jRCT2051240129招募中不适用
An Open-label, Multicenter Study of LY4050784, a Selective SMARCA2/BRM Inhibitor, in Advanced Solid Tumor Malignancies With SMARCA4/BRG1 Alterations (J5M-OX-JOXA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 主要终点
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs)
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
- Non-randomized Controlled Trial
- 干预模型
- Parallel 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
- •Have one of the following locally advanced or metastatic solid tumor malignancy with BRG1/SMARCA4 alteration:
- •Phase 1a dose escalation: Presence of any alteration in SMARCA4/BRG1
- •Phase 1b expansion: Part A: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4/BRG1 or loss of protein expression.
- •Phase 1b expansion: Part B: Any tumor type (other than NSCLC) that has the presence of a known or likely loss of function alteration in SMARCA4/BRG1 or loss of protein expression.
- •Prior Systemic Therapy Criteria:
- •Phase 1a dose escalation and Phase 1b (Part B): Participants who received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating Investigator; or the individual is refusing the remaining most appropriate standard of care treatment; or there is no standard therapy available for the disease.
- •Phase 1b expansion (Part A): Participants must have received at least one line of therapy for advanced or metastatic disease.
- •Measurability of disease
- •Phase 1a dose escalation (excluding backfill): measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
- •Phase 1a backfill and Phase 1b expansion: Measurable disease required as defined by RECIST v1.1
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
排除标准
- •Participants with known loss of function alteration of SMARCA2/BRM or malignancy with known association with SMARCA2/BRM alterations
- •Prior exposure to SMARCA2/BRM inhibitor(s) and/or degrader(s) (prior exposure may be permitted for dose escalation)
- •Participants with known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement
- •Participants with history of increased risk of prolonged QT or significant arrythmia
- •Significant cardiovascular disease
- •Participants with active or recently treated (within 2 years) second primary malignancy and/or treated for an additional malignancy within 2 years prior to enrolment
- •Participants who are pregnant, breastfeeding or plan to breastfeed or expecting to conceive or father children during study or within 6 months after the last dose of study intervention
结局指标
主要结局
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to Approximately 48 Months or 4 Years
A summary of TEAEs regardless of causality, will be reported in the Reported Adverse Events module
Number of Participants with Serious Adverse Event(s) (SAEs)
时间窗: Up to Approximately 48 Months or 4 Years
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Number of Participants with Adverse Event(s) (AEs)
时间窗: Up to Approximately 48 Months or 4 Years
A summary of AEs regardless of causality, will be reported in the Reported Adverse Events module
次要结局
未报告次要终点
研究者
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