For Safety introduction phase,this study is to evaluate the safety and tolerability of LM-168 in combination with other anti-tumor treatment regimens in participants of advanced solid tumor trials, determine the maximum tolerated dose (MTD), and explore the recommended phase II dose (RP2D). For Dose expansion phase,this study is to evaluate the preliminary antitumor activity of LM-168 in combination with other antitumor treatment regimens in participants of advanced solid tumor trials, measured by objective response rate (ORR)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Q3W,Intravenous Drip
Q3W,Intravenous Drip
Q3W,Intravenous Drip
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGIncidence of dose-limiting toxicity (DLT)
Safety introduction phase
Time frame: 78 Weeks
Objective response rate (ORR)
Dose expansion phase
Time frame: From start of treatment to date of documented disease progression, up to approximately 42 months
Duration of response (DoR)
Dose expansion phase
Time frame: Time from initial response (CR or PR) to date of documented disease progression or death (due to any cause) whichever occurs first, up to approximately 42 months
Disease control rate (DCR)
Dose expansion phase
Time frame: From start of treatment to date of documented disease progression, up to approximately 42 months
Progression Free Survival (PFS)
Dose expansion phase
Time frame: up to 42 months
Overall Survival (OS)
Dose expansion phase
Time frame: up to 42 months
AE and SAE
Safety introduction phase/Dose expansion phase
Time frame: From signing the ICF until 28 days after EOT or accept other anti-cancer therapy,up to 40 days after last study dose
Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve from time zero to the last quantifiable concentration (AUC last)
safety introduction phase/Dose expansion phase
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter:Area Under the Concentration-time Curve over a dosing interval (τ) at steady state(AUC tau)
safety introduction phase/Dose expansion phase
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter:Maximum Observed Concentration(Cmax)
safety introduction phase/Dose expansion phase
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter:Time to Reach Maximum Concentration(Tmax)
safety introduction phase/Dose expansion phase
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter:Elimination Half-life(T 1/2)
safety introduction phase/Dose expansion phase
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter:Maximum Steady-State Concentration(Cmax, ss)
safety introduction phase/Dose expansion phase
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter:Minimum Steady-State Concentration(Cmin, ss)
safety introduction phase/Dose expansion phase
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter:Clearance at Steady State(CLss)
safety introduction phase/Dose expansion phase
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter:Volume of Distribution at Steady State(Vss)
safety introduction phase/Dose expansion phase
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter:Accumulation Ratio based on AUC(Rac, AUC)
safety introduction phase/Dose expansion phase
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter:Accumulation Ratio based on Cmax(Rac, Cmax)
safety introduction phase/Dose expansion phase
Time frame: up to 42 months
Pharmacokinetic (PK) Parameter:Fluctuation Index / Degree of Fluctuation
safety introduction phase/Dose expansion phase
Time frame: up to 42 months
immunogenicity Parameter:Anti-Drug Antibody(ADA)
safety introduction phase/Dose expansion phase
Time frame: up to 42 months
immunogenicity Parameter:Neutralizing Antibody(Nab)
safety introduction phase/Dose expansion phase
Time frame: up to 42 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.