NCT06641908招募中1 期
A Phase 1, Two-Part, Multicenter, Open-Label First in Human Study of Anti-GD2 Antibody Drug Conjugate M3554 in Participants With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 21
- 主要终点
- Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to establish the recommended doses and further evaluate the safety and preliminary antitumor activity of M3554 in participants with soft tissue sarcoma (STS) and glioblastoma, IDH-wildtype.
Study details include:
Study Duration per participant: Approximately 4 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Escalation A: participants with documented histopathological diagnosis of locally advanced or metastatic STS with unresectable disease that has progressed after at least one prior line of anthracycline-containing systemic therapy for the locally advanced/metastatic setting.
- •Participants with resectable locally advanced or metastatic disease, who had surgery before study entry will be allowed in the trial if there is residual disease after surgery and if the surgery was performed at least 4 weeks before first dose of study intervention.
- •Escalation B: participants with documented histopathological diagnosis of glioblastoma, IDH-wildtype, who have progressed after ONLY one prior line of therapy (including radiotherapy +/- temozolomide, depending on the O^6-methylguanine-DNA methyltransferase [MGMT] status) and relapsing at least 3 months after the end of the radiotherapy treatment.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1
- •Participants with adequate hematologic, hepatic and renal function as defined in protocol
- •Other protocol defined inclusion criteria could apply
排除标准
- •Participant has a history of malignancy other than STS or glioblastoma (depending on the escalation/expansion cohort) within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence within 3 years).
- •STS only: Participants with history of brain metastasis, leptomeningeal metastasis, or participants with spinal cord compression
- •Other protocol defined exclusion criteria could apply.
研究组 & 干预措施
Dose Escalation: M3554 Monotherapy
Experimental
干预措施: M3554 (Drug)
结局指标
主要结局
Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)
时间窗: up to 4 months
次要结局
- Change from Baseline in Corrected QT Interval (QTc) Interval(Pre-dose on Day 1 (baseline) up to 24 hours post-dose Day 1, Day 2, Day 5, Day 8 of Cycle 1 and Cycle 3 Day 1 (each Cycle is 21 days))
- Pharmacokinetic (PK) Plasma Concentrations of M3554(Cycle 1 Day 1 to Cycle 3 Day 15 and every second cycle from Cycle 4 (each cycle is of 21 days), assessed up to approximately 4 months)
- Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 as Assessed by Investigator(Time from randomization to planned assessment at 4 months)
- Duration of Response (DoR) According to RECIST Version 1.1 or RANO 2.0 as Assessed by Investigator(Time from randomization to planned assessment at 4 months)
- Progression-free Survival (PFS) According to RECIST Version 1.1 or RANO 2.0 as Assessed by Investigator(Time from randomization to planned assessment at 4 months)
研究者
研究点 (21)
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