Based on overall response rate (ORR) as assessed by the Independent Review Committee (IRC) against the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria for Solid Tumor Efficacy, To evaluate the efficacy of LM-108 in combination with Toripalimab in patients with advanced malignant solid tumours with unresectable or metastatic MSI-H/dMMR who have failed previous anti-PD-1 /PD-L1 therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Q3W, Intravenous Drip
Q3W, Intravenous Drip
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
ORR
Overall Response Rate assessed by Independent Review Committee against the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: 104 weeks
AEs
Incidence of adverse events
Time frame: 104 weeks
SAEs
Incidence of serious adverse events
Time frame: 104 weeks
AE/SAE
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 104 weeks
DOR
Duration of response assessed by Independent Review Committee against the RECIST v1.1
Time frame: 104 weeks
DCR
Disease control rate (DCR = CR + PR + SD) assessed by Independent Review Committee against the RECIST v1.1
Time frame: 104 weeks
PFS
Progression-free survival assessed by Independent Review Committee against the RECIST v1.1
Time frame: 104 weeks
Progression-free survival Rates
Independent Review Committee evaluated the Progression-free survival rates at 3 and 6 months based on RECIST v1.1
Time frame: 104 weeks
ORR
Overall Response Rate assessed by investigator against the RECIST v1.1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 104 weeks
DOR
Duration of response assessed by investigator against the RECIST v1.1
Time frame: 104 weeks
DCR
Disease control rate (DCR = CR + PR + SD) assessed by investigator against the RECIST v1.1
Time frame: 104 weeks
PFS
Progression-free survival assessed by investigator against the RECIST v1.1
Time frame: 104 weeks
Progression-free survival Rates
Investigator evaluated the Progression-free survival rates at 3 and 6 months based on RECIST v1.1
Time frame: 104 weeks
OS
Overall survival
Time frame: 104 weeks
OS rates
Overall survival rates
Time frame: 104 weeks
Temperatures
Temperatures
Time frame: 104 weeks
Pulse in BPM
Beat per Minute
Time frame: 104 weeks
Blood Pressure
Blood Pressure in mmHg,Both systolic pressure and diastolic pressure
Time frame: 104 weeks
Weight
Weight in Kg
Time frame: 104 weeks
Height
Height in centimeter
Time frame: 104 weeks
Complete Blood Count
Time frame: 104 weeks
Urine Routine test
Laboratory tests-Urine Routine test
Time frame: 104 weeks
Blood biochemistry
Laboratory tests-Blood biochemistry
Time frame: 104 weeks
Coagulation function
Laboratory tests-Coagulation function
Time frame: 104 weeks
Thyroid function
Laboratory tests-Thyroid function
Time frame: 104 weeks
Stool routine examination
Laboratory tests-Stool routine examination
Time frame: 104 weeks
Virological examination
Laboratory tests-Virological examination
Time frame: 104 weeks
Pregnancy check
Laboratory tests-Pregnancy check
Time frame: 104 weeks
LVEF
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Time frame: 104 weeks
HR
Electrocardiogram (ECG) in HR
Time frame: 104 weeks
RR
Electrocardiogram (ECG) in RR
Time frame: 104 weeks
PR
Electrocardiogram (ECG) in PR
Time frame: 104 weeks
QRS
Electrocardiogram (ECG) in QRS
Time frame: 104 weeks
QT
Electrocardiogram (ECG) in QT
Time frame: 104 weeks
QTcF
Electrocardiogram (ECG) in QTcF
Time frame: 104 weeks
ECOG score
Eastern Cooperative Oncology Group score
Time frame: 104 weeks