NCT04761601终止1 期
A Phase 1, First in Human, Dose-Escalation Study of UCT-01-097 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
- 终止
- 入组人数
- 32
- 试验地点
- 6
- 主要终点
- Incidence and severity of adverse events and serious adverse events
研究概览
简要总结
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-01-097 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-01-097
- •Progressive or symptomatic brain metastases
- •Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
- •History of phosphate or calcium disorder
- •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 in Combination - Part 3
Experimental
干预措施: Gemcitabine (Drug)
Dose Finding as Monotherapy - Part 1
Experimental
干预措施: UCT-01-097 (Drug)
Expansion as Monotherapy - Part 2
Experimental
干预措施: UCT-01-097 (Drug)
Dose Finding in Combination - Part 3
Experimental
干预措施: UCT-01-097 (Drug)
Dose Finding in Combination - Part 3
Experimental
干预措施: Paclitaxel (Drug)
结局指标
主要结局
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
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
Recommended Phase 2 Dose (RP2D)
时间窗: up to 2 years
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
次要结局
- Maximum Plasma UCT-01-097 Concentration (Cmax)(Day 1)
- Maximum Plasma UCT-01-097 Concentration at steady state (Cmax,ss)(Day 15)
- Apparent Clearance (CL/F) of UCT-01-097(Cycle 1 (each cycle is 28 days))
- Duration of Response (DOR)(up to 2 years)
- Progression Free Survival (PFS)(up to 2 years)
- Apparent Volume of Distribution (Vz/F) of UCT-01-097(Cycle 1 (each cycle is 28 days))
- UCT-01-097 Trough Plasma Concentration (Cmin)(Day 1)
- UCT-01-097 Trough Plasma Concentration at Steady State (Cmin,ss)(Day 15)
- Time of Maximum Plasma UCT-01-097 Concentration (Tmax)(Cycle 1 (each cycle is 28 days))
- Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of UCT-01-097(Day 15)
- Accumulation Ratio (Rac) of UCT-01-097(Cycle 1 (each cycle is 28 days))
- Terminal Half-life (t1/2) of UCT-01-097(Cycle 1 (each cycle is 28 days))
- Objective Response Rate (ORR)(up to 2 years)
- Time to Response (TTR)(up to 2 years)
- 1 Year Overall Survival (1YOS)(1 year)
- 2 Year Overall Survival (2YOS)(2 years)
研究者
研究点 (6)
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