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临床试验 NCT07491497 针对ALK阳性非小细胞肺癌，ALK-Positive Lung Cancer，ALK阳性非小细胞肺癌目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC I期, II期 160
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临床试验NCT07491497旨在研究治疗，主要针对ALK阳性非小细胞肺癌，ALK-Positive Lung Cancer，ALK阳性非小细胞肺癌。这是一项I期 II期 干预性研究试验，目前试验状态为招募中。试验始于2026年3月11日，计划招募160名患者。该研究由TRIANA Biomedicines, Inc.主导，预计于2034年1月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月25日。
简要概括
The goal of this clinical trial is to learn about the safety and recommended dose of TRI-611 when administered to adults with ALK-positive non-small cell lung cancer (NSCLC). The trial will also evaluate the antitumor activity of TRI-611 in adults with ALK-positive NSCLC.
The study will be conducted in two parts. The first part will examine different doses of TRI-611. The second part will look at how well TRI-611 wo...
显示更多详细描述
This is a Phase 1/2 dose escalation and dose expansion study designed to evaluate the safety and tolerability of TRI-611, identify the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in participants with ALK-positive NSCLC.
Part 1 of the study consists of a dose escalation to determine the MTD and/or recommended dose(s) of TRI-611 for further exploration i...
显示更多官方标题
A Phase 1/2, Dose Escalation and Expansion Study of TRI-611, an Oral ALK Molecular Glue Degrader in Participants With Advanced ALK-Positive NSCLC
疾病
ALK阳性非小细胞肺癌ALK-Positive Lung CancerALK阳性非小细胞肺癌其他研究标识符
- TRI-611-101
NCT编号
实际开始日期
2026-03-11
最近更新发布
2026-03-25
预计完成日期
2034-01-30
计划入组人数
160
研究类型
干预性研究
试验分期 (阶段)
I期
II期
II期
试验状态
招募中
主要目的
治疗方法
分配方式
非随机
干预模型
序贯设计
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Part 1: Dose Escalation and Backfill Prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line | TRI-611 oral ALK molecular glue degrader |
实验性Part 2: Cohort M1 Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is excluded | TRI-611 oral ALK molecular glue degrader |
实验性Part 2: Cohort M2 Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is required | TRI-611 oral ALK molecular glue degrader |
实验性Part 2: Cohort M3 Participants without prior ALK TKI treatment | TRI-611 oral ALK molecular glue degrader |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Part 1: Treatment emergent adverse events | Treatment emergent adverse events (TEAEs) | Within 28 days of the first TRI-611 dose |
Part 2: Objective response rate (ORR) | Determine the objective response rate (ORR) based on RECIST v1.1 | Approximately 16 weeks after the last participant dosed in Part 2 |
Part 2: Depth of response (DofR) | Defined as the greatest percentage reduction in the sum of diameters of target lesions from baseline | Approximately 16 weeks after the last participant dosed in Part 2 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Part 1: Half-life (t1/2) of TRI-611 | Determine the t1/2 of TRI-611 | Pre-dose and up to 24 hours post-dose |
Part 1: Area under the curve (AUC) of TRI-611 | Determine the AUC of TRI-611 | Pre-dose and up to 24 hours post-dose |
Part 1: Maximum plasma concentration (Cmax) of TRI-611 | Determine the Cmax of TRI-611 | Pre-dose and up to 24 hours post-dose |
Part 1: Minimum plasma concentration (Cmin) of TRI-611 | Determine the Cmin of TRI-611 | Pre-dose and up to 24 hours post-dose |
Part 1: ORR | Determine the ORR based on RECIST v1.1 | Approximately 16 weeks after the last participant dosed in Part 1 |
Part 1: DofR | Defined as the greatest percentage reduction in the sum of diameters of target lesions from baseline | Approximately 16 weeks after the last participant dosed in Part 1 |
Parts 1&2: Duration of response (DOR) | Determine the DOR based on RECIST v1.1 | Approximately 5 years after the last participant is dosed with TRI-611 |
Parts 1&2: Disease control rate (DCR) | Defined as the number and percentage of participants who have achieved a response or stable disease based on RECIST v1.1 | Approximately 16 weeks after the last participant dosed |
Parts 1&2: Clinical Benefit Rate (CBR) | Defined as the number and percentage of participants who have achieved a response or stable disease based on RECIST v1.1 maintained for a minimum of 6 months | Approximately 9 months after the last participant is dosed |
Parts 1&2: Progression-free survival (PFS) | Determine PFS based on RECIST v1.1 | Approximately 5 years after the last participant is dosed with TRI-611 |
Parts 1&2: Overall survival (OS) | Determine OS based on RECIST v1.1 | Approximately 5 years after the last participant is dosed with TRI-611 |
Parts 1&2: Central Nervous System (CNS) objective response rate (ORR) | Determine CNS ORR based on modified RECIST (mRECIST v1.1) in participants with CNS metastasis at baseline | Approximately 16 weeks after the last participant dosed |
Parts 1&2: CNS duration of response (DOR) | Determine CNS DOR based on mRECIST v1.1 in participants with CNS metastasis at baseline | Approximately 5 years after the last participant is dosed with TRI-611 |
Parts 1&2: Time to intracranial progression (TTP) | Defined as the time to the date of the first documentation of objective progression of intracranial disease | Approximately 5 years after the last participant is dosed with TRI-611 |
Part 1: Profile changes in tumor ALK-fusion protein levels | Assessing treatment-induced modulation of ALK expression only in participants consenting to on-treatment biopsies | Approximately 14 days after the last dose of participants in Part 1 that have consented to on-treatment biopsies |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Pathologically confirmed diagnosis of ALK-positive non-small cell lung cancer (NSCLC)
- Measurable disease per RECIST v1.1
- Adequate bone marrow reserve and organ function
- Part 1: prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line
- Part 2 Cohort M1: prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line, prior treatment with neladalkib is excluded
- Part 2 Cohort M2: prior treatment with more than 3 ALK TKIs, prior treatment with lorlatinib and neladalkib is required but neither may have been in the first line
- Part 2 Cohort M3: participants without prior ALK TKI treatment
- Participant's cancer has any additional driver alterations known to be a mechanism of resistance to ALK TKIs
- For participants with central nervous system (CNS) metastases or spinal cord compression, they must not be associated with progressive neurological symptoms or require increasing doses of corticosteroids to control the CNS disease
- Ongoing treatment with another anticancer treatment or investigational agent
- Known allergy/hypersensitivity to TRI-611 or any of its ingredients
- Major surgery within 4 weeks of receiving the first dose of TRI-611
TRIANA Biomedicines, Inc.研究中心联系人
联系人: TRIANA Clinical Trials, [email protected]
5 位于 1 个国家/地区的研究中心
New York
Memorial Sloan-Kettering Cancer Center, New York, New York, 10065, United States
Alexander Drilon, MD, 主要研究者
招募中
Ohio
Taylor Cancer Research Center, Maumee, Ohio, 43537, United States
John Nemunaitis, MD, 主要研究者
招募中
Tennessee
SCRI Oncology Partners, Nashville, Tennessee, 37203, United States
Melissa Johnson, MD, 主要研究者
招募中
Utah
START Mountain Region, West Valley City, Utah, 84119, United States
José Pacheco, MD, 主要研究者
招募中
Virginia
NEXT Virginia, Fairfax, Virginia, 22031, United States
Alexander Spira, MD, 主要研究者
招募中