For phase I ,this study is to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D) and/or Maximum Tolerated Dose (MTD) for LM-168 as a single agent or in combination with toripalimab in subjects with advanced solid tumours.
For phase II ,this study is to assess the preliminary anti-tumour activity of LM-168 as a single agent or in combination with toripalimab measured by objective response rate (ORR) in subjects with advanced solid tumours.
Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
Aged ≥18 years old (including boundary values) , male or female.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Life expectancy ≥ 3 months.
Participate in any other clinical trial within 28 days prior to 1st dosing of LM-168.
Having received prior anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 28 days of commencing treatment with LM-168 or experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
Subjects who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-168.
Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
Sequential
LM-168
DrugQ3W,Intravenous Drip
Toripalimab
DrugQ3W,Intravenous
Incidence of adverse events (AEs)
Phase I
Incidence of dose-limitingtoxicity (DLT)
Phase I
Incidence of serious adverse event (SAE)
Phase I
Temperature (Celsius)
Phase I
Objective Response Rate (ORR)
Phase I
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Phase I/II
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Phase I/II
PK Parameter: Area Under the Concentration-time Curve(AUC)
Phase I/II
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