This is a first-in-human, Phase I/II, open-label, multi-centre, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumour activity of LM-108 as a single agent or in combination with an anti-PD-1 mAb in subjects with solid tumours.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Administered intravenously
Administered intravenously
Blacktown Hospital
Sydney, New South Wales, Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia
ICON Cancer Centre
South Brisbane, Queensland, Australia
Cabrini Health Limited
Malvern, Victoria, Australia
Incidence of adverse events (AEs)
Time frame: 126 weeks
Incidence of dose-limiting toxicity (DLT)
Time frame: 126 weeks
Incidence of serious adverse event (SAE)
Time frame: 126 weeks
Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
Time frame: 126 weeks
Incidence of anti-drug antibodies to LM-108
Time frame: 126 weeks
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108
Time frame: 126 weeks
PK Parameter: Minimum Observed Concentration (Cmin) for LM-108
Time frame: 126 weeks
PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108
Time frame: 126 weeks
PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108
Time frame: 126 weeks
PK Parameter: Steady State Maximum Concentration (Cmax,ss)
Time frame: 126 weeks
PK Parameter: Steady State Minimum Concentration (Cmin, ss)
Time frame: 126 weeks
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Alfred Hospital
Melbourne, Victoria, Australia
One Clinical Research Pty Ltd.
Nedlands, Western Australia, Australia
PK Parameter: Systemic Clearance at Steady State (CLss)
Time frame: 126 weeks
PK Parameter: Accumulation Ratio (Rac)
Time frame: 126 weeks
PK Parameter: Elimination Half-life (t 1/2)
Time frame: 126 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Time frame: 126 weeks
PK Parameter: Degree of Fluctuation (DF)
Time frame: 126 weeks