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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07112222
Registration number
NCT07112222
Ethics application status
Date submitted
16/07/2025
Date registered
8/08/2025
Date last updated
9/09/2025
Titles & IDs
Public title
A Study of LM-350 in Subjects With Advanced Solid Tumours
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Scientific title
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-350 in Patients With Advanced Solid Tumors
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Secondary ID [1]
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LM350-01-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malignant Tumors
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LM-350 for injection
Experimental: Phase I Dose Escalation Part and Dose Confirmation Part -
Treatment: Drugs: LM-350 for injection
Q3W,Intravenous Drip
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of dose-limitingtoxicity (DLT)
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Assessment method [1]
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Phase I
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Timepoint [1]
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78 weeks
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Primary outcome [2]
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Incidence of Treatment-Emergent Adverse Events (AEs)
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Assessment method [2]
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Phase I
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Timepoint [2]
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78 weeks
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Primary outcome [3]
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Incidence of serious adverse events (SAEs)
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Assessment method [3]
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Phase I
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Timepoint [3]
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78 weeks
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Primary outcome [4]
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Temperature (Celsius)
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Assessment method [4]
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Phase I
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Timepoint [4]
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78 weeks
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Primary outcome [5]
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Pulse in BPM(Beat per Minute)
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Assessment method [5]
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Phase I
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Timepoint [5]
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78 weeks
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Primary outcome [6]
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Blood Pressure in mmHg
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Assessment method [6]
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Phase I
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Timepoint [6]
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78 weeks
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Primary outcome [7]
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Weight in Kg
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Assessment method [7]
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Phase I
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Timepoint [7]
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78 weeks
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Primary outcome [8]
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Height in centimeter
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Assessment method [8]
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Phase I
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Timepoint [8]
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78 weeks
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Primary outcome [9]
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Blood Routine examination -> Complete Blood Count
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Assessment method [9]
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Phase I
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Timepoint [9]
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78 weeks
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Primary outcome [10]
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Urine Routine examination ->Urinalysis
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Assessment method [10]
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Phase I
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Timepoint [10]
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78 weeks
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Primary outcome [11]
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Blood Biochemistry test -> Electrolytes and Metabolic Parameters
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Assessment method [11]
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Phase I
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Timepoint [11]
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78 weeks
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Primary outcome [12]
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Coagulation function test-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT), International normalized
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Assessment method [12]
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Phase I
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Timepoint [12]
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78 weeks
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Primary outcome [13]
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Thyroid function test-For the detection of Thyroid-stimulating hormone (TSH), free T3, free T4
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Assessment method [13]
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Phase I
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Timepoint [13]
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78 weeks
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Primary outcome [14]
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Pregnancy test
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Assessment method [14]
0
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Phase I
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Timepoint [14]
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78 weeks
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Primary outcome [15]
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Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
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Assessment method [15]
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Phase I
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Timepoint [15]
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78 weeks
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Primary outcome [16]
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12-lead electrocardiogram (ECG) in HR
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Assessment method [16]
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0
Phase I
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Timepoint [16]
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78 weeks
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Primary outcome [17]
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12-lead electrocardiogram (ECG) in RR
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Assessment method [17]
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0
Phase I
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Timepoint [17]
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78 weeks
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Primary outcome [18]
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12-lead electrocardiogram (ECG) in QRS
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Assessment method [18]
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0
Phase I
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Timepoint [18]
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78 weeks
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Primary outcome [19]
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12-lead electrocardiogram (ECG) in QT
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Assessment method [19]
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0
Phase I
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Timepoint [19]
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78 weeks
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Primary outcome [20]
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12-lead electrocardiogram (ECG) in QTcF
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Assessment method [20]
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Phase I
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Timepoint [20]
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78 weeks
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Primary outcome [21]
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ECOG(Eastern Cooperative Oncology Group) score
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Assessment method [21]
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Phase I
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Timepoint [21]
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78 weeks
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Primary outcome [22]
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Objective Response Rate (ORR)
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Assessment method [22]
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Phase II
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Timepoint [22]
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130 weeks
