NCT05712889已完成1 期
An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity and Pharmacokinetics of VIP236 Monotherapy in Subjects With Advanced Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 6
- 主要终点
- Incidence of DLT (Dose limit toxicity) of VIP236
研究概览
简要总结
Determine the safety, tolerability, and maximum tolerated dose (MTD) of IV administered VIP236 as monotherapy in patients with advanced solid tumor cancer
详细描述
Solid tumor subjects with histologically confirmed advanced or metastatic disease who have relapsed or refractory to standard of care. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.
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
- •Adult patients aged >/=18 years, able to provide informed consent and willing to comply with all study procedures.
- •Histologically confirmed advanced or metastatic solid tumors that are relapsed or refractory to standard of care. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies. Refer to NCCN guidelines of each respective histology for guidance. Starting with Amendment 3, this study will focus enrollment on the following cancers:
- •Biliary tract cancers Breast cancer Cervical cancer Endometrial carcinoma Gastric cancer/gastroesophageal junction adenocarcinoma Nonsmall cell lung cancer Ovarian cancer/fallopian tube cancer/primary peritoneal cancer Pancreatic adenocarcinoma Small cell lung cancer Urothelial cancer
- •Adequate bone marrow, liver, and renal functions.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
排除标准
- •Subjects who have new or progressive brain or meningeal or spinal metastases.
- •Clinically significant cardiac disease including congestive heart failure > New York Heart Association (NYHA) Class II), evidence for coronary artery disease (eg, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose.
- •Major surgery or significant trauma within 4 weeks before the first dose of study drug.
- •Medical history of chronic obstructive pulmonary disease (COPD) and other respiratory disorders.
研究组 & 干预措施
Dose Escalation of VIP236 (Q3W)
Experimental
Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer. Dosing occurs on D1 of each 21-day cycle
干预措施: VIP236 (Q3W) (Drug)
Dose Escalation of VIP236 (Q2W)
Experimental
Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer. Dosing occurs on D1 and D15 of each 28-day cycle.
干预措施: VIP236 (Q2W) (Drug)
结局指标
主要结局
Incidence of DLT (Dose limit toxicity) of VIP236
时间窗: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
Number of participants with adverse events as a measure safety and tolerability
时间窗: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months)
次要结局
- Objective response rate (ORR), defined as the proportions of subjects who have a best overall response of partial response (PR) or complete response (CR) as determined by investigators using RECIST 1.1(Up to 24 onths)
- Disease control rate (DCR) per RECIST v1.1, defined as best overall response of complete response (CR), partial response (PR), or stable disease (SD) as determined by Investigator review.(Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months))
- Progression-free survival per RECIST v1.1, defined as the time from enrollment to documented disease progression or death from any cause, whichever occurs earlier as determined by Investigator review(Up to 24 months)
- Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP236(Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days)
- Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP236(Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days)
研究者
研究点 (6)
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