A Phase I/II, First-in-Human (FIH), Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-24C5 in Patients With Advanced Solid Tumors
Summary
To assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-24C5 in subjects with advanced solid tumors.
Arms & interventions
- DrugLM-24C5
Administered intravenously
Outcome measures
Primary
Incidence of adverse events (AEs)
Phase 1
Time frame: 60 weeks
Incidence of dose-limiting toxicity (DLT)
Phase 1
Time frame: 60 weeks
Incidence of serious adverse event (SAE)
Phase 1
Time frame: 60 weeks
Ear Temperature
Phase 1
Time frame: 60 weeks
Pulse in BPM(Beat per Minute)
Phase 1
Time frame: 60 weeks
Blood Pressure in mmHg (Both Systolic and Diastolic blood pressure)
Phase 1
Time frame: 60 weeks
Number of participants with abnormal Hematology test results
Phase 1
Time frame: 60 weeks
Number of participants with abnormal Urinalysis test results
Phase 1
Time frame: 60 weeks
Number of participants with abnormal Blood Biochemistry test results
Phase 1
Time frame: 60 weeks
Number of participants with abnormal Coagulation test results in PT(Prothrombin time), APTT(Activated partial thromboplastin time), FIB(Fibrinogen), TT(Thrombin time) and INR(International normalized ratio).
Phase 1
Time frame: 60 weeks
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Phase 1
Time frame: 60 weeks
12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc.
Phase 1
Time frame: 60 weeks
ECOG(Eastern Cooperative Oncology Group) score
Phase 1
Time frame: 60 weeks
Overall Response Rate (ORR)
Phase 2
Time frame: 36 weeks
Secondary
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Time frame: 96 weeks
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Time frame: 96 weeks
PK Parameter: Area Under the Concentration-time Curve(AUC)
Time frame: 96 weeks
PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Time frame: 96 weeks
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Time frame: 96 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Time frame: 96 weeks
PK Parameter: Accumulation Ratio (Rac)
Time frame: 96 weeks
PK Parameter: Elimination Half-life (t1/2)
Time frame: 96 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Time frame: 96 weeks
PK Parameter: Degree of Fluctuation (DF)
Time frame: 96 weeks
Immunogenicity of LM-24C5
Time frame: 96 weeks
Duration of Response (DOR) in Month
Time frame: 96 weeks
Disease control rate (DCR) in percentage
Time frame: 96 weeks
progression-free survival (PFS) in Month
Time frame: 96 weeks
Overall survival (OS) in Month
Time frame: 60 weeks
Changes of target lesions from baseline in Millimeter.
Time frame: 96 weeks
Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)
Time frame: 36 weeks
Ear Temperature
Time frame: 36 weeks
Pulse in BPM (Beat per Minute)
Time frame: 36 weeks
Blood Pressure in mmHg (Both Systolic and Diastolic blood pressure)
Time frame: 36 weeks
Number of participants with abnormal Hematology test results
Time frame: 36 weeks
Number of participants with abnormal Urinalysis test results
Time frame: 36 weeks
Number of participants with abnormal Blood Biochemistry test results
Time frame: 36 weeks
Number of participants with abnormal Coagulation test results in PT(Prothrombin time), APTT(Activated partial thromboplastin time), FIB(Fibrinogen), TT(Thrombin time) and INR(International normalized ratio).
Time frame: 36 weeks
12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc.
Time frame: 36 weeks
ECOG(Eastern Cooperative Oncology Group) score
Time frame: 36 weeks
Eligibility criteria
Study locations (6)
University of Southern California (USC) - Norris Comprehensive Cancer Center
Los Angeles, California, 90089
Ocala Oncology
Ocala, Florida, 34474
Indiana University Melvan and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
The Christ Hospital
Cincinnati, Ohio, 45219
Mary Crowley Cancer Research Center
Dallas, Texas, 75230
Virginia Cancer Specialists, P.C.
Fairfax, Virginia, 22031