NCT07689643招募中1 期
A Single-Center, Prospective, Open-Label, Investigator-Initiated Study Evaluating the Safety, Biodistribution, Radiation Dosimetry, and Preliminary Efficacy of [177Lu]Lu-RTX-2358 Combined With Immune Checkpoint Inhibitors in Patients With FAP-positive Metastatic Non-Small Cell Lung Cancer
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年4月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a prospective, single-center, open-label investigator-initiated study designed to evaluate the safety, tolerability, radiation dosimetry, biodistribution, and preliminary antitumor activity of [177Lu]Lu-RTX-2358 in combination with immune checkpoint inhibitors (ICIs) in patients with fibroblast activation protein (FAP)-positive metastatic non-small cell lung cancer (NSCLC). Eligible participants will receive one or two cycles of [177Lu]Lu-RTX-2358 followed by standard PD-1 inhibitor therapy. Safety, tumor response, biodistribution, radiation dosimetry, and survival outcomes will be evaluated throughout treatment and follow-up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained prior to any study-related procedures.
- •Age ≥ 18 years old.
- •Histologically or cytologically confirmed metastatic non-small cell lung cancer (NSCLC).
- •FAP-positive lesions confirmed by FAPI PET imaging.
- •At least one measurable lesion per RECIST version 1.1 criteria.
- •ECOG performance status 0 or
- •Estimated life expectancy ≥ 3 months.
- •Adequate bone marrow, hepatic, renal, and coagulation function.
- •Willing to comply with all radiation protection requirements throughout study participation.
- •Willing to use highly effective contraception during study treatment and post-treatment follow-up period.
排除标准
- •History of another active malignancy requiring treatment within 2 years before the first administration of [177Lu]Lu-RTX-2358, except adequately treated basal cell carcinoma of the skin or carcinoma in situ treated with curative intent.
- •Symptomatic brain metastases or central nervous system metastases requiring active treatment. Participants with previously treated brain metastases are eligible if the disease has remained clinically and radiographically stable for at least 24 weeks.
- •Symptomatic spinal cord compression or radiographic evidence of impending spinal cord compression.
- •Major surgery, open biopsy (excluding needle biopsy), or significant traumatic injury within 4 weeks before the first administration of [177Lu]Lu-RTX-
- •Prior treatment with any radioligand therapy or therapeutic radiopharmaceutical.
- •Receipt of systemic anticancer therapy, including chemotherapy, immunotherapy, targeted therapy, biologic therapy, investigational agents, or antitumor traditional Chinese medicine, within 21 days before the first administration of [177Lu]Lu-RTX-2358, unless the protocol-defined washout period has been satisfied.
- •Receipt of curative radiotherapy within 6 weeks before the first administration of [177Lu]Lu-RTX-
- •Palliative radiotherapy is permitted if completed at least 2 weeks before treatment, involves less than 10% of bone marrow, and does not include target lesions.
- •Unresolved toxicities from previous anticancer therapy greater than Grade 1 according to NCI CTCAE version 5.0, except stable chronic toxicities judged by the investigator not to pose a safety risk (e.g., alopecia, peripheral neuropathy, or fatigue).
- •Endocrine dysfunction involving the thyroid, adrenal, pituitary, or pancreas that would preclude treatment with immune checkpoint inhibitors.
- •Known interstitial lung disease, immune-related pneumonitis, pulmonary fibrosis, or active pulmonary fibrosis.
- •Severe urinary incontinence, hydronephrosis, bladder outlet obstruction, or other clinically significant urinary tract disorders that may interfere with radiopharmaceutical clearance.
- •Clinically significant cardiovascular disease, including myocarditis, pericarditis, myocardial infarction, unstable angina, New York Heart Association Class III or IV heart failure, uncontrolled arrhythmias, uncontrolled hypertension, or conditions associated with clinically significant QT interval prolongation within 6 months before enrollment.
- •Active uncontrolled infection, including human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C infection, active syphilis, or any infection requiring systemic therapy that is not adequately controlled.
- •Serious or non-healing wounds, active ulcers, or fractures requiring ongoing treatment.
- •Severe psychiatric illness or any medical condition that, in the investigator's judgment, would compromise participant safety, interfere with study participation, or affect protocol compliance.
- •Pregnant or breastfeeding women.
- •Known hypersensitivity to [177Lu]Lu-RTX-2358 or any of its components. History of significant occupational exposure to ionizing radiation exceeding applicable regulatory limits.
- •Participation in another interventional clinical trial within 4 weeks before screening.
- •Inability or unwillingness to undergo required study procedures, including PET/CT, SPECT/CT, CT/MRI examinations, or inability to comply with protocol requirements.
- •Any other condition that, in the investigator's judgment, would make the participant unsuitable for participation in this study.
研究组 & 干预措施
[177Lu]Lu-RTX-2358 plus Immune Checkpoint Inhibitor
Experimental
Participants will receive one or two intravenous administrations of [177Lu]Lu-RTX-2358 in combination with standard PD-1 inhibitor therapy. The treatment schedule depends on cohort assignment.
干预措施: [177Lu]Lu-RTX-2358 (Drug)
结局指标
主要结局
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
时间窗: From the first administration of [177Lu]Lu-RTX-2358 until 30 days after the last administration of study treatment.
To evaluate the safety and tolerability of \[177Lu\]Lu-RTX-2358 in combination with a PD-1 inhibitor by assessing the incidence, severity, seriousness, and relationship of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs), graded according to NCI CTCAE version 5.0.
次要结局
- Objective Response Rate (ORR)(From baseline until disease progression, initiation of new anticancer therapy, death, or up to 12 months after the last study treatment, whichever occurs first.)
- Disease Control Rate (DCR)(Up to 12 months after the last study treatment.)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
CD19 CAR-T Therapy for Refractory Pemphigus VulgarisPemphigus VulgarisNCT07681388Jinbo Chen3
招募中
1 期
BY002 IIT Study in R/R Acute LeukemiaAcute LeukemiaNCT07270770The First Affiliated Hospital of Soochow University18
招募中
2 期
Toripalimab Combined With BCG Perfusion for the Treatment of HR-NMIBC After TURBT Surgery ExplorationBladder CancerNCT07307456Changhai Hospital31
尚未招募
4 期
Use of Cariprazine drug in Indian patients having Major Depressive DisorderCTRI/2024/01/062163Not Applicable100
招募中
不适用
Study to Evaluate the Effectiveness of Deferiprone Capsules in Patients Recovering from a Recent Heart AttackCTRI/2024/08/072100Synergy Superspecialty Hospital30