A First-in-Human Study of ¹⁷⁷Lu-HX02 in Sarcoma Patients

NCT07847268 | Completed

• 1 other identifier: XLan-20250018
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  From baseline through 6 months post-injection

Interventions

Safety, Biodistribution, and Dosimetry of ¹⁷⁷Lu-HX02 in Patients with Sarcoma DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Xiaoli Lan, PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: September 29, 2026
• Study Start: March 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

CN (1)