Advanced malignant solid tumor
Conditions
Interventions
Experimental Group:A total of four incremental doses were preset in this study: 50 mCi, 100 mCi, 150 mCi, and 200mCi. Each dose is administered once. During the trial period, based on the safety/toler
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood this research and voluntarily signed the informed consent form; 2. Age: 18 to 75 years old, gender not limited. 3. The ECOG score is 0 to 1, and it can tolerate PET/CT and SPECT/CT examinations. 4. Expected survival period: >=6 months; 5. Confirmed as advanced malignant solid tumor by histology or cytology; 6. Failure of previous standard treatment; 7.68Ga-HX01 positive PET/CT imaging. It is defined as the presence of at least one lesion with SUVmax=3.0 or tumor-liver ratio (SUVmax/SUVmean) (T/L ratio) > 1 in 68Ga-HX01 PET/CT imaging; 8. According to the RECIST 1.1 standard, there is at least one measurable tumor lesion. For lesions that have undergone radiotherapy in the past, they can only be included in measurable lesions if there is a clear disease progression after radiotherapy. 9. The toxicity of previous anti-tumor treatments (such as previous chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) has recovered to a level of = grade 1 (except for hair loss); 10. The functional level of organs must meet the following requirements: a) Bone marrow Neutrophil count >=1.5×10^9/L and white blood cell count >=2.5×10^9/L; Platelet count >=100×10^9/L; Hemoglobin >=90 g/L; b) Liver function Total bilirubin 30 g/L; c) Renal function Serum creatinine =50 mL/min; d) Coagulation function International normalized ratio (INR) <=2.0, activated Partial thromboplastin time (APTT) <=1.5×ULN. Exceptional case: Subjects receiving warfarin anticoagulation therapy may receive an INR of 2 to <=3; 11. Women of childbearing age must have a negative pregnancy test. Fertile subjects (and their partners) voluntarily used effective contraceptive methods, such as condoms, oral or injectable contraceptives, during the treatment period and for six months after the last use of the investigational drug.
Exclusion criteria
Exclusion criteria: 1. 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. 2. 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. 3. 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. 4. 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. 5. Suffering from severe cardiovascular diseases, including but not limited to the following conditions: a) Within 6 months prior to administration, suffered from acute myocardial infarction, unstable angina pectoris, or received coronary angioplasty or stent; b) New York Heart Association class II to IV congestive heart failure or left ventricular ejection fraction (LVEF) = 160 mmHg and/or diastolic blood pressure >=100 mmHg); d) Baseline electrocardiogram QTcF interval prolonged (> 480 ms); 6. 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<= 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; Treponema pallidum specific antibody positive; HIV antibody positive; 7. Non-infectious pneumonia requiring hormone treatment and radiation pneumonitis, hemodynamic-altering thrombotic events, active bleeding events or other serious complications; 8. Within the 5 years prior to the administration of 177Lu-HX02, the subject had any other active malignant tumors (excluding surgically resected and non-recurrent skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, local prostate cancer, in situ cervical cancer or other in situ cancers); 9. Known to be allergic to the components of the study drug or its analogues; 10. Any person with difficulty in urination or urinary incontinence; 11. Suffering from claustrophobia or other conditions that prevent cooperation in PET/CT or SPECT/CT examinations;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Adverse events (AE), vital signs, physical examination, 12-lead electrocardiogram and laboratory tests, etc.;Tolerance: Incidence of dose-limiting toxicity (DLT);Explore MTD and determine RP2D/ subsequent recommended dose.; | — |
Countries
China
Contacts
Public ContactLan Xiaoli/Chen Jing
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed