SNPMiner Trials (Home Page)
Report for Mutation I10A
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 5 clinical trials
Clinical Trials
1 Recombinant Humanized Anti- PD-1 Monoclonal Antibody（SCT-I10A） in Patients With Advanced Solid Tumors or Lymphoma :a Phase Ⅰ, Open-label, Multicenter Study
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of recombinant humanized anti- PD-1 monoclonal antibody（SCT-I10A）in patients with advanced solid tumors or lymphoma treated after failure of standard therapy.
NCT03821363 Advanced Solid Tumors or Lymphoma Biological: SCT-I10A MeSH:Lymphoma
HPO:Lymphoma
Safety, Tolerability, Pharmacokinetics and Efficacy of SCT-I10A in Patients With Advanced Solid Tumors or Lymphoma The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of recombinant humanized anti- PD-1 monoclonal antibody（SCT-I10A）in patients with advanced solid tumors or lymphoma treated after failure of standard therapy. --- I10A ---
Exclusion Criteria: - Patients who are allergic to analogue of SCT-I10A and/or its inactive ingredients; - Patients have been treated with anti-PD-L1 and anti-PD-1 antibody; - Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices; - Within 4 weeks prior to the first dose of study drug, patients have received anti-tumor drugs (such as chemotherapy, endocrine therapy, targeted therapy, immune therapy, tumor embolization). --- I10A ---
Advanced Solid Tumors or Lymphoma Lymphoma This open label, multicenter phase I study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in advanced solid tumors or lymphoma treated with anti- PD-1 monoclonal antibody SCT-I10A. --- I10A ---
Primary Outcomes
Description: Incidence of adverse events and outlier of laboratory tests, positive rate of immunogenicity
Measure: Safety/Tolerability Time: 24 monthsSecondary Outcomes
Description: ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 or Lugano 2014 criteria during trial treatment.
Measure: Objective response rate (ORR) Time: 24 monthsDescription: DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1 or Lugano 2014 criteria, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
Measure: Duration of response (DOR) Time: 24 monthsDescription: PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 or Lugano 2014 criteria.
Measure: Disease control rate (DCR) Time: 24 monthsDescription: PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 or Lugano 2014 criteria.
Measure: Progression free survival (PFS) Time: 24 monthsDescription: OS is defined as time from first dose of SCT200 until the date of death from any cause.
Measure: Overall survival (OS) Time: 24 months2 A Phase II, Multicenter, Single-arm, Open-label Study of SCT-I10A in Patients With Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma Who Progressed on or After Platinum-based Chemotherapy
The objective of this study is to evaluate the efficacy and safety of SCT-I10A for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma who progressed on or after platinum-based chemotherapy
NCT04146181 Head and Neck Squamous Cell Carcinoma Drug: PD-1 MeSH:Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck
HPO:Carcinoma Squamous cell carcinoma
A Phase II, Multicenter, Single-arm, Open-label Study of SCT-I10A in Patients With Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma Who Progressed on or After Platinum-based Chemotherapy. --- I10A ---
Safety and Efficacy of SCT-I10A in Head and Neck Squamous Cell Carcinoma The objective of this study is to evaluate the efficacy and safety of SCT-I10A for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma who progressed on or after platinum-based chemotherapy ORR. --- I10A ---
Safety and Efficacy of SCT-I10A in Head and Neck Squamous Cell Carcinoma The objective of this study is to evaluate the efficacy and safety of SCT-I10A for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma who progressed on or after platinum-based chemotherapy ORR. --- I10A --- --- I10A ---
Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck This is an open label, single-arm and multicenter phase II study designed to evaluate Objective Response Rate (ORR) of SCT-I10A for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma who progressed on or after platinum-based chemotherapy. --- I10A ---
Primary Outcomes
Description: ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment
Measure: ORR Time: 1 year3 SCT-I10A Combined With Standard Chemotherapy Versus Placebo Combined With Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC): A Phase III, Multicenter, Randomized, Double-blinded Trial
The objective of this study is to evaluate the efficacy and safety of SCT-I10A plus standard chemotherapy for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma