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Secondary outcome [1]
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Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
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Assessment method [1]
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Phase I/II
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Timepoint [1]
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130 weeks
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Secondary outcome [2]
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PK Parameter:Time of Maximum Observed Concentration (Tmax)
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Assessment method [2]
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Phase I/II
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Timepoint [2]
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130 weeks
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Secondary outcome [3]
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PK Parameter: Area Under the Concentration-time Curve(AUC)
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Assessment method [3]
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Phase I/II
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Timepoint [3]
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130 weeks
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Secondary outcome [4]
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PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)
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Assessment method [4]
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0
Phase I/II
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Timepoint [4]
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130 weeks
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Secondary outcome [5]
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PK Parameter: Steady State Minimum Concentration(Cmin,ss)
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Assessment method [5]
0
0
Phase I/II
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Timepoint [5]
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130 weeks
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Secondary outcome [6]
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PK Parameter: Systemic Clearance at Steady State (CLss)
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Assessment method [6]
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0
Phase I/II
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Timepoint [6]
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130 weeks
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Secondary outcome [7]
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PK Parameter: Accumulation Ratio (Rac)
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Assessment method [7]
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Phase I/II
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Timepoint [7]
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130 weeks
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Secondary outcome [8]
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PK Parameter: Elimination Half-life (t1/2)
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Assessment method [8]
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Phase I/II
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Timepoint [8]
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130 weeks
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Secondary outcome [9]
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PK Parameter: Volume of Distribution at Steady-State (Vss)
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Assessment method [9]
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Phase I/II
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Timepoint [9]
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130 weeks
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Secondary outcome [10]
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PK Parameter: Degree of Fluctuation (DF)
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Assessment method [10]
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Phase I/II
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Timepoint [10]
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130 weeks
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Secondary outcome [11]
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Immunogenicity testing->Anti-Drug Antibody test
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Assessment method [11]
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Phase I/II
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Timepoint [11]
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130 weeks
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Secondary outcome [12]
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Objective Response Rate (ORR)
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Assessment method [12]
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Phase I
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Timepoint [12]
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130 weeks
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Secondary outcome [13]
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Duration of Response (DOR) in Month
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Assessment method [13]
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Phase I/II
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Timepoint [13]
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130 weeks
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Secondary outcome [14]
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Disease control rate (DCR) in percentage
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Assessment method [14]
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Phase I/II
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Timepoint [14]
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130 weeks
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Secondary outcome [15]
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Progression-free survival (PFS) in Month
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Assessment method [15]
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Phase I/II
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Timepoint [15]
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130 weeks
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Secondary outcome [16]
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Changes of target lesions from baseline in Millimeter
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Assessment method [16]
0
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Phase I/II
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Timepoint [16]
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130 weeks
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Secondary outcome [17]
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Incidence of adverse events (AEs)
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Assessment method [17]
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Phase II
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Timepoint [17]
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130 weeks
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Secondary outcome [18]
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Incidence of serious adverse events (SAEs)
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Assessment method [18]
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Phase II
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Timepoint [18]
0
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130 weeks
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Secondary outcome [19]
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Temperature (Celsius)
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Assessment method [19]
0
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Phase II
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Timepoint [19]
0
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130 weeks
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Secondary outcome [20]
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Pulse in BPM(Beat per Minute)
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Assessment method [20]
0
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Phase II
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Timepoint [20]
0
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130 weeks
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Secondary outcome [21]
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Blood Pressure in mmHg
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Assessment method [21]
0
0
Phase II
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Timepoint [21]
0
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130 weeks
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Secondary outcome [22]
0
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Weight in Kg
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Assessment method [22]
0
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Phase II
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Timepoint [22]
0
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130 weeks
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Secondary outcome [23]
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Height in centimeter
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Assessment method [23]
0
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Phase II
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Timepoint [23]
0
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130 weeks
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Secondary outcome [24]
0
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Blood Routine examination -> Complete Blood Count
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Assessment method [24]
0
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Phase II
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Timepoint [24]
