A Phase Ⅱ, Multicenter Open-label Study to Investigate the Efficacy and Safety of HL-085 Combined With Vemurafenib in Patients With Metastatic Colorectal Cancer (mCRC)

Shanghai Kechow Pharma, Inc.1 个研究点分布在 1 个国家目标入组 186 人开始时间: 2022年2月24日最近更新: 2023年5月31日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方: Shanghai Kechow Pharma, Inc.
入组人数: 186
试验地点: 1
主要终点: ORR（by investigator）

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 study consists of the two parts, phase IIa and phase IIb.

详细描述

The study consists of the two parts, phase IIa and phase IIb. Phase IIa study is to assess the safety and the antitumor activity in patients with mCRC and to recommend reasonable dosage regimen of HL-085 for phase IIb study. Phase IIb is a pivotal study to evaluate HL-085 plus Vemurafenib in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting.

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 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Signed written informed consent prior to enrollment；
•Adults 18 years of age or older, male or female;
•Histologically- or cytologically-confirmed CRC that is metastatic disease, and a) progression of disease or intolerance after line 1 or line 2 therapy，or inappropriate for line 1 therapy (for phase Ⅱa); b) progression of disease or intolerance after line 1 or line 2 therapy (for phase Ⅱb);
•Patient must have measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1);
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
•Life expectancy ≥ 3 months;
•Able to take the medicine orally;
•Adequate bone marrow and organ function.

排除标准

•Prior treatment with any RAS inhibitors, RAF inhibitors, or MEK inhibitors;
•History or screening evidence of retinal diseases;
•Impaired cardiovascular function or clinically significant cardiovascular and cerebrovascular diseases;
•Previous or current neuromuscular diseases that is associated with CK elevation (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, rhabdomyolysis syndrome);
•Impaired liver function, defined as Child-Pugh Class B or C;
•Toxicity has not recovered to grade 0 or 1 from prior anticancer therapy (except for alopecia, pigmentation, and grade 2 chemotherapy-related neurotoxicity);
•Use of any medications or foods that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4/5 within 7 days prior to the start of study treatment or during the study period, , drugs with a narrow therapeutic window for CYP1A2 metabolism.

研究组 & 干预措施

phase IIa: HL-085 in Subjects With BRAF V600E-Mutated CRC

Experimental

12mg BID HL-085

干预措施: HL-085 (Drug)