NCT04146402 Head and Neck Squamous Cell Carcinoma Drug: SCT-I10A+chemo Drug: Placebos+chemo MeSH:Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck
HPO:Carcinoma Squamous cell carcinoma
SCT-I10A Combined With Standard Chemotherapy Versus Placebo Combined With Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC): A Phase III, Multicenter, Randomized, Double-blinded Trial. --- I10A ---
SCT-I10A Plus Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma The objective of this study is to evaluate the efficacy and safety of SCT-I10A plus standard chemotherapy for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma Overall survival. --- I10A ---
SCT-I10A Plus Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma The objective of this study is to evaluate the efficacy and safety of SCT-I10A plus standard chemotherapy for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma Overall survival. --- I10A --- --- I10A ---
OS is defined as time from first dose of SCT-I10A until the date of death from any cause. --- I10A ---
PFS is defined as the time from first dose of SCT-I10A until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criter. --- I10A ---
Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck This is a Phase III, multicenter, randomized, double-blinded trial designed to evaluate Overall survival (OS) of SCT-I10A combined with standard chemotherapy in patients living with Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma --- I10A ---
Primary Outcomes
Description: OS is defined as time from first dose of SCT-I10A until the date of death from any cause
Measure: Overall survival Time: 1 yearSecondary Outcomes
Description: PFS is defined as the time from first dose of SCT-I10A until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criter
Measure: Progression free survival Time: 1 yearDescription: ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment
Measure: Objective response rate Time: 1 year4 A Multicenter Randomized Double-blinded Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of SCT-I10A or Placebo Plus Docetaxel in Treating Advanced Squamous Non-small Cell Lung Cancer
This is a phase 3 double-blinded randomized multicenter clinical trial of SCT-I10A or placebo plus docetaxel with previously treated squamous cell non-small cell lung cancer patients. The main endpoint is to compare the overall survival (OS) of these two regimens above.
NCT04171284 Squamous-cell Non-Small-cell Lung Cancer Drug: SCT-I10 Drug: Docetaxel Drug: Placebo MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma
A Multicenter Randomized Double-blinded Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of SCT-I10A or Placebo Plus Docetaxel in Treating Advanced Squamous Non-small Cell Lung Cancer. --- I10A ---
SCT-I10A or Placebo Plus Docetaxel With Previously Treated Squamous Cell Non-small Cell Lung Cancer This is a phase 3 double-blinded randomized multicenter clinical trial of SCT-I10A or placebo plus docetaxel with previously treated squamous cell non-small cell lung cancer patients. --- I10A ---
SCT-I10A or Placebo Plus Docetaxel With Previously Treated Squamous Cell Non-small Cell Lung Cancer This is a phase 3 double-blinded randomized multicenter clinical trial of SCT-I10A or placebo plus docetaxel with previously treated squamous cell non-small cell lung cancer patients. --- I10A --- --- I10A ---
The concentration of anti-SCT-I10A antibodies in the serum of subjects. --- I10A ---
The concentration of anti-SCT-I10A antibodies in the serum of subjects during or after the study treatments will be measured, its level could indicate the immunogenicity of SCT-I10A.. --- I10A ---
The concentration of anti-SCT-I10A antibodies in the serum of subjects during or after the study treatments will be measured, its level could indicate the immunogenicity of SCT-I10A.. --- I10A --- --- I10A ---
Hence, we developed a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor monoclonal antibody (SCT-I10A) which inhibits the interaction between PD-1 and its ligands results in the reactivation of active T cell and finally leads to caner immunotherapy. --- I10A ---
We are now carrying out a phase 3 clinical trial to determine whether SCT-I10A plus docetaxel surpass docetaxel monotherapy with previously treated squamous-cell NSCLC patients. --- I10A ---
240 subjects would be treated with SCT-I10A plus docetaxel in the experimental arm while 120 subjects would be treated with placebo plus docetaxel in the active comparator arm. --- I10A ---
Primary Outcomes
Description: OS is the time from the date of randomization to death due to any cause.
