For Phase I Dose Escalation Stage, to assess the safety and tolerability of LM-350 in patients with advanced solid tumors,determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and explore the relationship between the biomarkers and the anti-tumor activity of LM-350. For Phase II Dose Expansion Stage, to assess the preliminary anti-tumor activity of LM-350 in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Q3W,Intravenous Drip
Cancer Care Wollongong Pty Limited
Wollongong, New South Wales, Australia
RECRUITINGCancer Research SA
Adelaide, South Australia, Australia
RECRUITINGPeninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
RECRUITINGIncidence of dose-limitingtoxicity (DLT)
Phase I
Time frame: 78 weeks
Incidence of Treatment-Emergent Adverse Events (AEs)
Phase I
Time frame: 78 weeks
Incidence of serious adverse events (SAEs)
Phase I
Time frame: 78 weeks
Temperature (Celsius)
Phase I
Time frame: 78 weeks
Pulse in BPM(Beat per Minute)
Phase I
Time frame: 78 weeks
Blood Pressure in mmHg
Phase I
Time frame: 78 weeks
Weight in Kg
Phase I
Time frame: 78 weeks
Height in centimeter
Phase I
Time frame: 78 weeks
Blood Routine examination -> Complete Blood Count
Phase I
Time frame: 78 weeks
Urine Routine examination ->Urinalysis
Phase I
Time frame: 78 weeks
Blood Biochemistry test -> Electrolytes and Metabolic Parameters
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPhase I
Time frame: 78 weeks
Coagulation function test-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT), International normalized
Phase I
Time frame: 78 weeks
Pregnancy test
Phase I
Time frame: 78 weeks
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Phase I
Time frame: 78 weeks
12-lead electrocardiogram (ECG) in HR
Phase I
Time frame: 78 weeks
12-lead electrocardiogram (ECG) in RR
Phase I
Time frame: 78 weeks
12-lead electrocardiogram (ECG) in QRS
Phase I
Time frame: 78 weeks
12-lead electrocardiogram (ECG) in QT
Phase I
Time frame: 78 weeks
12-lead electrocardiogram (ECG) in QTcF
Phase I
Time frame: 78 weeks
ECOG(Eastern Cooperative Oncology Group) score
Phase I
Time frame: 78 weeks
Objective Response Rate (ORR)
Phase II
Time frame: 130 weeks
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Phase I/II
Time frame: 130 weeks
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Phase I/II
Time frame: 130 weeks
PK Parameter: Area Under the Concentration-time Curve(AUC)
Phase I/II
Time frame: 130 weeks
PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Phase I/II
Time frame: 130 weeks
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Phase I/II
Time frame: 130 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Phase I/II
Time frame: 130 weeks
PK Parameter: Accumulation Ratio (Rac)
Phase I/II
Time frame: 130 weeks
PK Parameter: Elimination Half-life (t1/2)
Phase I/II
Time frame: 130 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Phase I/II
Time frame: 130 weeks
PK Parameter: Degree of Fluctuation (DF)
Phase I/II
Time frame: 130 weeks
Immunogenicity testing->Anti-Drug Antibody test
Phase I/II
Time frame: 130 weeks
Objective Response Rate (ORR)
Phase I
Time frame: 130 weeks
Duration of Response (DOR) in Month
Phase I/II
Time frame: 130 weeks
Disease control rate (DCR) in percentage
Phase I/II
Time frame: 130 weeks
Progression-free survival (PFS) in Month
Phase I/II
Time frame: 130 weeks
Overall survival (OS) in Month
Phase I/II
Time frame: 130 weeks
Changes of target lesions from baseline in Millimeter
Phase I/II
Time frame: 130 weeks
Incidence of adverse events (AEs)
Phase II
Time frame: 130 weeks
Incidence of serious adverse events (SAEs)
Phase II
Time frame: 130 weeks
Temperature (Celsius)
Phase II
Time frame: 130 weeks
Pulse in BPM(Beat per Minute)
Phase II
Time frame: 130 weeks
Blood Pressure in mmHg
Phase II
Time frame: 130 weeks
Weight in Kg
Phase II
Time frame: 130 weeks
Height in centimeter
Phase II
Time frame: 130 weeks
Blood Routine examination -> Complete Blood Count
Phase II
Time frame: 130 weeks
Urine Routine examination ->Urinalysis
Phase II
Time frame: 130 weeks
Blood Biochemistry test -> Electrolytes and Metabolic Parameters
Phase II
Time frame: 130 weeks
Coagulation function test-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT), International normalized ratio (INR)
Phase II
Time frame: 130 weeks
Pregnancy test
Phase II
Time frame: 130 weeks
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Phase II
Time frame: 130 weeks
ECOG(Eastern Cooperative Oncology Group) score
Phase II
Time frame: 130 weeks
12-lead electrocardiogram (ECG) in HR
Phase II
Time frame: 130 weeks
12-lead electrocardiogram (ECG) in RR
Phase II
Time frame: 130 weeks
12-lead electrocardiogram (ECG) in PR
Phase II
Time frame: 130 weeks
12-lead electrocardiogram (ECG) in QRS
Phase II
Time frame: 130 weeks
12-lead electrocardiogram (ECG) in QT
Phase II
Time frame: 130 weeks
12-lead electrocardiogram (ECG) in QTcF
Phase II
Time frame: 130 weeks
Biomarker test -> Tumor tissue biomarker test
Phase I/II
Time frame: 130 weeks