVmax and TBR comparison on per-lesion basis.
1 secondary outcome
Dosimetry
Time frame: Through study completion, an average of 6 months
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 Nov 2026.
- Individual participant dataSharing planned: No
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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.
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 Early Phase 1 study testing ⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes PET/CT in people with Solid Tumor Malignancies, 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 11 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety (time frame: From radiotracer injection to 24 hours post-injection.). The study lists 2 primary outcomes in all. 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 Nov 2026.