A Phase 1 Study of LY3127804 as Monotherapy and in Combination With Ramucirumab in Patients With Advanced Solid Tumors

Eli Lilly and Company3 个研究点分布在 2 个国家目标入组 62 人开始时间: 2015年11月6日最近更新: 2025年10月23日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方: Eli Lilly and Company
入组人数: 62
试验地点: 3
主要终点: Recommended Phase 2 Dose of LY3127804 Monotherapy and in Combination With Ramucirumab

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main purpose of this study is to evaluate the safety of the study drug known as LY3127804 given as monotherapy and in combination with Ramucirumab for participants with advanced or metastatic solid tumors. The study will also include a safety exploration for the combination of LY3127804 plus ramucirumab and paclitaxel

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
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

•Have a diagnosis of cancer that is advanced and/or metastatic.
•Have disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST ) version 1.
•Have adequate organ function.
•Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•Have discontinued previous treatments for cancer for at least 28 days or 5 half-lives prior to study enrolment.

排除标准

•Have serious preexisting medical conditions.
•Have received treatment with a drug predominantly targeting Ang2 activity.
•Have symptomatic central nervous system (CNS) malignancy or metastasis.
•Have current hematologic malignancies.
•Have an active fungal, bacterial, and/or known viral infection.
•Have a corrected QT interval using Fridericia's correction (QTcF) of >470 msec on screening electrocardiogram (ECG) at several consecutive days of assessment.
•Have a known sensitivity to mAbs or other therapeutic proteins.
•Have a history of hypertensive crisis or hypertensive encephalopathy or current poorly controlled hypertension despite standard medical management.
•Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 3 months prior to receiving treatment.
•Receive anticoagulation therapy at therapeutic dose.
•Have experienced any arterial or venothrombotic or thromboembolic events within 6 months prior to study treatment.
•Have liver cirrhosis with a Child-Pugh class B or worse or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
•The participant is pregnant prior to randomization or breastfeeding.
•The participant has sensory peripheral neuropathy ≥ Grade 2 (Part E only).

研究组 & 干预措施

Part A LY3127804

Experimental

Participants received escalating doses of 4 milligram per kilogram (mg/kg), 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg and 27 mg/kg LY3127804 administered as intravenous (IV) infusion on days 1 and 15 of a 28-day cycle.

干预措施: LY3127804 (Drug)

Part B LY3127804 + 8 mg/kg Ramucirumab

Experimental

Participants received escalating doses of 8 mg/kg / 12 mg/kg / 16 mg/kg / 20 mg/kg / 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.

干预措施: LY3127804 (Drug)

Part B LY3127804 + 8 mg/kg Ramucirumab

Experimental

Participants received escalating doses of 8 mg/kg / 12 mg/kg / 16 mg/kg / 20 mg/kg / 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.

干预措施: Ramucirumab (Drug)

Part C LY3127804 + 12 mg/kg Ramucirumab

Experimental

Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.

干预措施: LY3127804 (Drug)

Part C LY3127804 + 12 mg/kg Ramucirumab

Experimental

Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.

干预措施: Ramucirumab (Drug)

Part D LY3127804 + Ramucirumab - Not Enrolled

Experimental

Participants were to receive LY3127804 and Ramucirumab IV Q2W until participant qualifies for study discontinuation.