For Phase I, to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-364 as a single agent or in combination with tislelizumab in participants with advanced solid tumors.
For Phase II, to assess the preliminary anti-tumor activity of IMP in participants with advanced solid tumors.
Participants who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
Participants must be ≥18 years or the legal age of consent at the time of signing the ICF.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Life expectancy ≥ 3 months.
Participant in any other clinical trial within 28 days prior to 1st dosing of LM-364.
Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v6.0.
Participants with uncontrolled tumour-related pain.
Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-364.
Sequential
LM-364 for injection
DrugQ3W, Intravenous Drip
Tislelizumab
DrugQ3W, Intravenous Drip
Incidence of dose-limiting toxicity (DLT)
Phase I
Incidence of Treatment-Emergent Adverse Events (AEs)
Phase I
Incidence of serious adverse events (SAEs)
Phase I
Temperature (Celsius)
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
PK Parameter: Steady State Maximum Concentration (Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Phase I/II
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