Soft Tissue SarcomaPhase 2NCT07920835
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
A Phase 2 study testing 68Ga-HX01 Injection Solution in people with Soft Tissue Sarcoma, run by Hexin (Suzhou) Pharmaceutical Technology Co., Ltd at 1 site in China.
Trial summary
soft tissue sarcoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- 68Ga-HX01 Injection Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Phase 2
- 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
- Agree to comply with all the requirements and procedures of the clinical trial and voluntarily sign the informed consent form;
- Male or female patients aged 18 years or older at the time of signing the informed consent form;
- Diagnosed with soft tissue sarcoma by histopathology or cytology, and failed or were intolerant to at least one line of standard treatment, or had no standard treatment available, or refused to receive standard treatment;
- Have at least one measurable lesion (according to RECIST V1.1 standards, a measurable lesion is defined as: a non-lymph node lesion with the longest diameter ≥ 10mm or a lymph node lesion with the short diameter ≥ 15mm measured by CT or MRI);
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1;
- Female or male participants with reproductive capacity must not have any plans for pregnancy, egg donation or sperm donation from the date of signing the informed consent form until 3 months after the administration of the trial drug, and must agree to take effective contraception (including one or more non-drug contraceptive measures) or safety measures during this period.
Who cannot join
- Pregnant or lactating women, or women of childbearing age who tested positive for pregnancy during the screening period;
- Those known or suspected to be allergic to the test drug or any of its components;
- Those who had received other investigational drugs at the time of enrollment, or were within 5 half-lives of the drug at the time of enrollment or within 4 weeks after the last administration, whichever is shorter; those who planned to participate in any clinical trial of drugs or devices during the trial period within 4 weeks before the administration of the test drug or within 3 half-lives after the last administration;
- Those who had received anti-angiogenic drugs within 4 weeks before the administration of the test drug or 3 half-lives (whichever is longer);
- Those who had previously used radioactive nuclides and the interval from the administration of this trial drug to the current time was less than 10 physical half-lives;
- Those who had undergone major surgery within 4 weeks before the administration of the test drug, or had undergone diagnostic surgery or invasive intervention within 7 days before the administration, or planned to have surgery and other invasive interventions within 2 days after the administration of the test drug;
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- Those who cannot accept or tolerate blood sample collection and intravenous administration (if they have a history of fainting or hemophilia);
- Those with positive results for human immunodeficiency virus antibody, active syphilis (defined as positive syphilis antibody test and positive RPR test), or active hepatitis B (defined as hepatitis B virus [HBV] DNA ≥ 2000 IU/mL) or hepatitis C (defined as positive HCV RNA test);
- Those with significantly abnormal liver and kidney functions: serum total bilirubin (TBIL) > 1.5 × ULN (upper limit of normal value), or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 × ULN, or serum creatinine > 1.5 × ULN;
- Those who had suffered from other malignant tumors within 2 years, except for skin basal cell carcinoma, skin non-metastatic superficial squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ;
- Those who had active infections requiring systemic anti-infective treatment at the time of screening;
- Those who cannot lie still and remain quiet for about 60 minutes in the PET examination cabin, or have claustrophobia or other conditions that prevent them from cooperating with the PET examination;
- Any severe diseases that are uncontrollable, such as severe cardiac dysfunction (such as unstable angina pectoris, myocardial infarction, heart failure, etc.), patients with large pleural effusion, patients with mental disorders, etc.;
- Other situations that the investigator deems as unsuitable for participating in this trial.
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, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Xiaoli Lan archiater, 13886193262, hzslxl@163.com
About this study
Official title: A Prospective, Single-arm, Multicenter Phase II Clinical Trial Evaluating the Tumor Uptake Characteristics, Biological Distribution and Safety of 68Ga-HX01 Injection for PET/CT Imaging of Different Types of Soft Tissue Sarcomas
soft tissue sarcoma
- Conditions
- Soft Tissue Sarcoma
- Being tested
- 68Ga-HX01 Injection Solution
- Keywords
- Evaluation of the tumor uptake characteristics, biological distribution and safety
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-HX01 Injection SolutionDrug
Patients confirmed to have soft tissue sarcoma through histological/cytological examination and who have failed at least one line of standard treatment. All trial participants were required to receive a single intravenous injection of 68Ga-HX01 solution on the first day of the trial, and a PET/CT scan was to be conducted 40 minutes ± 5 minutes after the injection began.
| Study group | Role | What they receive |
|---|---|---|
| single ARM | Experimental | All trial participants were required to receive 68Ga-HX01 injection intravenously once on the first day of the trial. Receives: Drug: 68Ga-HX01 Injection Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The max uptake of each lesion
SUVmax was automatically calculated to quantify 68Ga-HX01 uptake in the lesions.
