TheranosticTrials.org

Clinical Trial · NCT07920822

Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors

Overview

This study is a single-center, open-label, phase I dose-escalation clinical trial, aiming to evaluate the safety and tolerability, radiation dosimetry and pharmacokinetic characteristics, as well as the preliminary efficacy of 177Lu-HX02 injection in patients with advanced malignant solid tumors.

Sponsor

Hexin (Suzhou) Pharmaceutical Technology Co., Ltd

Phase

Phase 1

ClinicalTrials.gov

NCT07920822

Eligibility

Inclusion

  • Liver function Total bilirubin ≤ 1.5×ULN (for liver metastasis subjects, total bilirubin ≤ 2×ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3×ULN (for liver metastasis subjects, ALT and AST \< 5×ULN); Albumin \> 30 g/L;
  • ECOG score 0 to 1, able to tolerate PET/CT and SPECT/CT examinations;
  • Previous standard treatment failed;
  • The functional level of organs must meet the following requirements:
  • Expected survival period ≥ 6 months;
  • Toxicity of previous anti-tumor treatment (such as previous chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) has recovered to ≤ grade 1 level (except for hair loss);
  • Bone marrow Neutrophil count ≥ 1.5×109/L and white blood cell count ≥ 2.5×109/L; Platelets ≥ 100×109/L; Hemoglobin ≥ 90 g/L;
  • Coagulation function International normalized ratio (INR) ≤ 2.0, activated partial thromboplastin time (APTT) ≤ 1.5×ULN. Exception: Subjects receiving warfarin anticoagulation therapy can have INR 2 to ≤ 3;
  • According to RECIST 1.1 standard, at least one measurable tumor lesion. For lesions that have received previous radiotherapy, the lesion can be included in the measurable lesion only when there is clear disease progression after radiotherapy;
  • Histologically or cytologically diagnosed as advanced malignant solid tumor;
  • Renal function Serum creatinine ≤ 1.5×ULN and creatinine clearance rate ≥ 50 mL/min;

Exclusion

  • Within 2 weeks prior to the first administration of the study drug, the subject had received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), albumin infusion and renal replacement therapy.
  • Pregnant women；
  • Other situations that the investigator considers the subject is not suitable to participate in this study.
  • Any person with difficulty in urination or urinary incontinence；
  • Currently has active infection and requires systemic anti-infection treatment (such as acute bacterial infection, tuberculosis, active hepatitis B/ C, active syphilis, etc.). Active hepatitis B is defined as: HBsAg or HBcAb test result is positive or exceeds the normal reference range, accompanied by hepatitis B virus titer \> 2500 copies/mL or 500 IU/mL (excluding subjects who received anti-hepatitis B virus treatment for at least 14 days, HBV-DNA降至≤ 2500 copies/mL or 500 IU/mL， and agreed to continue treatment during the study period)； active hepatitis C is defined as： hepatitis C antibody positive or exceeds the normal reference range and HCV-RNA positive； syphilis-specific antibody positive； HIV antibody positive；
  • Suffering from severe cardiovascular diseases, including but not limited to the following conditions:
  • Within the 4 weeks prior to the administration of 177Lu-HX02, the subject had undergone major surgery, chemotherapy, biological therapy, immunotherapy, endocrine therapy (except hormone replacement), large molecule targeted therapy or off-label drug treatment. Within the 2 weeks prior to administration, the subject had received local palliative radiotherapy, traditional Chinese medicine with anti-tumor indications, small molecule targeted drugs.
  • Baseline electrocardiogram QTcF interval prolonged (\> 480 ms);
  • New York Heart Association class II to IV congestive heart failure or left ventricular ejection fraction (LVEF) \< 50% or within the lower limit of the normal range;
  • The medical history, computed tomography (CT) or magnetic resonance imaging (MRI) examination indicated the presence of central nervous system (CNS) metastatic lesions. Excluding: CNS metastatic lesions that have undergone radiotherapy or surgery, the subject did not use corticosteroids, anticonvulsants, or diuretics to control symptoms within 2 weeks prior to the first administration, the imaging indicated no progression or new onset of brain lesions, and there were no neurological symptoms.
  • Known to be allergic to the components of the study drug or its analogues；
  • Uncontrolled hypertension (even with optimal treatment, with systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
  • Non-infectious pneumonia requiring hormone treatment and radiation pneumonitis， hemodynamic-altering thrombotic events， active bleeding events or other serious complications；
  • Within the 3 months prior to the administration of 177Lu-HX02, the subject had received radiotherapy drugs, including but not limited to: lutetium-177, radium-223, etc.
  • Suffering from claustrophobia or other conditions that prevent cooperation in PET/CT or SPECT/CT examinations；
  • Within 6 months prior to administration, suffered from acute myocardial infarction, unstable angina pectoris, or received coronary angioplasty or stent;
  • Patients with mental disorders such as depression， schizophrenia， delusion， hallucination or suicidal ideation；