SarcomaNCT07847268
A First-in-Human Study of ¹⁷⁷Lu-HX02 in Sarcoma Patients
An observational study of Sarcoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This is a single-center, open-label clinical study to evaluate the safety, biodistribution, and dosimetry of ¹⁷⁷Lu-HX02 injection in patients with sarcoma. Approximately 6 to 10 subjects with sarcoma (preferably soft tissue sarcoma and Ewing's sarcoma), confirmed by histopathology, cytology, or clinical diagnosis, and… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcoma
- What is being tested?
- Safety, Biodistribution, and Dosimetry of ¹⁷⁷Lu-HX02 in Patients with Sarcoma
- Type of treatment
- Injection or infusion
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2025
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of male and female patients aged between 18 and 70 years, with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 and the ability to tolerate PET/MR and SPECT/CT examinations. Eligible patients must have a histopathologically, cytologically, or clinically confirmed diagnosis of sarcoma, with at least one measurable lesion according to RECIST 1.1 criteria. In addition, at least one measurable lesion must demonstrate an SUVmax ≥ 3.5 on [⁶⁸Ga]Ga-HX01 PET/MR imaging; final eligibility will be determined by the investigator and may be adjusted based on subsequent [¹⁷⁷Lu]Lu-HX02 SPECT/CT imaging findings.
Who may be able to join
- Participants must meet all of the following criteria:
- Voluntarily sign the written informed consent form prior to the initiation of any study-specific procedures;
- Age between 18 and 70 years, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, and able to tolerate PET/MR and SPECT/CT examinations;
- Histopathologically, cytologically, or clinically confirmed diagnosis of sarcoma, with at least one measurable lesion according to RECIST 1.1 criteria;
- At least one measurable lesion with SUVmax ≥ 3.5 on [68Ga]Ga-HX01 PET/MR imaging (eligibility to be determined by the investigator, and may be adjusted based on subsequent [177Lu]Lu-HX02 SPECT/CT imaging findings);
- Life expectancy ≥ 6 months;
- Female participants of childbearing potential must have a negative pregnancy test, and all participants (both male and female) must agree to use effective contraception during the study and for at least 3 months after administration.
Who cannot join
- Participants who meet any of the following criteria will be excluded from the study:
- Women who are pregnant or breastfeeding, or who plan to become pregnant during the study or within 3 months after administration [excluding those who have been postmenopausal for at least 1 year, or who have undergone surgical sterilization (e.g., bilateral tubal ligation without reversal, bilateral oophorectomy, or hysterectomy)]; or participants (both male and female) who plan to donate sperm or ova during the study or within 3 months after administration;
- Known or suspected allergy to the investigational product or any of its components, or severe allergic constitution;
- Have received any treatment within 6 months prior to screening that, in the investigator's judgment, may affect drug absorption, distribution, metabolism, or excretion;
- Positive syphilis or HIV test at screening;
- Significant hepatic or renal dysfunction, defined as: serum total bilirubin (TBIL) > 31.5 μmol/L; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 120 U/L, or > 200 U/L if the elevation is considered to be related to hepatic metastases from solid tumors; serum creatinine (Scr) > 150 μmol/L, or creatinine clearance < 60 mL/min (calculated by the Cockcroft-Gault formula);
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- Abnormal bone marrow function, defined as: absolute neutrophil count (ANC) < 1.5 × 109/L; hemoglobin < 10 g/dL; serum albumin < 2.8 g/dL (normal range: 3.5-5.5 g/dL); platelet count < 100 × 10⁹/L (normal range: 100-300 × 109/L); international normalized ratio (INR) > 1.5 (normal range: 0.8-1.3) in patients not receiving warfarin; prothrombin time (PT) > 2 × ULN (normal range: 11-15 seconds);
- Presence of active infection (e.g., acute bacterial infection, tuberculosis, active hepatitis B/C, active syphilis, etc.). Active hepatitis B is defined as: positive HBsAg or HBcAb test with HBV DNA titer > 2500 copies/mL or 500 IU/mL. Active hepatitis C is defined as: positive hepatitis C antibody with detectable HCV-RNA;
- Difficulty in urination or urinary incontinence due to any cause;
- Claustrophobia or any other condition that prevents the subject from undergoing PET/MR and SPECT/CT examinations;
- Psychiatric disorders, such as depressive symptoms, schizophrenia, delusions, hallucinations, or suicidal ideation;
- Severe cardiovascular disease, including but not limited to New York Heart Association (NYHA) class II-IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50% or below the lower limit of normal;
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-center, open-label clinical study to evaluate the safety, biodistribution, and dosimetry of ¹⁷⁷Lu-HX02 injection in patients with sarcoma. Approximately 6 to 10 subjects with sarcoma (preferably soft tissue sarcoma and Ewing's sarcoma), confirmed by histopathology, cytology, or clinical diagnosis, and with measurable lesions according to RECIST 1.1, are planned to be enrolled. The enrollment requires that at least one measurable lesion has an SUVmax ≥ 3.5 on ⁶⁸Ga-HX01 injection imaging. Eligible subjects who meet the inclusion/exclusion criteria will receive a single intravenous administration of ¹⁷⁷Lu-HX02 injection, followed by SPECT/CT imaging to assess the safety, biodistribution, and dosimetry of the drug. The study consists of two phases: a screening phase with ⁶⁸Ga-HX01 and a treatment/evaluation phase with ¹⁷⁷Lu-HX02.
