Shanghai LaNova Medicines Research and Development Co Ltd

The main purpose of the Phase I dose escalation phase is to evaluate the safety and tolerability of LM-108 alone or in combination with toripalimab in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and/or Phase II recommended dose (RP2D). Secondary objectives are to evaluate the pharmacokinetic (PK) characteristics of LM-108 alone or in combination with toripalimab; to evaluate the immunogenicity of LM-108; to evaluate the preliminary anti-tumor activity of LM-108 alone or in combination with toripalimab; and to evaluate the correlation between biomarker expression levels and the anti-tumor activity of LM-108 alone or in combination with toripalimab. The main purpose of the Phase II dose expansion phase is to evaluate the objective response (ORR) of LM-108 alone or in combination with toripalimab in patients with advanced solid tumors. Secondary objectives: To evaluate the duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) of LM-108 alone or in combination with toripalimab in patients with advanced solid tumors; to evaluate the safety and tolerability of LM-108 alone or in combination with toripalimab in patients with advanced solid tumors; to evaluate the pharmacokinetic characteristics of LM-108 alone or in combination with toripalimab in patients with advanced solid tumors; to evaluate the immunogenicity of LM-108; and to evaluate the correlation between biomarker expression levels and the anti-tumor activity of LM-108 alone or in combination with toripalimab.

To evaluate the safety and tolerability of LM-102 in patients with advanced solid tumors, explore the recommended Phase II dose (RP2D) and/or determine the maximum tolerated dose (MTD).

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.