An Open label, Multicenter, Phase 1b/2a Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of the ATR inhibitor M1774 in Combination with Cemiplimab in Participants with Non-Squamous Non-Small Cell Lung Cancer that has Progressed on Prior Anti-PD-(L)1 and Platinum-based Therapies

Ishii Kyoko0 个研究点目标入组 25 人开始时间: 2023年9月7日最近更新: 2024年4月23日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 25

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 18age old 至 ot applicable（—）
性别: All

入选标准

•Are diagnosed with nsqNSCLC histologically or cytologically confirmed
•-Radiologically confirmed/documented disease progression during or after the following systemic therapies
•-Measurable disease per RECIST v1.1, as assessed by the Investigator
•-ECOG PS 0 or 1
•-Adequate hematologic function
•-Adequate hepatic function
•-Adequate renal function
•-Archival FFPE tumor tissue is required
•-Phase 2a part only: central liquid biopsy analysis of tumor molecular alterations with an assay with appropriate regulatory status. Participants will be allocated to 1 of the strata as follows:
•- STK11 and/or KEAP1 loss of function mutation: Stratum A
•- ATM, ARID1A, SMARCA4, or PBRM1 loss of function mutation: Stratum B
•- Other or nonidentified alterations: Stratum C
•- Other protocol defined inclusion criteria could apply

排除标准

•- Participants with tumors harboring actionable EGFR or ALK genomic aberrations as determined by local assessment with assays of appropriate regulatory status
•- History of additional malignancy within 3 years before the date of enrollment
•- Known brain metastase
•- Active and/or uncontrolled infection
•- Organ transplantation, including allogeneic stem cell transplant
•- Uncontrolled or poorly controlled arterial hypertension, symptomatic congestive heart failure (New York Heart Association Classification >= Class III), uncontrolled cardiac arrhythmia, calculated QTc average using the QTcF > 470 msec; unstable angina pectoris, myocardial infarction or a coronary revascularization procedure, cerebral vascular accident, transient ischemic attack, or any other significant vascular disease within 180 days of study intervention start
•- History of (noninfectious) pneumonitis that required systemic corticosteroids or current pneumonitis/interstitial lung disease
•- Any other clinical condition, uncontrolled concurrent illness, or other situations, which in the Investigator's opinion would not make the patient a good candidate for the study or may potentially impact the absorption of M1774 such as (but not limited to) significant small bowel resection, gastric surgery, or exocrine pancreatic insufficiency requiring pancreatic enzyme replacement therapy
•- Prior use of ATR, CHK1, and WEE1 inhibitors
•- Prohibited concomitant therapy
•- Live vaccines within 4 weeks of first dose of study intervention and while receiving study intervention
•- Active or history of autoimmune disease that has required chronic systemic immunosuppressive therapy (including but not limited to corticosteroids [e.g. prednisone > 10 mg/day] or equivalent), that might deteriorate when receiving immunostimulatory agent, or history of irAE Grade >= 3 or any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 therapy.
•- Participants who received prior chemotherapy, biological therapy (e.g. antibodies) or systemic immunostimulatory agents (e.g. interferon and interleukin 2) within 4 weeks (6 weeks for nitrosurea, mitomycin-C), or who have been treated with small molecule therapeutics or any investigational agents within 4 weeks prior to starting study interventions, or within 5 half-lives, whichever is shorter
•- Prior radiotherapy within 14 days before the first dose of study intervention or prior lung radiotherapy of > 30 Gy within 12 weeks before the first dose of study intervention
•- Persistence of AEs related to any prior treatments that have not recovered to Grade <= 1
•- Other protocol defined exclusion criteria could apply.

研究者

发起方

Ishii Kyoko

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