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This study is to evaluate the efficacy of the LM-302 Combination With Other Therapies in patients with CLDN18.2-positive Advanced Digestive Tract Tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-302 in combination with Toripalimab | Experimental |
| |
| LM-302 in combination with other therapies | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-302 | Drug | Q2W/Q3W,Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression free survival according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | 112 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate (ORR) | 112 weeks |
| DOR | Duration of response (DOR) | 112 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Yuan | Contact | 021-68889618 | AlexYuan@Lanovamed.com | |
| Paul Kong | Contact | 021-68889618 | paulkong@lanovamed.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin Li | Shanghai East Hospital | Principal Investigator |
| Jieer Ying | Zhejiang Cancer Hospital | Principal Investigator |
| Haiping Jiang |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D000069287 | Capecitabine |
| D005641 | Tegafur |
| C104201 | gimeracil |
| C489337 | potassium oxonate |
| D000077594 | Nivolumab |
| C553458 | apatinib |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Toripalimab | Drug | Q2W/Q3W,Administered intravenously |
|
| Capecitabine | Drug | BID,Oral Administration |
|
| Tegafur, Gimeracil and Oteracil Potassium Capsules | Drug | BID,Oral Administration |
|
| Nivolumab | Drug | Q4W,Administered intravenously |
|
| Apatinib | Drug | QD,Oral Administration |
|
| Gemcitabine | Drug | Q4W,Administered intravenously |
|
| DCR | Disease control rate (DCR = CR + PR + SD) | 112 weeks |
| OS | Overall survival (OS) | 112 weeks |
| AEs | Incidence of adverse events | 112 weeks |
| SAEs | Incidence of serious adverse events | 112 weeks |
| Temperatures | Temperatures | 112 weeks |
| Pulse in BPM | Beat per Minute | 112 weeks |
| Blood Pressure | Blood Pressure in mmHg | 112 weeks |
| Weight | Weight in Kg | 112 weeks |
| Height | Height in centimeter | 112 weeks |
| Blood Routine examination | Laboratory tests-Blood Routine examination | 112 weeks |
| Urine Routine test | Laboratory tests-Urine Routine test | 112 weeks |
| Blood biochemistry | Laboratory tests-Blood biochemistry | 112 weeks |
| Coagulation function | Laboratory tests- Coagulation function | 112 weeks |
| LVEF | Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage | 112 weeks |
| HR | 12-lead electrocardiogram (ECG) in HR | 112 weeks |
| RR | 12-lead electrocardiogram (ECG) in RR | 112 weeks |
| PR | 12-lead electrocardiogram (ECG) in PR | 112 weeks |
| QRS | 12-lead electrocardiogram (ECG) in QRS | 112 weeks |
| QT | 12-lead electrocardiogram (ECG) in QT | 112 weeks |
| QTcF | 12-lead electrocardiogram (ECG) in QTcF | 112 weeks |
| ECOG score | Eastern Cooperative Oncology Group score | 112 weeks |
| PK Parameter:Cmax | Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) | 112 weeks |
| PK Parameter:Tmax | PK Parameter:Time of Maximum Observed Concentration (Tmax) | 112 weeks |
| PK Parameter: AUC | PK Parameter: Area Under the Concentration-time Curve(AUC) | 112 weeks |
| PK Parameter: Cmax,ss | PK Parameter: Steady State Maximum Concentration(Cmax,ss) | 112 weeks |
| PK Parameter: Cmin,ss | PK Parameter: Steady State Minimum Concentration(Cmin,ss) | 112 weeks |
| PK Parameter: CLss | PK Parameter: Systemic Clearance at Steady State (CLss) | 112 weeks |
| PK Parameter:Rac | PK Parameter: Accumulation Ratio (Rac) | 112 weeks |
| PK Parameter: t1/2 | PK Parameter: Elimination Half-life (t1/2) | 112 weeks |
| PK Parameter: Vss | PK Parameter: Volume of Distribution at Steady-State (Vss) | 112 weeks |
| PK Parameter: DF | PK Parameter: Degree of Fluctuation (DF) | 112 weeks |
| Immunogenicity of LM-302 | Anti-Drug antibody and Nab (if neccessary) will be tested. | 112 weeks |
| Biomarker correlation | For the detection of CLDN18.2 and PD-L1 | 112 weeks |
| AE/SAE | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 112 weeks |
| Zhejiang University |
| Principal Investigator |
| Rushen Zhao | Zibo Municipal Hospital | Principal Investigator |
| Chunmei Bai | Peking Union Medical College Hospital | Principal Investigator |
| Hongming Pan | Sir Run Run Shaw Hospital | Principal Investigator |
| Jing Dai | Zhongnan Hospital | Principal Investigator |
| Yiping Mou | Zhejiang Provincial People's Hospital | Principal Investigator |
| Haijiao Yan | The First People's Hospital of Changzhou | Principal Investigator |
| Aiping Zhou | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Xianglin Yuan | Tongji Hospital | Principal Investigator |
| Yabin Xia | First Affiliated Hospital of Wannan Medical College | Principal Investigator |
| Mingzhu Huang | Fudan University | Principal Investigator |
| Lixin Wan | Nanyang Central Hospital | Principal Investigator |
| Jun Zhou | Shanghai Gaobo Cancer Hospital | Principal Investigator |
| Youwei Zhang | Xuzhou Central Hospital | Principal Investigator |
| Ning Wu | Shanghai Pudong New District Gongli Hospital | Principal Investigator |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |