Phase 1 Open Label Trial of MST-0312 Alone and in Combination in Subjects With Solid Malignancies (STARLYS)
2026年5月20日 更新者：Mestag Therapeutics Limited
A Multi-arm, Open-label, Phase 1 Trial to Evaluate the Safety and Tolerability, Pharmacokinetics and Anti-tumour Activity of MST-0312 When Given Alone and in Combination With Anticancer Treatments in Subjects With Solid Malignancies
The STARLYS trial is an adaptive, modular, Phase 1, open-label, multi-part, clinical trial evaluating MST-0312 in selected solid tumors.
MST-0312 is a targeted bispecific antibody that is designed to locally stimulate the lymphotoxin beta receptor (LTBR) in order to boost the body's immune response to cancer.
The LTBR pathway is important in forming tertiary lymphoid structures and high endothelial venules in tumors, which have been associated with improved patient outcomes.
The purpose of this study is to determine the safety and tolerability, pharmacodynamics, pharmacokinetics and anti-tumor activity of MST-0312 in subjects with solid malignancies (initially non-small cell lung cancer (NSCLC), melanoma, bladder cancer, colorectal cancer (CRC) and triple negative breast cancer (TNBC)) when administered either as monotherapy or in combination with anti-cancer treatments (initially pembrolizumab).
The STARLYS trial is the first time MST-0312 has been administered to humans.
研究概览
研究类型
介入性
注册 (估计的)
157
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Mestag MST-0312-1001
- 电话号码：+447721893628
- 邮箱：medical@mestagtx.com
学习地点
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Barcelona、西班牙、08035
- 尚未招聘
- Hospital Universitari Vall d'Hebron
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Madrid、西班牙、28027
- 尚未招聘
- Clinica Universidad de Navarra
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Madrid、西班牙、28040
- 招聘中
- Hospital Universitario Fundación Jimenez Díaz
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Madrid、西班牙、28041
- 尚未招聘
- Hospital Universitario 12 de Octubre
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Madrid、西班牙、28050
- 招聘中
- Hospital Universitario HM Sanchinarro
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Valencia、西班牙、46010
- 尚未招聘
- Hospital Clinico Universitario de Valencia
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Male and female subjects of any ethnic origin, aged 18 years and over.
- Must have given written informed consent and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Subject must have a solid malignancy (non-small cell lung cancer (NSCLC), melanoma, bladder cancer, colorectal cancer (CRC) and triple negative breast cancer (TNBC)).
- An ECOG performance status of 0 or 1 with no deterioration over the previous two weeks.
- Willing to permit access to stored historical tumour tissue and prior tumour radiological assessments, cancer treatment history, including response to treatment, and tumour biomarker data, where available.
- Willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other trial procedures.
Exclusion Criteria:
- Any unresolved toxicity (except alopecia) from prior therapy of ≥2 CTCAE Grade.
- Active or documented history of autoimmune disease requiring interventional therapy.
- Active infection requiring systemic antibiotic, antifungal, or antiviral medication within 14 days prior to first dose of IMP.
- Male or female subjects of childbearing potential unwilling to comply with contraception requirements.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Module 1A
MST-0312 monotherapy dose escalation
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A complete treatment cycle is defined as 21 calendar days.
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实验性的：Module 1B
MST-0312 monotherapy backfill
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A complete treatment cycle is defined as 21 calendar days.
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实验性的：Module 2A
MST-0312 plus pembrolizumab dose escalation
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A complete treatment cycle is defined as 21 calendar days.
Monoclonal antibody
其他名称：
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实验性的：Module 2B
MST-0312 plus pembrolizumab backfill
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A complete treatment cycle is defined as 21 calendar days.
Monoclonal antibody
其他名称：
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实验性的：Module 2C
MST-0312 plus pembrolizumab expansion
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A complete treatment cycle is defined as 21 calendar days.
Monoclonal antibody
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Incidence of Dose-limiting Toxicities (DLTs)
大体时间：From baseline to end cycle 1. A complete treatment cycle is defined as 21 calendar days.
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From baseline to end cycle 1. A complete treatment cycle is defined as 21 calendar days.
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Incidence of Adverse Events, Treatment Emergent Adverse Events, Serious Adverse Events measured by Criteria for Adverse Events Version 6.0 (CTCAE v6.0)
大体时间：Up to 24 months
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Up to 24 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Maximum Concentration (Cmax) Derived for MST-0312
大体时间：24 months
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24 months
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Time of Maximum Concentration (Tmax)
大体时间：24 Months
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24 Months
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Area Under the Curve (AUC) for Various Time Intervals
大体时间：24 Months
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24 Months
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Half Life (t1/2) for MST-0312
大体时间：24 Months
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24 Months
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Clearance (CL) for MST-0312
大体时间：24 Months
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24 Months
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Percentage of Participants with Anti-Drug Antibodies (ADAs)
大体时间：24 Months
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24 Months
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Objective Response Rate (ORR) by RECIST 1.1 and iRECIST
大体时间：12 Months
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12 Months
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Disease Control Rate (DCR) by RECIST 1.1 and iRECIST
大体时间：12 Months
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12 Months
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Duration of Response (DoR) by RECIST 1.1 and iRECIST
大体时间：12 Months
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12 Months
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Progression Free Survival (PFS) by RECIST 1.1 and iRECIST
大体时间：12 Months
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12 Months
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Best Overall Response (BoR) by RECIST 1.1 and iRECIST
大体时间：12 Months
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12 Months
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Time To Response (TTR) by RECIST 1.1 and iRECIST
大体时间：12 Months
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12 Months
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Progression Free Survival 2 (PFS2) by RECIST 1.1 and iRECIST
大体时间：48 Months
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48 Months
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Overall Survival (OS)
大体时间：48 Months
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48 Months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月9日
初级完成 (估计的)
2029年12月31日
研究完成 (估计的)
2029年12月31日
研究注册日期
首次提交
2026年5月14日
首先提交符合 QC 标准的
2026年5月20日
首次发布 (实际的)
2026年5月28日
研究记录更新
最后更新发布 (实际的)
2026年5月28日
上次提交的符合 QC 标准的更新
2026年5月20日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- MST-0312-1001
- 2025-524446-10 (EudraCT编号)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
实体恶性肿瘤的临床试验
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AstraZeneca主动，不招人Adv Solid Malig - H&N SCC、ATM Pro / Def NSCLC、胃癌、乳腺癌和卵巢癌美国, 法国, 英国, 韩国
MST-0312的临床试验
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Centre for Addiction and Mental HealthUniversity of British Columbia; Brain Canada; Ontario Shores Centre for Mental Health Sciences完全的
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Centre for Addiction and Mental HealthUniversity of British Columbia; Brain Canada; Ontario Shores Centre for Mental Health Sciences完全的
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Centre for Addiction and Mental HealthUniversity Health Network, Toronto完全的
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Centre for Addiction and Mental HealthUniversity of British Columbia招聘中
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De ViersprongRadboud University Medical Center; Koraal; Stichting tot Steun; Prisma; MST-Netherlands/Belgium; Pactum招聘中