Measure: Overall survival Time: Up to approximately 3 yearsSecondary Outcomes
Description: PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
Measure: PFS Time: Up to approximately 3 yearsDescription: overall survival rate from the date of randomization till the 6 months,12 months and 18 months
Measure: OSR of 6 months, 12 months and 18 moths Time: Each subject that randomized will be followed up for 18 months to measure the OSR.Description: ORR is the proportion of subjects with CR or PR based on RECIST v1.1.
Measure: ORR Time: Up to approximately 3 yearsDescription: DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Measure: DOR Time: Up to approximately 3 yearsDescription: DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST v1.1.
Measure: DCR Time: Up to approximately 3 yearsDescription: The concentration of anti-SCT-I10A antibodies in the serum of subjects during or after the study treatments will be measured, its level could indicate the immunogenicity of SCT-I10A.
Measure: The concentration of anti-SCT-I10A antibodies in the serum of subjects Time: Up to approximately 3 yearsDescription: The expression level of PD-L1 of the subjects would be measure by immunohistochemical detection. The results would be used to analyze the correlation of PD-L1 level and outcomes including primary and secondary endpoints including OS, PFS, OSR, ORR, DOR and DCR.
Measure: The expression level of PD-L1 of subjects' specimens Time: Up to approximately 3 yearsDescription: European Organisation for Research and Treatment of Cancer (EORTC) cancer-specific quality of life questionnaire (EORTC QLQ-C30) will be applied in all subjects to collect the score of 30 items of subjects before and after study treatments. For the items from one to twenty-eight, the minimum and maximum scores are 28 and 112 respectively and the higher score means a worse outcome. For the items from twenty-nine to thirty, the minimum and maximum raw scores are 2 and 14 respectively and the higher score means a better outcome. Further analysis could be done based on the calculation.
Measure: Cancer-specific quality of life of the regimens treated subjects Time: Up to approximately 3 yearsDescription: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) will be applied in all subjects to collect the score of 13 specific typical symptoms of lung cancer patients before and after study treatments. The minimum and maximum raw scores are 12 and 52 respectively, the higher score means a worse outcome.
Measure: Lung cancer-specific quality of life of the regimens treated subjects Time: Up to approximately 3 years5 To Evaluate Safety and Efficacy of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in Advanced Esophageal Squamous Cell Carcinoma and Colorectal Cancer: a Phase Ⅰb, Open-label, Multicenter Study
The purpose of this study is to evaluate the safety and efficacy of SCT-I10A combined SCT200 or SCT-I10A combined SCT200 plus chemotherapy in advanced esophageal squamous cell carcinoma and colorectal cancer
NCT04229537 Esophageal Squamous Cell Carcinoma Colorectal Cancer Biological: SCT-I10A Biological: SCT200 Other: Chemotherapy MeSH:Carcinoma Colorectal Neoplasms Carcinoma, Squamous Cell Esophageal Squamous Cell Carcinoma
HPO:Carcinoma Neoplasm of the large intestine Squamous cell carcinoma
To Evaluate Safety and Efficacy of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in Advanced Esophageal Squamous Cell Carcinoma and Colorectal Cancer: a Phase Ⅰb, Open-label, Multicenter Study. --- I10A ---
To Evaluate Safety and Efficacy of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in Advanced Esophageal Squamous Cell Carcinoma and Colorectal Cancer: a Phase Ⅰb, Open-label, Multicenter Study. --- I10A --- --- I10A ---
Study of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in ESCC and CRC The purpose of this study is to evaluate the safety and efficacy of SCT-I10A combined SCT200 or SCT-I10A combined SCT200 plus chemotherapy in advanced esophageal squamous cell carcinoma and colorectal cancer Rate of adverse events. --- I10A ---
