NCT07498725招募中1 期
A Phase 1b-2, Open-Label, Dose-Escalation, Expansion and Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of LRK-4189 Alone and in Combination With mFOLFOX6 or FOLFIRI in Patients With Solid Tumors
LARKSPUR BIOSCIENCES, INC.3 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2026年7月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Evaluation of treatment-related adverse events and/or toxicity, presented by dose, regimen and tumor type
研究概览
简要总结
The goal of this clinical trial is to learn if investigational agent LRK-4189 works to treat solid tumors in adults, with a focus on colorectal cancer. It will also learn about the safety of drug LRK-4189.
The main questions it aims to answer are:
Is LRK-4189, administered alone or in combination with standard chemotherapy regimens, safe and tolerable in patients with solid tumors?
Participants will:
- Take investigational agent LRK-4189 alone or in combination with standard chemotherapy regimens every day for up to 3 years.
- Visit the clinic once every week for checkups and tests.
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
- •Willing and able to sign the study consent form and take part in all required study visits, tests, and procedures.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Have a locally advanced or metastatic cancer that cannot be removed with surgery and has gotten worse despite treatment.
- •Cancer can be measured on scans, such as CT or MRI.
- •Willing to have tumor biopsies, meaning small samples of your tumor will be collected during the study.
- •Heart rhythm test (ECG) shows a normal result within safe limits.
- •Blood test results at screening are within an acceptable and stable range.
- •If you are a woman, you are not able to become pregnant, or you agree not to become pregnant during the study and to use approved birth control methods.
- •If you are a man, you agree not to donate sperm during the study. If you have sex with a partner who could become pregnant, you agree to use approved birth control methods during the study.
排除标准
- •Unable to swallow the study medication or your body cannot absorb it.
- •Have had a serious allergic reaction to LRK-4189 or any of its ingredients.
- •Have needed a fluid drainage procedure from the chest or abdomen within the past 6 weeks.
- •Have active cancer in the brain or spinal fluid, or brain tumors that require steroid treatment.
- •Currently receiving another cancer treatment.
- •Have an active HIV, hepatitis B, or hepatitis C infection with detectable virus levels.
- •Have an active infection that requires treatment through a vein (IV).
- •Taking certain medications that strongly interact with the study drug and cannot stop them at least 14 days before starting the study.
- •Pregnant or breastfeeding or planning to become pregnant or father a child during the study.
- •Cannot safely receive the standard chemotherapy that would be used with this study.
研究组 & 干预措施
Part 2b expansion
Experimental
干预措施: Chemo (Drug)
Part 2b expansion
Experimental
干预措施: LRK-4189 expansion (Drug)
Part 3 optimization
Experimental
干预措施: LRK-4189 optimization (Drug)
Part 1/1b escalation
Experimental
干预措施: LRK-4189 escalation (Drug)
Part 2 expansion
Experimental
干预措施: LRK-4189 expansion (Drug)
结局指标
主要结局
Evaluation of treatment-related adverse events and/or toxicity, presented by dose, regimen and tumor type
时间窗: From enrollment to the end of the first treatment cycle (each cycle is 21 days)
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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