For Phase I Dose Escalation Stage, to assess the safety and tolerability of LM-299 in patients with advanced solid tumors,determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and explorethe recommended dose for expansion (RDE) in patients with advanced solid tumours.. For Phase II Dose Expansion Stage, to assess the antitumor activity of LM-299 in patients with various advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Q2W/Q3W,Intravenous Drip
One Clinical Research
Perth, Western Australia, Australia
NOT_YET_RECRUITINGthe first affiliated hospital of Xinxiang medical University
Xinxiang, Henan, China
NOT_YET_RECRUITINGLiaocheng people's hospital
Liaocheng, Shandong, China
Incidence of dose-limitingtoxicity (DLT)
Phase 1
Time frame: 53 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Phase 1
Time frame: 53 weeks
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Phase 1
Time frame: 53 weeks
Overall Response Rate (ORR)
Phase 2
Time frame: 50 weeks
PK Parameter: Area Under the Concentration-time Curve(AUClast)
Phase 1 and 2
Time frame: 103 weeks
PK Parameter: Area Under the Concentration-time Curve(AUCtau)
Phase 1 and 2
Time frame: 103 weeks
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Phase 1 and 2
Time frame: 103 weeks
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Phase 1 and 2
Time frame: 103 weeks
PK Parameter: Elimination Half-life (t1/2)
Phase 1 and 2
Time frame: 103 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Zibo municipal hospital
Zibo, Shandong, China
NOT_YET_RECRUITINGShanghai Dongfang Hospital (Tongji University Affiliated Dongfang Hospital)
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGShanghai GoBroad Cancer Hospital China Pharmaceutical University
Shanghai, Shanghai Municipality, China
RECRUITINGPK Parameter: Steady State Maximum Concentration(Cmax,ss)
Phase 1 and 2
Time frame: 103 weeks
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Phase 1 and 2
Time frame: 103 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
Phase 1 and 2
Time frame: 103 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
Phase 1 and 2
Time frame: 103 weeks
PK Parameter: Accumulation Ratio (Rac AUC)
Phase 1 and 2
Time frame: 103 weeks
PK Parameter: Degree of Fluctuation (DF)
Phase 1 and 2
Time frame: 103 weeks
Overall Response Rate (ORR)
Phase 1
Time frame: 53 weeks
Duration of Response (DOR) in Month
Phase 1 and 2
Time frame: 103 weeks
Disease control rate (DCR) in percentage
Phase 1 and 2
Time frame: 103 weeks
progression-free survival (PFS) in Month
Phase 1 and 2
Time frame: 103 weeks
Overall survival (OS) in Month
Phase 1 and 2
Time frame: 103 weeks
PK Parameter: Accumulation Ratio (Rac Cmax)
Phase 1 and 2
Time frame: 103 weeks