[Translation] An open-label, dose-escalation and dose-expansion Phase I/II clinical study of the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of the kinase inhibitor LM-061 tablets in patients with advanced solid tumors
I期剂量递增
主要目的: 1)评估LM-061片剂在晚期实体瘤患者中的安全性和耐受性; 2)确定LM-061片剂在晚期实体瘤患者中的剂量限制性毒性(DLT)和最大耐受剂量(MTD); 3)确定II期推荐剂量(RP2D)。
次要目的:
1)评估LM-061片剂在晚期实体瘤患者中的药代动力学特征;
2)评估LM-061片剂在晚期实体瘤患者中的初步抗肿瘤活性;
II期剂量扩展
主要目的:
评估LM-061片剂在c-MET异常的EGFR-TKI耐药的非小细胞肺癌、肺肉瘤样腺癌、乳头状肾细胞癌、转移或局部晚期不可切的胃腺癌等患者中的抗肿瘤活性;
次要目的:
1)评估LM-061片剂在c-MET异常的EGFR-TKI耐药的非小细胞肺癌、肺肉瘤样腺癌、乳头状肾细胞癌、转移或局部晚期不可切的胃腺癌等患者中的安全性和耐受性;
2)评估LM-061片剂在c-MET异常的EGFR-TKI耐药的非小细胞肺癌、肺肉瘤样腺癌、乳头状肾细胞癌、转移或局部晚期不可切的胃腺癌等患者中的药代动力学特征。
[Translation] Phase I dose escalation
Main objectives: 1) Evaluate the safety and tolerability of LM-061 tablets in patients with advanced solid tumors; 2) Determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of LM-061 tablets in patients with advanced solid tumors; 3) Determine the Phase II recommended dose (RP2D).
Secondary objectives:
1) Evaluate the pharmacokinetic characteristics of LM-061 tablets in patients with advanced solid tumors;
2) Evaluate the preliminary antitumor activity of LM-061 tablets in patients with advanced solid tumors;
Phase II dose expansion
Primary objectives:
Evaluate the antitumor activity of LM-061 tablets in patients with c-MET abnormal EGFR-TKI-resistant non-small cell lung cancer, pulmonary sarcomatoid adenocarcinoma, papillary renal cell carcinoma, metastatic or locally advanced unresectable gastric adenocarcinoma, etc.;
Secondary objectives:
1) Evaluate the safety and tolerability of LM-061 tablets in patients with c-MET abnormal EGFR-TKI-resistant non-small cell lung cancer, pulmonary sarcomatoid adenocarcinoma, papillary renal cell carcinoma, metastatic or locally advanced unresectable gastric adenocarcinoma, etc.;
2) Evaluate the pharmacokinetic characteristics of LM-061 tablets in patients with c-MET abnormal EGFR-TKI-resistant non-small cell lung cancer, pulmonary sarcomatoid adenocarcinoma, papillary renal cell carcinoma, metastatic or locally advanced unresectable gastric adenocarcinoma, etc.