- Conditions
- Sarcoma
- Being tested
- Safety, Biodistribution, and Dosimetry of ¹⁷⁷Lu-HX02 in Patients with Sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety, Biodistribution, and Dosimetry of ¹⁷⁷Lu-HX02 in Patients with SarcomaDiagnostic test
Subjects who meet the inclusion/exclusion criteria will receive an intravenous administration of ¹⁷⁷Lu-HX02 injection, followed by SPECT/CT imaging to evaluate the safety, biodistribution, and dosimetry of the drug.
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging Quantitative Assessment
After a single intravenous injection of ¹⁷⁷Lu-HX02, descriptive SUV statistics (mean, max, SD, min, max) will be obtained from ROIs in the liver, kidneys, and tumor lesions, and the target-to-background ratio (TBR, tumor/normal tissue) will be calculated.
Measured: 1, 3, 6, 24, and 72 hour post-injection
Safety Evaluation
All adverse events (AEs) will be monitored post-injection and graded per CTCAE v5.0 (grades 1-5). The primary measure is the number and incidence (%) of treatment-related adverse events (TRAEs).
Measured: From baseline through 6 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Mar 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoli Lan, PhD, Study director, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847268
- Sponsor's protocol ID
- XLan-20250018
- Status last verified
- Sep 2026
- First submitted
- 1 Jul 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study of ¹⁷⁷Lu-HX02 in Sarcoma Patients
- ClinicalTrials.gov ID
- NCT07847268
- Acronym / sponsor ID
- XLan-20250018
- Conditions
- Sarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 29 Sep 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 is a single-center, open-label clinical study to evaluate the safety, biodistribution, and dosimetry of ¹⁷⁷Lu-HX02 injection in patients with sarcoma. Approximately 6 to 10 subjects with sarcoma (preferably soft tissue sarcoma and Ewing's sarcoma), confirmed by histopathology, cytology, or clinical diagnosis, and with measurable lesions according to RECIST 1.1, are planned to be enrolled. The enrollment requires that at least one measurable lesion has an SUVmax ≥ 3.5 on ⁶⁸Ga-HX01 injection imaging. Eligible subjects who meet the inclusion/exclusion criteria will receive a single intravenous administration of ¹⁷⁷Lu-HX02 injection, followed by SPECT/CT imaging to assess the safety, biodistribution, and dosimetry of the drug. The study consists of two phases: a screening phase with ⁶⁸Ga-HX01 and a treatment/evaluation phase with ¹⁷⁷Lu-HX02.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of male and female patients aged between 18 and 70 years, with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 and the ability to tolerate PET/MR and SPECT/CT examinations. Eligible patients must have a histopathologically, cytologically, or clinically confirmed diagnosis of sarcoma, with at least one measurable lesion according to RECIST 1.1 criteria. In addition, at least one measurable lesion must demonstrate an SUVmax ≥ 3.5 on [⁶⁸Ga]Ga-HX01 PET/MR imaging; final eligibility will be determined by the investigator and may be adjusted based on subsequent [¹⁷⁷Lu]Lu-HX02 SPECT/CT imaging findings.
Key inclusion criteria (8 listed)
- Participants must meet all of the following criteria:
Key exclusion criteria (13 listed)
- Participants who meet any of the following criteria will be excluded from the study:
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 |
|---|---|---|
| Safety, Biodistribution, and Dosimetry of ¹⁷⁷Lu-HX02 in Patients with SarcomaSubjects who meet the inclusion/exclusion criteria will receive an intravenous administration of ¹⁷⁷Lu-HX02 injection, followed by SPECT/CT imaging to evaluate the safety, biodistribution, and dosimetry of the drug. | Diagnostic test | – |
Primary outcome
Imaging Quantitative Assessment
Time frame: 1, 3, 6, 24, and 72 hour post-injection
After a single intravenous injection of ¹⁷⁷Lu-HX02, descriptive SUV statistics (mean, max, SD, min, max) will be obtained from ROIs in the liver, kidneys, and tumor lesions, and the target-to-background ratio (TBR, tumor/normal tissue) will be calculated.
Safety Evaluation
Time frame: From baseline through 6 months post-injection
All adverse events (AEs) will be monitored post-injection and graded per CTCAE v5.0 (grades 1-5). The primary measure is the number and incidence (%) of treatment-related adverse events (TRAEs).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Enrolling by invitationPhase 1
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Soft Tissue Sarcoma, Non-small Cell Lung Cancer
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.
Xiaoli Lan, PhD study director
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 8 inclusion and 13 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: finished, as of the sponsor's last update on 29 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Imaging Quantitative Assessment (time frame: 1, 3, 6, 24, and 72 hour 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 29 Sep 2026.