A Multicenter Phase 1, Open-Label Study of DCC-2618 to Assess Safety, Tolerability, Efficacy, and Pharmacokinetics in Patients With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 26
- 主要终点
- Safety/tolerability of oral DCC-2618: incidence of adverse events
研究概览
简要总结
This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with advanced malignancies. The study consists of 2 parts, a dose-escalation phase, and an expansion phase. All active patients (from both dose-escalation and expansion phases) will then transition into an extension phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Escalation
Escalation Phase: DCC-2618 tablets in escalating dose cohorts given orally BID (twice daily) every 12 hours or once daily (QD) for repeated 28-day cycles. Participants may continue to receive study drug until discontinuation criteria are met. [Closed for Enrollment]
干预措施: DCC-2618 (Drug)
Expansion Cohort 1
150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with GIST who have received 3 prior therapies. [Closed for Enrollment]
干预措施: DCC-2618 (Drug)
Expansion Cohort 2
150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with GIST who have received 4 prior therapies. [Closed for Enrollment]
干预措施: DCC-2618 (Drug)
Expansion Cohort 3
150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with GIST who have received at least one prior therapy and no more than 2 prior therapies. [Closed for Enrollment]
干预措施: DCC-2618 (Drug)
Expansion Cohort 4
150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with systemic mastocytosis and other hematologic malignancies.[Closed for Enrollment]
干预措施: DCC-2618 (Drug)
Expansion Cohort 5
150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with malignant gliomas.[Closed for Enrollment]
干预措施: DCC-2618 (Drug)
Expansion Cohort 6
150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with other solid tumors. [Closed for Enrollment]
干预措施: DCC-2618 (Drug)
Expansion Cohort 7
150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with melanomas. [Closed for Enrollment]
干预措施: DCC-2618 (Drug)
Expansion Cohort 8
150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with soft tissue sarcomas.[Closed for Enrollment]
干预措施: DCC-2618 (Drug)
Expansion Cohort 9
150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with germ cell, penile cancer and non-small cell lung carcinoma (NSCLC). [Closed for Enrollment]
干预措施: DCC-2618 (Drug)
Expansion Cohort 10
150 mg DCC-2618 given once daily in repeated 28-day cycles in patients with GIST and other solid tumors with renal impairment. [Closed for Enrollment]
干预措施: DCC-2618 (Drug)
Extension Cohort
150 mg DCC-2618 given once daily in repeated 28-day cycles for active patients from the Escalation and Extension Phases.
干预措施: DCC-2618 (Drug)
结局指标
主要结局
Safety/tolerability of oral DCC-2618: incidence of adverse events
时间窗: Approximately 24 months
Dose limiting toxicities, AEs, SAEs, discontinuation of drug due to toxicity, physical exams and ECOG PS, ophthalmologic examinations, changes from baseline in laboratory parameters, electrocardiograms, LVEF, and vital signs.
Determination of the Maximum Tolerated Dose and the Recommended Phase 2 Dose
时间窗: 18 months
Expansion Phase: Assess Antitumor Activity of DCC-2618 in all diseases
时间窗: Approximately 24 months
Objective response rate (ORR); Disease control rate (DCR)
次要结局
- Determine the PK profile of oral DCC-2618(Predose and up to 24 hours postdose (Cycle = 28 Days))
- Escalation Phase: Assess Antitumor Activity of DCC-2618 in patients with advanced malignancies(Approximately 24 months)