NCT06898437招募中1 期
Clinical Trial to Evaluate the Antitumor Efficacy and Safety of 177Lu-LNC1004 Injection in Patients With Fibroblast Activating Protein (FAP)-Positive Radioiodine-refractory Differentiated Thyroid Cancer (RAIR-DTC) Who Have Failed TKIs Treatment or Refuse Standard Treatment
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
177Lu-LNC1004 Injection, a radiopharmaceutical targeting FAP, has demonstrated preliminary antitumor effect in advanced FAP-positive solid tumor patients. The primary purpose of this study is to evaluate the efficacy of 177Lu-LNC1004 Injection in patients with FAP-positive RAIR-DTC who have failed first-line TKIs treatment or refuse standard treatment. All subjects will receive 80 mCi (± 10%) 177Lu-LNC1004 Injection intravenously every 6 weeks for 2 cycles.
详细描述
This prospective, single-arm, open label, single-center clinical trial is planned to enroll approximately 20 RAIR-DTC subjects s who have failed TKIs treatment or refuse standard treatment. All subjects will receive 80 mCi (± 10%) 177Lu-LNC1004 Injection intravenously every 6 weeks for 2 cycles. Disease progression and occurrence of AEs will be monitored during the trial. Based on tumor response assessment and AEs occurrence in the first 2 cycles, subjects may continue to receive 177Lu-LNC1004 Injection for a maximum of 6 cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have the ability to understand and sign an approved informed consent form (ICF).
- •Aged 18 years or older, regardless of sex.
- •Histologically or cytologically confirmed RAIR-DTC subject who has failed TKIs treatment or refuse standard therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •At least one measurable lesion as defined by Response Criteria in Solid Tumors (RECIST) version 1.
- •Life expectancy of at least 6 months.
- •FAP-positive lesion confirmed by FAPI PET/CT scan.
- •Adequate organ function as defined by：
- •Bone marrow function: hemoglobin ≥ 100 g/L, neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L;
- •Liver function: albumin ≥ 3.0 g/dL; total bilirubin ≤ 1.5 × ULN; ALT and AST < 3 × ULN without liver metastasis or < 5 × ULN with liver metastasis;
- •Renal function: creatinine clearance ≥ 60 mL/min.
- •Clinically significant toxic reactions related to prior antitumor treatment that have recovered to Grade ≤ 1 (CTCAE V5.0).
排除标准
- •Known central nervous system metastases, except for the following:
- •Subject without clinical symptoms can be included in this trial after evaluation by the investigator.
- •Brain metastases that have been previously treated and confirmed by image to be stable for at least 4 weeks.
- •Secondary malignancy was detected within 5 years prior to first dosing, excluding cured localized carcinoma including cervical carcinoma in situ, basal cell skin cancer, and prostate cancer in situ, etc.
- •Received antitumor treatment including chemotherapy, radiotherapy, immunotherapy, and traditional Chinese medicine, etc. within 4 weeks prior to first dosing.
- •Subject who previously received targeted therapy, but discontinued treatment for less than 4 weeks or 10 half-lives prior to first dosing.
- •Received systemic radionuclide therapy or radioembolization within 6 months before first dosing or any external beam radiotherapy within 2 weeks before the first dosing.
- •Known allergy to 177Lu-LNC1004 Injection or similar drugs.
- •Subject has not fully recovered from major surgery prior to first dosing or expects to have major surgery during the study period.
- •Accompanied with severe cardiovascular and cerebrovascular diseases, including but not limited to:
- •Subject who has undergone coronary angioplasty, coronary stent placement, coronary artery bypass grafting, or implantation of defibrillation devices due to arrhythmia within 6 months;
- •There are serious heart rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block, etc.
- •Clinically significant abnormal ECG during the screening period, including QTcF > 470 ms in male and QTcF > 480 ms in female.
- •New York College of Cardiology (NYHA) grade ≥
- •Aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular event (NCI CTCAE v5.0) within 6 months.
- •Subject who has active and clinically significant bacterial, fungal, viral infection, or any other uncontrolled active infections such as active tuberculosis within 4 weeks prior to first dosing.
- •Known human immunodeficiency virus (HIV) infection or positive HIV test, positive syphilis antibody test, or active hepatitis except for:
- •Subject who is positive for hepatitis B surface antigen can be enrolled if HBV DNA level is less than 1×104 copies/mL or 2000 IU/mL, and can receive antiviral treatment according to clinical judgment during the trial.
- •Subject who is positive for HCV antibodies can be enrolled if HCV RNA test is negative.
- •Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation.
- •Subject who has pleural effusion or ascites that required treatment or is deemed uncontrollable by investigator.
- •Subject who has mental illness or substance abuse, which may affect adherence to the trial.
- •Subject who refuses to take effective contraceptive measures during sexual intercourse from ICF signing to 6 months after last investigational drug administration；
- •Women who are pregnant or breastfeeding, or planning to become pregnant during the study period or within 6 months after last investigational drug administration；
- •Any other medical condition, metabolic abnormality, physical abnormality, laboratory abnormality, or other condition that the investigator deems inappropriate for study participation, or that would affect the interpretation of the study results, or place the subject at high risk, such as idiopathic pulmonary fibrosis or lung disease, urinary incontinence, etc.
研究组 & 干预措施
177Lu-LNC1004 Injection
Experimental
All subjects will be administered with 177Lu-LNC1004 Injection at 80 mCi per cycle for 2 cycles with interval of 6 weeks.
干预措施: 177Lu-LNC1004 Injection (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: up to 24 months
ORR is defined as the the proportion of subjects who achieve a best overall response of Complete Response (CR) or Partial Response (PR).
次要结局
- Disease Control Rate (DCR)(up to 24 months)
- Duration of Response (DoR)(up to 24 months)
- Progression Free Survival (PFS)(up to 24 months)
- Biochemical Response (BR)(up to 24 months)
- Safety(up to 24 months)
研究者
Yansong Lin
Prof. M.D
Peking Union Medical College Hospital
研究点 (1)
Loading locations...
相似试验
终止
1 期
A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors.Pancreatic Ductal AdenocarcinomaGastroesophageal AdenocarcinomaGlioblastoma MultiformeNCT05977322Novartis Pharmaceuticals24
撤回
1 期
CD19- and CD22-directed CAR-T Cell Therapy in Patients With Acute Lymphoblastic LeukemiaAcute Lymphoblastic LeukemiaNCT05168748Novartis Pharmaceuticals
已完成
1 期
Lutetium-177-PSMA-617 in Low Volume Metastatic Prostate CancerProstate NeoplasmNCT03828838Radboud University Medical Center10
Unknown
1 期
Safety Study of a Radiolabeled Antibody (7E11) in Patients With Progressive Hormone Refractory Prostate CancerMetastatic Prostate CancerNCT00441571Cytogen Corporation30
进行中（未招募）
1 期
Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate CancerBiochemically Recurrent Prostate CarcinomaProstate AdenocarcinomaNCT06105918Emory University6