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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-24C5 in combination with anti-tumor therapies | Experimental |
| |
| LM-24C5 in combination with other anti-tumor therapies | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-24C5 | Drug | Q2W Administered intravenously Drug: Penpulimab Q2W Administered intravenously Drug: Docetaxel Q3W Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate | 110weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 110weeks |
| PK Parameter(AUClast) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengmeng Liu | Contact | +8613918118040 | mengmengliu@lanovamed.com | |
| Paul Kong | Contact | +8613564682439 | paulkong@lanovamed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
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| LM-24C5 | Drug | Q2W Administered intravenously Drug: Penpulimab Q2W Administered intravenously Drug:Trifluridine and Tipiracil Hydrochloride Tablets BID,Oral Administration Drug:Bevacizumab Injection Q2W Administered intravenously |
|
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc. |
| baseline and 110 weeks |
| Immunogenicity of LM-24C5 | ADA、Nab | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | baseline and 110 weeks |
| Shanghai East Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200123 | China |
|