jRCT2031220326进行中（未招募）不适用
An Open-label, Multicenter Trial of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M1774 in Participants with Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 17
- 主要终点
- Occurrence of DLTs during the DLT observation period
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator (i.e., participants who have exhausted all standard of care options according to International Guidelines), which may convey clinical benefit.
- •Part A3 only: Participants whose tumor has at least 1 of the following molecular defects:
- •Cohort 1: loss of function mutations in the gene for ARID1A
- •Cohort 2: loss of function mutations in the genes for ATRX and/or DAXX
- •Cohort 3: loss of function mutation in the gene for ATM.
- •Part A4 only: participants who are resident in Japan and self-report Japanese ethnicity
- •Part A3 only: measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.
- •Adequate hematologic function
- •Adequate hepatic function
- •Adequate renal function
- •Other protocol defined inclusion criteria could apply
排除标准
- •Presence of toxicities due to prior anticancer therapies (e.g., radiotherapy, chemotherapy, immunotherapies, etc.) that do not recover to <= Grade 1 with the exception of toxicities that do not pose a safety risk to the participant in the judgment of the Investigator (e.g., ongoing Grade 2 alopecia).
- •Unstable angina, myocardial infarction, congestive heart failure >= II or a coronary revascularization procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of > 450 msec for males and > 470 msec for females, that does not resolve with correction of electrolyte abnormalities.
- •Any other clinical condition or uncontrolled concurrent illness which in the Investigator's opinion would not make the participant a good candidate for the clinical study
- •Concurrent treatment with a nonpermitted drug/intervention
- •Other protocol defined exclusion criteria could apply.
结局指标
主要结局
Occurrence of DLTs during the DLT observation period
时间窗: DLT observation period
Occurrence of DLTs during the DLT observation period.
Occurrence of TEAEs and treatment-related AEs and deaths
Occurrence of TEAEs and treatment-related AEs and deaths.
Occurrence of abnormalities (Grade >= 3) in laboratory test values
Occurrence of abnormalities (Grade >= 3) in laboratory test values.
Occurrence of markedly abnormal vital sign measurements
Occurrence of markedly abnormal vital sign measurements.
Occurrence of clinically significant abnormal ECGs
Occurrence of clinically significant abnormal ECGs.
PK data for identifying the local RDE in Japanese participants
In addition to the safety profile, PK data will be used for identifying the local RDE in Japanese participants.
Objective response (confirmed CR or PR) by RECIST Version 1.1
Objective response (confirmed CR or PR) by RECIST Version 1.1.
次要结局
未报告次要终点
研究者
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