A Study of NEOK002, an EGFR and MUC1 Targeting Bispecific Antibody-Drug, Conjugate in Participants With Select Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors
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
- 10
- 主要终点
- Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs)
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 EGFR and MUC1 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 metatstatic 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.
- •Participant 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
Dose Escalation
NEOK002
干预措施: NEOK002 (Drug)
Dose Expansion
Recommended Dose of NEOK002 for Expansion
干预措施: NEOK002 RDE (Drug)
结局指标
主要结局
Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs)
时间窗: 21 days
Incidence and severity of DLTs during the first cycle of treatment in Part A
Part A: Incidence and Severity of Adverse Events (AEs)
时间窗: Through study completion, estimated as 32 months
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients in Part A
Part B: Investigator Assessment of Objective Response Rate (ORR)
时间窗: Through study completion, estimated as 32 months
Percentage of patients who achieve a confirmed objective response (ORR)
Part B: Duration of Response (DOR)
时间窗: Through study completion, estimated as 32 months
The time from the first documentation of tumor response (complete or partial) until disease progression or death.
次要结局
- Maximum Concentration (Cmax) of NEOK002(21 days)
- Part B: Incidence of AEs(Through study completion, estimated as 32 months)
- Terminal Elimination Half Life (T1/2) of NEOK002(21 days)