RPTR-1-201在晚期实体瘤中的早期阶段试验 (RaPTR-101)
RPTR-1-201（一种T细胞受体双特异性疗法）在晚期实体瘤中的1/2期试验
This is an early phase trial designed to evaluate the safety, tolerability, and preliminary antitumor activity of RPTR-1-201 in adults with advanced solid tumors. The trial includes dose escalation and dose expansion parts and will evaluate RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Dublin、爱尔兰
- 招聘中
- START Dublin
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接触：
- Amy Slater
- 电话号码：+353 1 854 5946
- 邮箱：amy.slater@startdublin.com
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Michigan
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Grand Rapids、Michigan、美国、49546
- 招聘中
- START Midwest
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接触：
- Jacob Goldberg
- 电话号码：616-954-5561
- 邮箱：jacob.goldberg@startresearch.com
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New York
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Lake Success、New York、美国、11042
- 招聘中
- START New York-Long Island
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接触：
- Sadia Morium
- 电话号码：363-207-5160
- 邮箱：sadia.morium@startresearch.com
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Texas
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San Antonio、Texas、美国、78229
- 招聘中
- START San Antonio
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接触：
- Danielle Gillen
- 电话号码：726.215.6915
- 邮箱：danielle.gillen@startresearch.com
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Lisbon、葡萄牙
- 招聘中
- START Lisbon
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接触：
- Patrícia Alves
- 电话号码：+351 926 336 629
- 邮箱：startupeu@startresearch.com
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Barcelona、西班牙
- 招聘中
- START Barcelona
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接触：
- Monica Alemany
- 电话号码：7988 34 932 54 50 30
- 邮箱：monica.alemany@start-barcelona.com
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Logroño、西班牙
- 招聘中
- START Rioja
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接触：
- Manuel Vaz Herencia
- 电话号码：+34941056827
- 邮箱：Manuel.Vaz@startrioja.com
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Madrid、西班牙
- 招聘中
- Clinica Universidad de Navarra - Madrid
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接触：
- Pilar Nuñez
- 电话号码：+34 91 353 19 20
- 邮箱：eecc@unav.es
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Madrid、西班牙
- 招聘中
- START Madrid-FJD
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接触：
- Paloma Delgado
- 电话号码：0034 913 96 41 20
- 邮箱：paloma.delgado@startmadrid.com
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Madrid、西班牙
- 招聘中
- START Madrid-CIOCC
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接触：
- Javier Arnau
- 电话号码：(+34) 913 96 41 30
- 邮箱：Javier.Arnau@startmadrid.com
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接触：
- Dalmazio Danini
- 电话号码：(+34) 917 56 78 25
- 邮箱：dalmazio.danini@startmadrid.com
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Pamplona、西班牙
- 招聘中
- Clinica Universidad de Navarra - Pamplona
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接触：
- Pilar Nuñez
- 电话号码：+34 948 255 400
- 邮箱：eecc@unav.es
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Valencia、西班牙
- 招聘中
- INCLIVA Instituto de Investigación Sanitaria VLC
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接触：
- María Burgos Guerra
- 电话号码：+34 961 973 500
- 邮箱：mburgos@incliva.es
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors that is not amenable to curative treatment.
- At least one measurable lesion per RECIST v1.1 as assessed by the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function as defined in the trial protocol.
- Ability to provide written informed consent and comply with trial procedures.
Exclusion Criteria:
- History of another malignancy within 3 years before the first dose of trial intervention, with the exception of malignancies considered cured and not expected to require active therapy (for example, certain skin cancers or in situ malignancies) per protocol.
- Known active leptomeningeal disease or uncontrolled central nervous system metastases.
- Active, clinically significant, autoimmune diseases requiring systemic immunosuppressive therapy.
- Prior allogenic organ transplantation
- Clinically significant uncontrolled medical or psychiatric condition, that in the opinion of the investigator, would increase risk or interfere with trial participation.
- Other protocol-defined inclusion and exclusion criteria apply
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Monotherapy
Participants receive RPTR-1-201 at doses and schedules defined by the trial protocol. |
RPTR-1-201 |
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实验性的：Combination
Participants receive RPTR-1-201 in combination with an approved or investigational PD-1 monoclonal antibody at doses and schedules defined by the trial protocol. |
RPTR-1-201 PD-1/PD-L1 monoclonal antibody |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of participants with dose-limiting toxicities and treatment-emergent adverse events.
大体时间：From first dose through 30 days after last dose of trial treatment.
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Number of participants experiencing dose-limiting toxicities and treatment-emergent adverse events, including events considered related to RPTR-1-201, graded according to CTCAE v5.0. |
From first dose through 30 days after last dose of trial treatment.
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Objective Response Rate (ORR) per RECIST v1.1
大体时间：From first dose until end of treatment or documented disease progression, whichever occurs first (assessed up to 24 months).
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Proportion of participants with a best overall response of complete response or partial response per RECIST v1.1, as assessed by the investigator. |
From first dose until end of treatment or documented disease progression, whichever occurs first (assessed up to 24 months).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence and severity of adverse events and abnormal safety assessments.
大体时间：From first dose through 30 days after last dose of trial treatment
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Incidence and severity of adverse events, including immune-related adverse events, and abnormal safety assessments (clinical laboratory tests, ECGs, vital signs). |
From first dose through 30 days after last dose of trial treatment
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Pharmacokinetics of RPTR-1-201
大体时间：First dose until end of treatment (assessed up to 24 months).
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Characterization of the pharmacokinetic maximum observed concentration of RPTR-1-201. |
First dose until end of treatment (assessed up to 24 months).
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Progression Free Survival (PFS)
大体时间：From first dose until disease progression, death, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
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Time from first dose of RPTR-1-201 to the earliest date of documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first. |
From first dose until disease progression, death, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
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Overall survival (OS)
大体时间：From first dose until death from any cause or end of trial follow-up, whichever occurs first (assessed up to 36 months).
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Time from first dose of RPTR-1-201 to death from any cause. |
From first dose until death from any cause or end of trial follow-up, whichever occurs first (assessed up to 36 months).
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Time to Response
大体时间：From first dose until first documented response, disease progression, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
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Time from first dose of RPTR-1-201 to the first documented complete response or partial response per RECIST v1.1. |
From first dose until first documented response, disease progression, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
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Pharmacokinetics of RPTR-1-201 (AUC)
大体时间：First dose until end of treatment (assessed up to 24 months)
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Characterization of the pharmacokinetic area under the curve of RPTR-1-201 |
First dose until end of treatment (assessed up to 24 months)
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Immunogenicity of RPTR-1-201
大体时间：First dose until end of treatment (assessed up to 24 months)
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Characterization of the incidence of anti-drug antibodies of RPTR-1-201. |
First dose until end of treatment (assessed up to 24 months)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.