0
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130 weeks
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Secondary outcome [25]
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Urine Routine examination ->Urinalysis
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Assessment method [25]
0
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Phase II
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Timepoint [25]
0
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130 weeks
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Secondary outcome [26]
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Blood Biochemistry test -> Electrolytes and Metabolic Parameters
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Assessment method [26]
0
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Phase II
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Timepoint [26]
0
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130 weeks
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Secondary outcome [27]
0
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Coagulation function test-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT), International normalized ratio (INR)
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Assessment method [27]
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Phase II
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Timepoint [27]
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130 weeks
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Secondary outcome [28]
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Thyroid function test-For the detection of Thyroid-stimulating hormone (TSH), free T3, free T4
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Assessment method [28]
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Phase II
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Timepoint [28]
0
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130 weeks
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Secondary outcome [29]
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Pregnancy test
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Assessment method [29]
0
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Phase II
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Timepoint [29]
0
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130 weeks
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Secondary outcome [30]
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Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
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Assessment method [30]
0
0
Phase II
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Timepoint [30]
0
0
130 weeks
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Secondary outcome [31]
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ECOG(Eastern Cooperative Oncology Group) score
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Assessment method [31]
0
0
Phase II
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Timepoint [31]
0
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130 weeks
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Secondary outcome [32]
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12-lead electrocardiogram (ECG) in HR
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Assessment method [32]
0
0
Phase II
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Timepoint [32]
0
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130 weeks
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Secondary outcome [33]
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12-lead electrocardiogram (ECG) in RR
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Assessment method [33]
0
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Phase II
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Timepoint [33]
0
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130 weeks
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Secondary outcome [34]
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12-lead electrocardiogram (ECG) in PR
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Assessment method [34]
0
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Phase II
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Timepoint [34]
0
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130 weeks
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Secondary outcome [35]
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12-lead electrocardiogram (ECG) in QRS
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Assessment method [35]
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0
Phase II
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Timepoint [35]
0
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130 weeks
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Secondary outcome [36]
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12-lead electrocardiogram (ECG) in QT
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Assessment method [36]
0
0
Phase II
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Timepoint [36]
0
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130 weeks
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Secondary outcome [37]
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12-lead electrocardiogram (ECG) in QTcF
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Assessment method [37]
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Phase II
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Timepoint [37]
0
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130 weeks
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Secondary outcome [38]
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Biomarker test -> Tumor tissue biomarker test
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Assessment method [38]
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Phase I/II
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Timepoint [38]
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130 weeks
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Eligibility
Key inclusion criteria
1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
2. Participant must be =18 years or the legal age of consent at the time of signing the ICF.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Life expectancy = 3 months.
5. Patients with advanced solid tumors confirmed by histopathological diagnosis who have failed standard treatment, are intolerant to standard treatment, or for whom standard treatment is currently unsuitable.
6. Pre-treatment archived tumour tissue (within 3 years) or on-treatment tumour biopsy could be provided for biomarker analysis.
7. Must have at least one measurable lesion according to RECIST v1.1.
8. Adequate organ and bone marrow function as defined by protocol.
9. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Participate in any other clinical trial within 28 days prior to 1st dosing of LM-350.
2. Subjects who have received treatment with the same targeting.
3. Subjects who have received the following anti-tumor treatments within the specified time periods prior to the first dosing of LM-350.
4. Any adverse event from prior anti-tumour therapy has not yet recovered to = grade 1 of CTCAE v5.0.
5. Subjects with uncontrolled tumour-related pain.
6. Subjects with known central nervous system (CNS) or meningeal metastasis.
7. Subjects who have clinically uncontrollable third-space fluid accumulation.
8. Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody.
9. Subjects who take systemic corticosteroids (= 10 mg/day of prednisone or equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dose of LM-350.
10. Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
11. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, and any autoimmune, or prior pneumonectomy.
12. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-350.
13. Current unstable of full-dose oral or parenteral anticoagulants or thrombolytic agents for > 2 weeks prior to the first dose of LM-350.
14. Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-350.
15. Subjects who have severe cardiovascular disease.
16. Subjects who have uncontrolled or severe illness.
17. Subjects who have a history of immunodeficiency disease.
18. HIV infection, active infection including tuberculosis, HBV and HCV infection.
19. Subjects who have other active malignancies which are likely to require the treatment.
20. Spinal cord compression, symptomatic and unstable brain metastases.
21. Child-bearing potential female who have positive results in pregnancy test or are lactating.
22. Subjects who have psychiatric illness or disorders that may preclude study compliance.
23. Subject who is judged as not eligible to participate in this study by the investigator.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
30/09/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2030
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Actual
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Sample size
Target
55
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peninsula and South Eastern Haematology and Oncology Group - Frankston
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Recruitment postcode(s) [1]
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- Frankston
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
LaNova Medicines Limited
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT07112222
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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0
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Phone
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Fax
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0
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Email
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Contact person for public queries
Name
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0
Alex Yuan
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Address
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0
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Country
0
0
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Phone
0
0
+8615901815211
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07112222
Download to PDF