an Open-Label, Phase 1/2a, First-in-Human Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria
研究概览
简要总结
This study is an Open-Label, Phase 1/2a, First-in-Human, Dose-Escalation, Dose-Expansion, and Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors.
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
- •Aged 18 and older.
- •Capable of giving signed informed consent.
- •Diagnosed with particular disease characteristics.
- •Expected survival ≥ 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •A female patient is eligible to participate if she is not pregnant or breastfeeding.
- •A male patient is eligible to participate if he agrees to remain abstinent or use a male condom when having sexual intercourse with a WOCBP, or if he has had a bilateral vasectomy.
- •Have measurable disease by revised RECIST v1.1 criteria.
排除标准
- •Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption.
- •Current enrollment or past participation in another clinical trial.
- •Unresolved adverse reactions (except alopecia) from previous cancer-directed therapy.
- •Use of cancer-directed therapies, including chimeric antigen receptor T cell therapy.
- •Autologous transplantation within 60 days.
- •Prior allogeneic transplantation.
- •Major surgery within 30 days, or unresolved complications after a major or minor surgery.
- •History of or currently active cardiovascular disease.
- •Clinically significant respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
- •History of other malignancy.
研究组 & 干预措施
Monotherapy
Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Pharmacodynamic Biomarkers
干预措施: DA-4505 (Drug)
Combination with Pembrolizumab
Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Proof of concept Phase 2a: Pharmacodynamic Biomarkers
干预措施: DA-4505 + Pembrolizumab (Drug)
结局指标
主要结局
Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria
时间窗: Cycle 1(21 days) in dose escalation
The recommended Phase 2 dose(RP2D) will be the optimal biological dose (OBD) based on consideration of safety and tolerability information along with all available pharmacokinetic (PK), pharmacodynamic (PD), and efficacy data.
PK parameters for DA-4505 (half-life (t1/2))
时间窗: Day 1 and 2 of first 2 cycles (every 21 days)
Determine DA-4505 half-life (t1/2).
PK parameters for DA-4505 (Area Under the Curve (AUC))
时间窗: Day 1 and 2 of first 2 cycles (every 21 days)
Determine DA-4505 AUC
Response per revised "Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1)
时间窗: approximately 12 months
To determine the anti-tumor activity of both DA-4505 as a single agent and in combination with pembrolizumab
PK parameters for DA-4505 (Peak Plasma Concentration (Cmax))
时间窗: Day 1 and 2 of first 2 cycles (every 21 days)
Determine DA-4505 Cmax
次要结局
未报告次要终点