This study is to assess the safety and tolerability, obtain the recommended phase 2 dose(RP2D)/or Maximum Tolerated Dose (MTD) for LM-2417 as a single agent or in combination with other anti-tumour agents in subjects with advanced solid tumours.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
FuDan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence of adverse events (AEs)
Phase I/II
Time frame: 60 weeks
Incidence of dose-limitingtoxicity (DLT)
Phase I/II
Time frame: 60 weeks
Incidence of serious adverse event (SAE)
Phase I/II
Time frame: 60 weeks
Temperatures
Phase I/II
Time frame: 60 weeks
Pulse in BPM(Beat per Minute)
Phase I/II
Time frame: 60 weeks
Blood Pressure in mmHg
Phase I/II
Time frame: 60 weeks
Weight in Kg
Phase I/II
Time frame: 60 weeks
Height in centimeter
Phase I/II
Time frame: 60 weeks
Laboratory tests-Blood Routine examination
Phase I/II
Time frame: 60 weeks
Laboratory tests-Urine Routine test
Phase I/II
Time frame: 60 weeks
Laboratory tests-Blood biochemistry
Phase I/II
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Q3W,Intravenous Drip
QD,Oral Administration
QD,Oral Administration
Time frame: 60 weeks
Laboratory tests- Coangulation function
Phase I/II
Time frame: 60 weeks
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Phase I/II
Time frame: 60 weeks
12-lead electrocardiogram (ECG) in HR
Phase I/II
Time frame: 60 weeks
12-lead electrocardiogram (ECG) in RR
Phase I/II
Time frame: 60 weeks
12-lead electrocardiogram (ECG) in PR
Phase I/II
Time frame: 60 weeks
12-lead electrocardiogram (ECG) in QRS
Phase I/II
Time frame: 60 weeks
12-lead electrocardiogram (ECG) in QT
Phase I/II
Time frame: 60 weeks
12-lead electrocardiogram (ECG) in QTcF
Phase I/II
Time frame: 60 weeks
ECOG(Eastern Cooperative Oncology Group) score
Phase I/II
Time frame: 60 weeks
Overall Response Rate (ORR)
Phase I/II
Time frame: 76 weeks
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Phase I/II
Time frame: 112 weeks
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Phase I/II
Time frame: 112 weeks
PK Parameter: Area Under the Concentration-time Curve(AUC)
Phase I/II
Time frame: 112 weeks
PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Phase I/II
Time frame: 112 weeks
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Phase I/II
Time frame: 112 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Phase I/II
Time frame: 112 weeks
PK Parameter: Accumulation Ratio (Rac)
Phase I/II
Time frame: 112 weeks
PK Parameter: Elimination Half-life (t1/2)
Phase I/II
Time frame: 112 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Phase I/II
Time frame: 112 weeks
PK Parameter: Degree of Fluctuation (DF)
Phase I/II
Time frame: 112 weeks
Immunogenicity of LM-2417
Phase I/II
Time frame: 112 weeks
Biomarker correlation(NaPi2b)
Phase I/II
Time frame: 112 weeks
Duration of Response (DOR) in Month
Phase I/II
Time frame: 64 weeks
Disease control rate (DCR) in percentage
Phase I/II
Time frame: 64 weeks
progression-free survival (PFS) in Month
Phase I/II
Time frame: 64 weeks
Safety: AE/SAE (Number of participants with treatment-related adverse events as Overall survival (OS) in Month
Phase I/II
Time frame: 64 weeks
Changes of target lesions from baseline in Millimeter
Phase I/II
Time frame: 64 weeks
AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0) Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)
Phase I/II
Time frame: 64 weeks