This study is to assess the safety and tolerability, obtain Maximum Tolerated Dose (MTD) and/or the recommended phase 2 dose (RP2D) of LM-101 as a single agent or in combination in patients with advanced malignant tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
139
Administered intravenously
Administered intravenously
Administered intravenously
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGZhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGLinyi Cancer Hospital
Linyi, Shandong, China
NOT_YET_RECRUITINGIncidence of adverse events (AEs)
Phase 1
Time frame: 48 weeks
Incidence of dose-limitingtoxicity (DLT)
Phase 1
Time frame: 48 weeks
Incidence of serious adverse event (SAE)
Phase 1
Time frame: 48 weeks
Temperature in ℃
Phase 1
Time frame: 48 weeks
Pulse in BPM(Beat per Minute)
Phase 1
Time frame: 48 weeks
Blood Pressure in mmHg
Phase 1
Time frame: 48 weeks
Weight in Kg
Phase 1
Time frame: 48 weeks
Height in centimeter
Phase 1
Time frame: 48 weeks
Laboratory tests-Blood Routine examination
Phase 1
Time frame: 48 weeks
Laboratory tests-Urine Routine test
Phase 1
Time frame: 48 weeks
Laboratory tests-Blood biochemistry
Phase 1
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Beijing Tongren Hospital, CMU
Beijing, China
TERMINATEDFudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGTime frame: 48 weeks
Laboratory tests- Coangulation function
Phase 1
Time frame: 48 weeks
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Phase 1
Time frame: 48 weeks
12-lead electrocardiogram (ECG) in QTcF.
Phase 1
Time frame: 48 weeks
12-lead electrocardiogram (ECG) in QT.
Phase 1
Time frame: 48 weeks
12-lead electrocardiogram (ECG) in QRS.
Phase 1
Time frame: 48 weeks
12-lead electrocardiogram (ECG) in HR.
Phase 1
Time frame: 48 weeks
12-lead electrocardiogram (ECG) in RR.
Phase 1
Time frame: 48 weeks
12-lead electrocardiogram (ECG) in PR.
Phase 1
Time frame: 48 weeks
ECOG(Eastern Cooperative Oncology Group) score
Phase 1
Time frame: 48 weeks
Overall Response Rate (ORR)
Phase 2
Time frame: 64 weeks
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Phase 1 and 2
Time frame: 112 weeks
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Phase 1 and 2
Time frame: 112 weeks
PK Parameter: Area Under the Concentration-time Curve(AUC)
Phase 1 and 2
Time frame: 112 weeks
PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Phase 1 and 2
Time frame: 112 weeks
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Phase 1 and 2
Time frame: 112 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Phase 1 and 2
Time frame: 112 weeks
PK Parameter: Accumulation Ratio (Rac)
Phase 1 and 2
Time frame: 48 weeks
PK Parameter: Elimination Half-life (t1/2)
Phase 1
Time frame: 112 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Phase 1 and 2
Time frame: 112 weeks
PK Parameter: Degree of Fluctuation (DF)
Phase 1 and 2
Time frame: 112 weeks
Immunogenicity of LM-101
Phase 1 and 2; Anti-Drug antibody and Nab (if neccessary) will be tested.
Time frame: 112 weeks
Receptor Occupancy of LM-101
Phase 1
Time frame: 48 weeks
Biomarker correlation (CD8/CD47/CD68/CD163/PD-L1)
Phase 1 and 2
Time frame: 112 weeks
Duration of Response (DOR) in Month
Phase 2
Time frame: 64 weeks
Disease control rate (DCR) in percentage
Phase 2
Time frame: 64 weeks
progression-free survival (PFS) in Month
Phase 2
Time frame: 64 weeks
Overall survival (OS) in Month
Phase 2
Time frame: 64 weeks
Changes of target lesions from baseline in Millimeter.
Phase 2
Time frame: 64 weeks
Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)
Phase 2
Time frame: 64 weeks
Temperature in ℃
Phase 2
Time frame: 64 weeks
Pulse in BPM(Beat per Minute)
Phase 2
Time frame: 64 weeks
Blood Pressure in mmHg
Phase 2
Time frame: 64 weeks
Weight in Kg
Phase 2
Time frame: 64 weeks
Height in centimeter
Phase 2
Time frame: 64 weeks
Laboratory tests-Blood Routine examination
Phase 2
Time frame: 64 weeks
Laboratory tests-Urine Routine test
Phase 2
Time frame: 64 weeks
Laboratory tests-Blood biochemistry
Phase 2
Time frame: 64 weeks
Laboratory tests- Coangulation function
Phase 2
Time frame: 64 weeks
12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc.
Phase 2
Time frame: 64 weeks
ECOG(Eastern Cooperative Oncology Group) score
Phase 2
Time frame: 64 weeks