NCT07300241招募中1 期
An Open-Label, First-in-Human, Phase 1/2 Dose Escalation and Expansion Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Neomorph, Inc12 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 12
- 主要终点
- Frequency and severity of treatment emergent adverse events (TEAEs) of NEO-811 as a single agent.
研究概览
简要总结
The NEO-811-101 study is an open-label, first-in-human, Phase 1/2 dose escalation and expansion study testing NEO-811, an ARNT molecular glue degrader, in subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma. The study will test NEO-811 initially as a monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC).
- •Subjects must have progressed on or refused standard therapies.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or
- •Estimated life expectancy, in the judgment of the Investigator, of at least 12 weeks.
- •Formalin-fixed paraffin-embedded (FFPE) tumor tissue, newly obtained or archival, is mandatory for enrollment to the study.
- •Measurable disease as defined by RECIST v1.
- •Adequate hematologic, hepatic, and renal function defined as:
- •Hemoglobin ≥10 g/dL,
- •Absolute neutrophil count ≥1000 cells/µL,
- •Platelet count ≥100,000/µL,
- •AST and ALT ≤2.5 × ULN, or AST and ALT ≤5 × ULN for subjects with liver metastases,
- •Total bilirubin ≤1.5 × ULN,
- •Estimated glomerular filtration rate (eGFR) ≥60 mL/min.
- •Subject can swallow oral medications and does not have a condition that could impair the oral bioavailability of the study drug.
- •Other inclusion criteria per protocol.
排除标准
- •Non-clear cell predominant RCC histologic subtypes.
- •Leptomeningeal disease or symptomatic active CNS metastases with exceptions for asymptomatic treated CNS metastases per protocol.
- •Prior or concurrent malignancies with exceptions per protocol.
- •History of hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV infection.
- •Other exclusion criteria per protocol.
研究组 & 干预措施
Single agent NEO-811 dose escalation
Experimental
NEO-811
干预措施: NEO-811 (Drug)
结局指标
主要结局
Frequency and severity of treatment emergent adverse events (TEAEs) of NEO-811 as a single agent.
时间窗: Start of Cycle 1 until at least 30 days following the last dose of the last treatment cycle (each treatment cycle is 21 days).
TEAEs will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0.
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of NEO-811 as a single agent.
时间窗: Start of Cycle 1 until at least 30 days following the last dose of the last treatment cycle (each treatment cycle is 21 days).
The MTD and/or RP2D of NEO-811 as a single agent will be determined.
次要结局
- Maximum observed plasma concentration (Cmax) of NEO-811.(Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).)
- Trough observed plasma concentration (Ctrough) of NEO-811.(Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).)
- Time to Cmax (Tmax) of NEO-811.(Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).)
- Area under the concentration time curve (AUC) of NEO-811.(Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).)
- Maximum observed plasma concentration (Cmax) of NEO-811.(Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).)
- Trough observed plasma concentration (Ctrough) of NEO-811.(Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).)
- Time to Cmax (Tmax) of NEO-811.(Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).)
- Area under the concentration time curve (AUC) of NEO-811.(Start of Cycle 1 until Day 1 of last treatment cycle (each treatment cycle is 21 days).)
- Anti-tumor activity of NEO-811 as a single agent.(Start of Cycle 1 until documented disease progression or death, etc. (each treatment cycle is 21 days), estimated as 6-9 months.)
研究者
研究点 (12)
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