Measured: At40±5minutes after 68Ga-HX01 injection.
The mean uptake of each lesion
SUVmean was automatically calculated to quantify 68Ga-HX01 uptake in the lesions.
Measured: At40±5minutes after 68Ga-HX01 injection.
biochores
Measure the biological distribution of 68Ga-HX01 injection in the body using a mapping software
Measured: 12 weeks
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 start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hexin (Suzhou) Pharmaceutical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920835
- Sponsor's protocol ID
- HX2025009
- Status last verified
- Nov 2026
- First submitted
- 13 Oct 2026
- Last updated
- 6 Nov 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 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multicenter Phase II Clinical Trial Evaluating the Tumor Uptake Characteristics, Biological Distribution and Safety of 68Ga-HX01 Injection for PET/CT Imaging of Different Types of Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT07920835
- Acronym / sponsor ID
- HX2025009
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Evaluation of the tumor uptake characteristics, biological distribution and safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hexin (Suzhou) Pharmaceutical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (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.
soft tissue sarcoma
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single ARM | Experimental | Drug: 68Ga-HX01 Injection SolutionAll trial participants were required to receive 68Ga-HX01 injection intravenously once on the first day of the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Agree to comply with all the requirements and procedures of the clinical trial and voluntarily sign the informed consent form;
- Male or female patients aged 18 years or older at the time of signing the informed consent form;
- Diagnosed with soft tissue sarcoma by histopathology or cytology, and failed or were intolerant to at least one line of standard treatment, or had no standard treatment available, or refused to receive standard treatment;
- Have at least one measurable lesion (according to RECIST V1.1 standards, a measurable lesion is defined as: a non-lymph node lesion with the longest diameter ≥ 10mm or a lymph node lesion with the short diameter ≥ 15mm measured by CT or MRI);
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1;
Key exclusion criteria (14 listed)
- Pregnant or lactating women, or women of childbearing age who tested positive for pregnancy during the screening period;
- Those known or suspected to be allergic to the test drug or any of its components;
- Those who had received other investigational drugs at the time of enrollment, or were within 5 half-lives of the drug at the time of enrollment or within 4 weeks after the last administration, whichever is shorter; those who planned to participate in any clinical trial of drugs or devices during the trial period within 4 weeks before the administration of the test drug or within 3 half-lives after the last administration;
- Those who had received anti-angiogenic drugs within 4 weeks before the administration of the test drug or 3 half-lives (whichever is longer);
- Those who had previously used radioactive nuclides and the interval from the administration of this trial drug to the current time was less than 10 physical half-lives;
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-HX01 Injection SolutionPatients confirmed to have soft tissue sarcoma through histological/cytological examination and who have failed at least one line of standard treatment. All trial participants were required to receive a single intravenous injection of 68Ga-HX01 solution on the first day of the trial, and a PET/CT scan was to be conducted 40 minutes ± 5 minutes after the injection began. | Drug | single ARM |
Primary outcome
The max uptake of each lesion
Time frame: At40±5minutes after 68Ga-HX01 injection.
SUVmax was automatically calculated to quantify 68Ga-HX01 uptake in the lesions.
The mean uptake of each lesion
Time frame: At40±5minutes after 68Ga-HX01 injection.
SUVmean was automatically calculated to quantify 68Ga-HX01 uptake in the lesions.
biochores
Time frame: 12 weeks
Measure the biological distribution of 68Ga-HX01 injection in the body using a mapping software
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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-HX01 Injection Solution in people with Soft Tissue Sarcoma, run by Hexin (Suzhou) Pharmaceutical Technology Co., Ltd 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 6 inclusion and 14 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: looking for participants now, 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Lan Xiaoli archiater (13886193262, hzslxl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The max uptake of each lesion (time frame: At40±5minutes after 68Ga-HX01 injection.). The study lists 3 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.