Clinical Trial · NCT07847268

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

Overview

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.

Sponsor

Norwegian University of Science and Technology

Contacts

Xiaoli Lan, PhD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT07847268

Drug / Compound

HX01

Isotope(s):

Target(s):

Ligand Class: Peptides

HX02

Isotope(s):

Target(s):

Ligand Class: Peptides

Eligibility

Inclusion

Histopathologically, cytologically, or clinically confirmed diagnosis of sarcoma, with at least one measurable lesion according to RECIST 1.1 criteria;
Participants must meet all of the following criteria:
Life expectancy ≥ 6 months;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, and able to tolerate PET/MR and SPECT/CT examinations;
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.
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);

Exclusion

Claustrophobia or any other condition that prevents the subject from undergoing PET/MR and SPECT/CT examinations;
Have received any treatment within 6 months prior to screening that, in the investigator's judgment, may affect drug absorption, distribution, metabolism, or excretion;
Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in this study.
Known or suspected allergy to the investigational product or any of its components, or severe allergic constitution;
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;
Participants who meet any of the following criteria will be excluded from the study:
Psychiatric disorders, such as depressive symptoms, schizophrenia, delusions, hallucinations, or suicidal ideation;
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;
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);
Difficulty in urination or urinary incontinence due to any cause;
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);
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;
Positive syphilis or HIV test at screening;