NCT05103046招募中1 期
A Phase 1, First in Human, Dose-Escalation Study of UCT-03-008 in Participants With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 5
- 主要终点
- Recommended Phase 2 Dose (RP2D)
研究概览
简要总结
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-03-008 in patients with advanced 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
- •Advanced solid tumor
- •Measurable disease, per RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Adequate organ function
排除标准
- •Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
- •Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of UCT-03-008
- •Progressive or symptomatic brain metastases
- •Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
- •History of significant cardiac disease
- •History or current evidence/risk of retinopathy
- •History of myelodysplastic syndrome (MDS) or AML
- •History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
- •If female, is pregnant or breastfeeding
研究组 & 干预措施
Dose Finding as Monotherapy - Part 1
Experimental
UCT-03-008 Dose Finding
干预措施: UCT-03-008 (Drug)
Expansion as Monotherapy - Part 2
Experimental
UCT-03-008 RP2D Expansion
干预措施: UCT-03-008 (Drug)
结局指标
主要结局
Recommended Phase 2 Dose (RP2D)
时间窗: up to 2 years
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Maximum Tolerated Dose (MTD)
时间窗: 28 Days
Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Incidence and severity of adverse events and serious adverse events
时间窗: up to 2 years
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
次要结局
- Maximum Plasma UCT-03-008 Concentration following single dose (Cmax)(Cycle 0(each cycle is 28 days))
- Time of Maximum Plasma UCT-03-008 Concentration following single dose (Tmax)(Cycle 0 (each cycle is 28 days))
- Apparent Clearance (CL/F) of UCT-03-008(Cycle 0 (each cycle is 28 days))
- Apparent Volume of Distribution (Vz/F) of UCT-03-008(Cycle 0 (each cycle is 28 days))
- Minimum Plasma UCT-03-008 Concentration following single dose (Cmin)(Cycle 0 (each cycle is 28 days))
- Area Under the Plasma Concentration-Time Curve from the time of dosing to the last measurable concentration (AUClast) of UCT-03-008(Cycle 0 (each cycle is 28 days))
- Terminal Half-life (t1/2) of plasma UCT-03-008(Cycle 1 (each cycle is 28 days))
- 2 Year Overall Survival (2YOS)(2 years)
- Minimum Plasma UCT-03-008 Concentration at steady state (Cmin,ss)(Cycle 1 (each cycle is 28 days))
- Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of UCT-03-008(Cycle 0 (each cycle is 28 days))
- Maximum Plasma UCT-03-008 Concentration at steady state (Cmax,ss)(Cycle 1 (each cycle is 28 days))
- Time of Maximum Plasma UCT-03-008 Concentration at steady state (Tmax,ss)(Cycle 0 (each cycle is 28 days))
- Objective Response Rate (ORR)(up to 2 years)
- Time to Response (TTR)(up to 2 years)
- Duration of Response (DOR)(up to 2 years)
- Progression Free Survival (PFS)(up to 2 years)
- 1 Year Overall Survival (1YOS)(1 year)
研究者
研究点 (5)
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