Renal clear cell carcinoma, invasive breast carcinoma, and lung adenocarcinoma
Conditions
Interventions
Locally advanced, recurrent, or metastatic colorectal cancer (CRC):177Lu-R10306 SPECT/CT
Locally advanced, recurrent, or metastatic renal clear cell carcinoma:177Lu-R10306 SPECT/CT
Locally advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC):177Lu-R10306 SPECT/CT
Locally advanced, recurrent, or metastatic breast cancer:177Lu-R10306 SPECT/CT
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained prior to study participation; 2. Age >= 18 years old; 3. Subjects with the following advanced tumors confirmed histologically or cytologically:Cohort 1: Locally advanced, recurrent, or metastatic breast cancer;Cohort 2: Locally advanced, recurrent, or metastatic renal clear cell carcinoma;Cohort 3: Locally advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC);Cohort 4: Locally advanced, recurrent, or metastatic colorectal cancer (CRC); 4. At least one measurable tumor lesion confirmed by conventional imaging (CT or MRI) within 60 days prior to the administration of 177Lu-R10306 (per RECIST 1.1 criteria: longest diameter >= 1.0 cm for soft tissue tumor lesions; shortest diameter >= 1.5 cm for lymph node lesions). 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 6. Estimated survival time > 3 months. 7. Adequate organ function:Bone marrow reserve: Absolute Neutrophil Count (ANC) >= 1.5×10?/L, Platelet Count >= 100×10?/L, Hemoglobin >= 85 g/L; Liver function: Total Bilirubin (TBIL) <= 1.5 × Upper Limit of Normal (ULN), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) <= 3.0 × ULN (<= 5.0 × ULN for patients with liver metastasis); Renal function: Serum Creatinine (SCr) <= 1.5 × Upper Limit of Normal (ULN).
Exclusion criteria
Exclusion criteria: 1. Prior receipt of imaging or treatment with any same-target (KISS1R) radioligand products as 177Lu-R10306. 2. Active participation in any other clinical trial or receipt of investigational drugs. 3. Administration of other radionuclides prior to 177Lu-R10306 without completion of washout for 10 physical half-lives. 4. Receipt of external beam radiotherapy within 14 days prior to 177Lu-R10306 administration. 5. Receipt of surgical procedures within 21 days prior to 177Lu-R10306 administration or anticipated surgical treatment during the trial. 6. Patients with symptomatic CNS (Central Nervous System) metastases or those receiving corticosteroid therapy to maintain the integrity of neurological function. 7. Concurrent other malignant tumors that may interfere with disease assessment; patients with a prior history of malignant tumors that have been adequately treated, with no treatment for more than 3 years prior to enrollment and no evidence of recurrence are eligible for the study. 8. Concurrent severe or poorly controlled medical conditions, including but not limited to uncontrolled infections (severe enough to require hospitalization or continuous antibiotic treatment). 9. Concurrent severe cardiovascular diseases, such as New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, drug-dependent arrhythmias; history of myocardial infarction (MI), angina pectoris, or coronary artery bypass grafting (CABG) within 6 months prior to study treatment. 10. Patients with known active hepatitis B or C. 11. Subjects anticipated to be unwilling or unable to undergo SPECT/CT scans for any reason during the trial. 12. History of physical or psychiatric illness that may interfere with the study objectives and assessments, or other circumstances affecting trial compliance as determined by the investigator. 13. History of hypersensitivity to any components of the 177Lu-R10306 product. 14. Pregnant or lactating females, or patients who refuse to use effective contraceptive measures or abstain from sexual activity. 15. Other conditions deemed unsuitable for trial participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biodistribution Analysis;safety indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| lesion detection rate;Radioactive Absorbed Dose Analysis;Image Quality and Optimal Imaging Time; | — |
Countries
China
Contacts
Public ContactRui Gao
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed