NCT06016270终止1 期
A Phase Ib/II Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- STCube, Inc.
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this clinical study is to assess the safety and efficacy of hSTC810 and paclitaxel combination therapy in patients with relapsed or refractory extensive stage small cell lung cancer.
详细描述
The study will be conducted in 2 parts. Phase Ib will evaluate the safety of the combination of hSTC810 with a standard dose of paclitaxel using a 3+3 dose escalation design. Phase II will evaluate the efficacy of hSTC810 + paclitaxel combination therapy using a Simon 2-stage method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Ability to understand and sign an informed consent form
- •Male or female ≥ 18 years of age
- •Histologically or cytologically confirmed SCLC
- •R/R ES-SCLC on or after platinum-based chemotherapy for SCLC with documented disease progression
- •At least 1 measurable lesion as defined by RECIST 1.1
- •Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 or 1
- •Life expectancy of at least 3 months
- •Adequate organ function as described in the protocol
- •For female or male patients with reproductive potential: Agree to use contraception throughout the study and at least 5 months after the last dose.
排除标准
- •Known active leptomeningeal disease (carcinomatous meningitis)
- •Known active and uncontrolled central nervous system (CNS) metastases
- •Treatment with immunotherapy, chemotherapy, targeted small molecule therapy, or any other investigational agent < 14 days prior to initiation of study treatment
- •Treatment with radiation therapy < 14 days prior to initiation of study treatment
- •Major surgery < 21 days prior to initiation of study treatment
- •Received live vaccine < 30 days prior to initiation of study treatment, including intranasal influenza vaccine
- •History of another primary malignancy with protocol-defined exceptions
- •Active or history of autoimmune disease requiring systemic treatment
- •Receiving high doses of steroids or other immunosuppressive medications
- •Active hepatitis B or C infection
- •Active or history of non-infectious pneumonitis requiring treatment with steroids
- •Active uncontrolled viral, fungal, or bacterial infection including tuberculosis
- •Pregnant or breastfeeding female patients
- •History of severe hypersensitivity reaction to a monoclonal antibody treatment
- •History of severe hypersensitivity reaction or ≥ Grade 3 adverse event (AE) to paclitaxel treatment
- •History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to screening
- •QT Corrected for Fridericia's method (QTcF) > 470 ms at screening
- •Lack of resolution of any toxicity to max Grade 1 (except alopecia)
- •Active or history of any condition, therapy, or lab abnormality that may interfere with the patient participation for the full duration of the study
- •Known psychiatric or substance use disorder
- •Positive Coronavirus disease 2019 (COVID-19) test at screening
研究组 & 干预措施
hSTC810 400 mg + Paclitaxel
Experimental
hSTC810 400 mg will be administered with a standard dose of paclitaxel
干预措施: hSTC810 400 mg + Paclitaxel (Drug)
hSTC810 800 mg + Paclitaxel
Experimental
hSTC810 800 mg will be administered with a standard dose of paclitaxel
干预措施: hSTC810 800 mg + Paclitaxel (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 3 months
Percentage of patients with confirmed Confirmed Response (CR) or Partial Response (PR) as defined by RECIST 1.1 at 3 months
Progression Free Survival (PFS) rate
时间窗: 6 months
Proportion of patients without documented progression of disease and alive at 6 months
次要结局
- Clinical Benefit Rate (CBR)(Up to 4 years)
- Overall Survival (OS)(Up to 4 years)
- Overall Survival (OS) rate(12 months)
- Safety and tolerability(Up to 4 years)
- Progression Free Survival (PFS)(Up to 4 years)
- Overall Response Rate (ORR)(Up to 4 years)
- Duration of Response (DoR)(Up to 4 years)
- Maximum plasma concentration (Cmax)(Up to 21 days)
- Area under the concentration-time curve from 0 to 21 days (AUC0-21)(Up to 21 days)
- Area under the concentration-time curve extrapolated from 0 to infinity (AUCo-inf)(Up to 21 days)
- Incidence of anti-drug antibodies (ADA)(Up to 4 years)
研究者
研究点 (8)
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