NCT07324629招募中2 期
A Phase II Clinical Study of Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma With Treatment Failure After Platinum-Based Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The goal of this clinical trial is to learn if drug Sac-TMT works to treat Thymic Carcinoma. It will also learn about the safety of Sac-TMT. The main questions it aims to answer are:
- How effective is drug Sac-TMT in treating Thymic Carcinoma?
- What adverse events (AEs) do participants have when taking drug Sac-TMT?
Participants will:
- Progress after at least one platinum-based chemotherapy treatment.
- Take drug Sac-TMT every 2 weeks.
- Take tumor response assessments every 6 weeks.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged ≥ 18 to ≤ 75 years at the time of signing the Informed Consent Form;
- •Participants with histologically or cytologically confirmed thymic carcinoma, and locally advanced or metastatic thymic carcinoma who are not suitable for curative intent therapy;
- •Participants with advanced thymic carcinoma who have progressed after at least one prior platinum-based chemotherapy;
- •Able to provide a tumor tissue sample at the time of or after the diagnosis of locally advanced or metastatic tumor;
- •At least one measurable target lesion that has not received radiotherapy according to RECIST v1.1;
- •ECOG performance status score of 0 or 1;
- •Expected survival ≥ 12 weeks;
- •Adequate organ and bone marrow function.
排除标准
- •Participants with histologically or cytologically confirmed thymoma or thymic neuroendocrine tumor;
- •Participants with known metastases to meninges, brainstem metastases, spinal cord metastases and/or compression, active or untreated brain metastases;
- •Participants with other malignant tumors within 3 years prior to the first dose;
- •Presence of any of conditions or risk factors related to cardiovascular and cerebrovascular diseases;
- •Uncontrolled systemic disease as judged by the investigator;
- •History of interstitial lung disease/noninfectious pneumonitis requiring steroid therapy;
- •Clinically severe pulmonary impairment due to lung disorder;
- •Presence of active hepatitis B or hepatitis C;
- •Known active tuberculosis;
- •Known hypersensitivity to the study drug or any of its components.
研究组 & 干预措施
Sac-TMT 5mg/kg Q2W
Experimental
干预措施: Sacituzumab tirumotecan (Drug)
结局指标
主要结局
ORR
时间窗: From enrollment to the end of treatment at 24 months
To evaluate the objective response rate (ORR) of sac-TMT as assessed by the investigator based on RECIST v1.1.
ORR
时间窗: From enrollment to the end of treatment at 24 months
To evaluate the objective response rate (ORR) of sac-TMT as assessed by the investigator based on RECIST v1.1.
次要结局
- PFS(From enrollment to the end of treatment at 24 months)
- OS(From enrollment to the end of treatment at 24 months)
- Incidence and severity of AEs and SAEs, and abnormal laboratory values.(From enrollment to the end of treatment at 24 months)
- PFS(From enrollment to the end of treatment at 24 months)
- OS(From enrollment to the end of treatment at 24 months)
- Incidence and severity of AEs and SAEs, and abnormal laboratory values.(From enrollment to the end of treatment at 24 months)
- DCR(From enrollment to the end of treatment at 24months)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.Advanced Triple Negative Breast CancerBreast Cancer MetastaticBreast CancerNCT07299409Nathalie Levasseur24
尚未招募
2 期
Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Toripalimab in Patients With Initially Unresectable Stage III NSCLCNon Small Cell Lung Cancer (Stage III)NCT06706219Hunan Province Tumor Hospital50
尚未招募
不适用
Sacituzumab Tirumotecan (Sac-TMT) Plus Bevacizumab in 3rd Generation EGFR-TKI Treated Advanced EGFR-mutant Nonsquamous NSCLC With Brain MetastasisLung CancerNCT07197008Li-kun Chen50
招募中
2 期
Sac-TMT Plus KL-A167 in PD-L1+, HR+/HER2- Metastatic Breast Cancer After CDK4/6 InhibitorsBreast CancerNCT07258108Sun Yat-sen University35
招募中
不适用
Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid CancerAdvanced Thyroid CarcinomaRadioiodine-refractory Differentiated Thyroid CancerPoorly Differentiated Thyroid CarcinomaNCT07068542Zhejiang Provincial People's Hospital94