NCT07612176招募中1 期
A Phase 1 Dose Escalation and Expansion Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific Antibody-Drug Conjugate, in Participants With Select, Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors
NEOK Bio, Inc.15 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2026年4月21日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 155
- 试验地点
- 15
研究概览
简要总结
This is a first in human (FIH), Phase 1, dose escalation and expansion study in select solid tumors. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B).
详细描述
This is a FIH, Phase 1, open-label, multicenter, multiple-dose, dose escalation and expansion study. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B). NEOK001 is a bispecific B7-H3 x ROR1 exatecan antibody-drug conjugate (ADC) that will be administered intravenously once every cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Participants must have locally advanced or metastatic disease in a select tumor type, for which no standard therapy is available.
- •Participants must have at least 1 measurable target lesion based on RECIST v1.
- •Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Participants must have adequate hematologic, hepatic, and renal function.
- •Participants should have available archived tumor tissue from their most recent biopsy.
排除标准
- •Participant's most recent systemic anti-cancer treatment was an ADC with a topoisomerase 1-inhibitor payload component.
- •Participants with known symptomatic central nervous system (CNS) metastases or any evidence of leptomeningeal disease or evidence of unstable CNS metastases, even if asymptomatic.
- •Participants with a known history of interstitial lung disease (ILD) requiring steroid treatment, or for whom suspected ILD cannot be ruled out by imaging at screening.
- •Participants with clinically severe pulmonary compromise due to intercurrent pulmonary illness and/or pulmonary disorder requiring supplemental oxygen or any prior pneumonectomy.
- •Participants with a QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec.
研究组 & 干预措施
Expansion
Experimental
干预措施: NEOK001 RDE (Drug)
Dose Escalation
Experimental
干预措施: NEOK001 (Drug)
研究者
研究点 (15)
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