JPRN-jRCT2031230098招募中1 期
An Open-Label, Multicenter Study of LOXO-435 (LY3866288) In Advanced Solid Tumor Malignancies With FGFR3 Alterations - LOXO-FG3-22001
Masaki Takeshi0 个研究点目标入组 140 人开始时间: 2023年5月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
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
- •Have solid tumor cancer with an FGFR3 pathway alteration on molecular testing in tumor or blood sample that is deemed as actionable.
- •Cohort A (Dose Escalation): Presence of an alteration in FGFR3 or its ligands deemed as a clinically or potentially clinically relevant alteration by the treating Investigator.
- •Cohorts B1, B2 and B3 (Dose Expansion): Histological diagnosis of urothelial cancer that is locally advanced or metastatic with a prespecified activating FGFR3 alteration.
- •Cohort C (Dose Expansion): Must have histological diagnosis of a non-urothelial solid tumor malignancy that is locally advanced or metastatic with a prespecified activating FGFR3 alteration.
- •Measurability of disease:
- •Phase 1a: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v1.1)
- •Phase 1b: Measurable disease required as defined by RECIST v1.1
- •Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country-specific regulations.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •Patient has received all standard therapies for which the patient was deemed to be an appropriate candidate by the treating Investigator; OR the patient is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies.
- •Cohort B1: Patients must have been previously treated with a FGFR inhibitor.
- •Cohort B2, B3, C1: Patients must be FGFR inhibitor naive.
排除标准
- •Patients with primary central nervous system (CNS) malignancy
- •Known or suspected history of uncontrolled CNS metastases
- •Current evidence of corneal keratopathy or retinal disorder
- •Have a history and/or current evidence of extensive tissue calcification
- •Any serious unresolved toxicities from prior therapy
- •Significant cardiovascular disease
- •Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF)
- •Active uncontrolled systemic infection or other clinically significant medical conditions
- •Patients who are pregnant, lactating, or plan to breastfeed during the study or within 6 months of the last dose of study treatment
研究者
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