This study is to evaluate the efficacy of the LM-302 Combination With Other Therapies in patients with CLDN18.2-positive Advanced Digestive Tract Tumor.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
276
Q2W/Q3W,Administered intravenously
Q2W/Q3W,Administered intravenously
BID,Oral Administration
Shanghai East Hospital
Shanghai, China
RECRUITINGPFS
Progression free survival according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: 112 weeks
ORR
Objective response rate (ORR)
Time frame: 112 weeks
DOR
Duration of response (DOR)
Time frame: 112 weeks
DCR
Disease control rate (DCR = CR + PR + SD)
Time frame: 112 weeks
OS
Overall survival (OS)
Time frame: 112 weeks
AEs
Incidence of adverse events
Time frame: 112 weeks
SAEs
Incidence of serious adverse events
Time frame: 112 weeks
Temperatures
Temperatures
Time frame: 112 weeks
Pulse in BPM
Beat per Minute
Time frame: 112 weeks
Blood Pressure
Blood Pressure in mmHg
Time frame: 112 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
BID,Oral Administration
Q4W,Administered intravenously
QD,Oral Administration
Q4W,Administered intravenously
Weight
Weight in Kg
Time frame: 112 weeks
Height
Height in centimeter
Time frame: 112 weeks
Blood Routine examination
Laboratory tests-Blood Routine examination
Time frame: 112 weeks
Urine Routine test
Laboratory tests-Urine Routine test
Time frame: 112 weeks
Blood biochemistry
Laboratory tests-Blood biochemistry
Time frame: 112 weeks
Coagulation function
Laboratory tests- Coagulation function
Time frame: 112 weeks
LVEF
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Time frame: 112 weeks
HR
12-lead electrocardiogram (ECG) in HR
Time frame: 112 weeks
RR
12-lead electrocardiogram (ECG) in RR
Time frame: 112 weeks
PR
12-lead electrocardiogram (ECG) in PR
Time frame: 112 weeks
QRS
12-lead electrocardiogram (ECG) in QRS
Time frame: 112 weeks
QT
12-lead electrocardiogram (ECG) in QT
Time frame: 112 weeks
QTcF
12-lead electrocardiogram (ECG) in QTcF
Time frame: 112 weeks
ECOG score
Eastern Cooperative Oncology Group score
Time frame: 112 weeks
PK Parameter:Cmax
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Time frame: 112 weeks
PK Parameter:Tmax
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Time frame: 112 weeks
PK Parameter: AUC
PK Parameter: Area Under the Concentration-time Curve(AUC)
Time frame: 112 weeks
PK Parameter: Cmax,ss
PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Time frame: 112 weeks
PK Parameter: Cmin,ss
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Time frame: 112 weeks
PK Parameter: CLss
PK Parameter: Systemic Clearance at Steady State (CLss)
Time frame: 112 weeks
PK Parameter:Rac
PK Parameter: Accumulation Ratio (Rac)
Time frame: 112 weeks
PK Parameter: t1/2
PK Parameter: Elimination Half-life (t1/2)
Time frame: 112 weeks
PK Parameter: Vss
PK Parameter: Volume of Distribution at Steady-State (Vss)
Time frame: 112 weeks
PK Parameter: DF
PK Parameter: Degree of Fluctuation (DF)
Time frame: 112 weeks
Immunogenicity of LM-302
Anti-Drug antibody and Nab (if neccessary) will be tested.
Time frame: 112 weeks
Biomarker correlation
For the detection of CLDN18.2 and PD-L1
Time frame: 112 weeks
AE/SAE
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 112 weeks