This study is to evaluate the efficacy and safety of the LM-24C5 in combination with other therapies in subjects with CEACAM5-positive advanced solid tumor
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Q2W Administered intravenously Drug: Penpulimab Q2W Administered intravenously Drug: Docetaxel Q3W Administered intravenously
Q2W Administered intravenously Drug: Penpulimab Q2W Administered intravenously Drug:Trifluridine and Tipiracil Hydrochloride Tablets BID,Oral Administration Drug:Bevacizumab Injection Q2W Administered intravenously
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGShanghai East Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGORR
Objective response rate
Time frame: 110weeks
Anti-tumor Activity
Based on RECIST v1.1, evaluated progression-free survival (PFS), duration of response (DOR), disease control rate (DCR = CR + PR + SD), and change in target lesions relative to baseline; overall survival (OS).
Time frame: 110weeks
PK Parameter(AUClast)
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Time frame: baseline and 110 weeks
Immunogenicity of LM-24C5
ADA、Nab
Time frame: baseline and 110 weeks
Correlation between CEACAM5 and/or PD-L1 expression levels and treatment efficacy.
Correlation between CEACAM5 and/or PD-L1 expression levels and treatment efficacy.
Time frame: baseline and 110 weeks
PK Parameter(AUCtau)
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Time frame: baseline and 110 weeks
PK Parameter(Cmax)
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Time frame: baseline and 110 weeks
PK Parameter(Tmax)
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: baseline and 110 weeks
PK Parameter(T1/2)
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Time frame: baseline and 110 weeks
PK Parameter(ss)
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Time frame: baseline and 110 weeks
PK Parameter(Cmin)
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Time frame: baseline and 110 weeks
PK Parameter(CLss)
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Time frame: baseline and 110 weeks
PK Parameter(Vss)
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Time frame: baseline and 110 weeks
PK Parameter(Rac)
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Time frame: baseline and 110 weeks
PK Parameter(AUC)
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Time frame: baseline and 110 weeks
PK Parameter(Cmax)
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Rac, Cmax, DF, etc.
Time frame: baseline and 110 weeks
PK Parameter(DF)
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Rac, Cmax, DF, etc.
Time frame: baseline and 110 weeks