Study of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in ESCC and CRC The purpose of this study is to evaluate the safety and efficacy of SCT-I10A combined SCT200 or SCT-I10A combined SCT200 plus chemotherapy in advanced esophageal squamous cell carcinoma and colorectal cancer Rate of adverse events. --- I10A --- --- I10A ---
Study of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in ESCC and CRC The purpose of this study is to evaluate the safety and efficacy of SCT-I10A combined SCT200 or SCT-I10A combined SCT200 plus chemotherapy in advanced esophageal squamous cell carcinoma and colorectal cancer Rate of adverse events. --- I10A --- --- I10A --- --- I10A ---
Study of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in ESCC and CRC The purpose of this study is to evaluate the safety and efficacy of SCT-I10A combined SCT200 or SCT-I10A combined SCT200 plus chemotherapy in advanced esophageal squamous cell carcinoma and colorectal cancer Rate of adverse events. --- I10A --- --- I10A --- --- I10A --- --- I10A ---
Exclusion Criteria: - Patients who were allergic to analogue of SCT-I10A/SCT200 and/or its inactive ingredients, Patients who were allergic to Capecitabine and/or Oxaliplatin were also excluded in cohort3; - Patients have been treated with anti-PD-L1/PD-L2 or anti-PD-1, EGFR antibody or EGFR-TKI; - Within 4 weeks prior to the first dose of study drug, patients have received anti-tumor drugs (such as chemotherapy, endocrine therapy, targeted therapy, immune therapy, tumor embolization). --- I10A ---
HCV RNA [quantitative] is detected); - Prior to the first dose of study drug, patients had toxicity due to previous anti-tumor treatment, which hasn't return to Grade 0-1 according to the NCI CTCAE v5.0; - Has known with alcohol or drug addiction; - Pregnant or lactating women; - Patients who were not willing to accept effective contraceptive measures during treatment and within 6 months after treatment; - Subjects who are considered not suitable for the study by investigator Esophageal Squamous Cell Carcinoma Colorectal Cancer Carcinoma Colorectal Neoplasms Carcinoma, Squamous Cell Esophageal Squamous Cell Carcinoma This is a open label, multicenter, phase III study designed to evaluate the safety and efficacy in advanced esophageal squamous cell carcinoma and colorectal cancer treated with SCT-I10A combined SCT200 or SCT-I10A combined SCT200 plus chemotherapy. --- I10A ---
HCV RNA [quantitative] is detected); - Prior to the first dose of study drug, patients had toxicity due to previous anti-tumor treatment, which hasn't return to Grade 0-1 according to the NCI CTCAE v5.0; - Has known with alcohol or drug addiction; - Pregnant or lactating women; - Patients who were not willing to accept effective contraceptive measures during treatment and within 6 months after treatment; - Subjects who are considered not suitable for the study by investigator Esophageal Squamous Cell Carcinoma Colorectal Cancer Carcinoma Colorectal Neoplasms Carcinoma, Squamous Cell Esophageal Squamous Cell Carcinoma This is a open label, multicenter, phase III study designed to evaluate the safety and efficacy in advanced esophageal squamous cell carcinoma and colorectal cancer treated with SCT-I10A combined SCT200 or SCT-I10A combined SCT200 plus chemotherapy. --- I10A --- --- I10A ---
Primary Outcomes
Description: Including adverse events and safety of laboratory tests
Measure: Rate of adverse events Time: 24 monthsSecondary Outcomes
Description: ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 or Lugano 2014 criteria during trial treatment
Measure: Objective response rate (ORR) Time: 24 monthsDescription: DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1 or Lugano 2014 criteria, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first
Measure: Duration of response (DOR) Time: 24 monthsDescription: The achievement of any a stable response（SD）, partial response (PR) or complete response (CR), according to RECIST v1.1 or Lugano 2014 criteria
Measure: Disease control rate (DCR) Time: 24 monthsDescription: PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 or Lugano 2014 criteria
Measure: Progression free survival (PFS) Time: 24 monthsDescription: OS is defined as time from first dose of SCT200 until the date of death from any cause
Measure: Overall survival (OS) Time: 24 months