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)

Yamaki Masataka0 个研究点目标入组 17 人开始时间: 2022年9月8日最近更新: 2023年10月17日

试验速览

暂无简介。

•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 1.1.
•-Adequate hematologic function
•-Adequate hepatic function
•-Adequate renal function
•-Other protocol defined inclusion criteria could apply

•- 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.

发起方

Yamaki Masataka