NCT07423117
尚未招募
1 期
A Phase 1a/b, Open-label, Multicenter, First-in-human, Dose Escalation/Expansion Study With Multiple Cohorts to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Efficacy of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy
IntoCell, Inc0 个研究点目标入组 102 人开始时间: 2026年2月6日最近更新:
干预措施ITC-6146RO
概览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- IntoCell, Inc
- 入组人数
- 102
- 主要终点
- Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs)
概览
简要总结
The study consists of Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, sequential cohorts of subjects will receive escalating doses of ITC-6146RO to determine maximum tolerated dose (MTD) and/or optimal biological dose (OBD).
In Phase 1b, the recommended phase 2 dose (RP2D) chosen from Phase 1a will be evaluated to further investigate safety, tolerability, pharmacokinetic (PK) and anti-tumor efficacy of ITC-6146RO.
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
- •Adult males and females aged ≥ 19 years (Korea) or ≥ 18 years (United States)
- •Patients must be individuals who have voluntarily agreed to participate in the study after receiving a detailed explanation and fully understanding the nature of the clinical trial, and who have provided written informed consent.
- •Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease
- •Patients must have at least one evaluable or measurable lesion based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1). However, for patients with prostate cancer, eligibility will be determined based on Prostate Cancer Working Group 3 (PCWG3)
- •Patients who have received standard therapies and have no remaining clinically available approved treatment options.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Estimated life expectancy of ≥ 3 months
排除标准
- •Inability to comply with study and follow-up procedures
- •Patients with a prior history of anticancer therapy before the first dose
- •History of another active malignancy within the past 3 years
- •Patients with central nervous system metastases, leptomeningeal disease, or spinal cord compression.
- •Patients who are currently participating in a clinical trial or have participated in a clinical trial involving a medical device or investigational product within 28 days prior to the first administration of ITC-6146RO
- •Has prior treatment with duocarmycin-containing agents
- •Pregnancy, lactation, or breastfeeding
- •Known Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV) infection with active disease exception of the following conditions.
- •Tuberculosis with active disease
- •Active infection necessitating systemic therapy
研究组 & 干预措施
Phase 1a/b
Experimental
The study consists of a Phase 1a dose-escalation part and a Phase 1b dose-expansion part.
干预措施: ITC-6146RO (Drug)
结局指标
主要结局
Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs)
时间窗: Through study completion (Up to 2 years)
Grade 3 and 4 AEs, Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Dose-limiting toxicities (DLTs) and AEs leading to discontinuation of study treatment, Evaluation of all-grade cardiac, renal, and pulmonary AEs , n, (%)
Phase 1b (Dose Expansion) Incidence of AEs
时间窗: Through study completion (Up to 2 years)
Grade 3 and 4 AEs, TEAEs, SAEs and AEs leading to discontinuation of study treatment, Evaluation of all-grade cardiac, renal, and pulmonary AEs, n, %
次要结局
- Phase 1a (Dose Escalation) Maximum Tolerated Dose (MTD) or Optimal Biological Dose (OBD) of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) After Single-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) After Single-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Maximum Observed Plasma Concentration (Cmax) After Single-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Terminal Elimination Half-life (t1/2) After Single-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Time to Maximum Observed Plasma Concentration (Tmax) After Single-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Apparent Clearance (CL) After Single-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Apparent Volume of Distribution (Vz) After Single-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) After Multiple-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Maximum Observed Plasma Concentration at Steady State (Cmax,ss) After Multiple-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Trough Plasma Concentration at Steady State (Ctrough,ss) After Multiple-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Average Plasma Concentration Over the Dosing Interval at Steady State (Cav,τ) After Multiple-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Terminal Elimination Half-life at Steady State (t1/2,ss) After Multiple-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) After Multiple-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Apparent Clearance at Steady State (CLss) After Multiple-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Apparent Volume of Distribution at Steady State (Vss) After Multiple-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Accumulation Ratio After Multiple-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Peak-to-Trough Fluctuation (PTF) After Multiple-Dose Administration of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a (Dose Escalation) Incidence of Anti-Drug Antibodies (ADAs) to ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1b (Dose Expansion) Population Pharmacokinetic (PopPK) Parameters of ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1b (Dose Expansion) Incidence of Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to ITC-6146RO(Through study completion (Up to 2 years))
- Phase 1a/b (Dose Escalation, Dose Expansion) Objective Response Rate (ORR) by Investigator per RECIST v1.1(Through study completion (Up to 2 years))
- Phase 1a/b (Dose Escalation, Dose Expansion) Duration of Response (DoR) by Investigator per RECIST v1.1(Through study completion (Up to 2 years))
- Phase 1a/b (Dose Escalation, Dose Expansion) Time to Response (TTR) by Investigator per RECIST v1.1(Through study completion (Up to 2 years))
- Phase 1a/b (Dose Escalation, Dose Expansion) Progression-Free Survival (PFS) by Investigator per RECIST v1.1(Through study completion (Up to 2 years))
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