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

Conditions

1. Advanced Solid Tumors or Lymphoma

Interventions

1. 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 ---

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

Conditions

1. Head and Neck Squamous Cell Carcinoma

Interventions

1. 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 ---

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

Conditions

1. Head and Neck Squamous Cell Carcinoma

Interventions

1. Drug: SCT-I10A+chemo
2. 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 ---

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

Conditions

1. Squamous-cell Non-Small-cell Lung Cancer

Interventions

1. Drug: SCT-I10
2. Drug: Docetaxel
3. 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 ---

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

Conditions

1. Esophageal Squamous Cell Carcinoma
2. Colorectal Cancer

Interventions

1. Biological: SCT-I10A
2. Biological: SCT200
3. 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 ---

The purpose of the study is to assess the safety and effectiveness of SCT-I10A in combination with SCT510 in patients with HCC who have not received prior systemic therapy.

NCT04560894

Conditions

1. Hepatocellular Carcinoma

Interventions

1. Drug: SCT-I10A
2. Drug: SCT510
3. Drug: Sorafenib 200mg

MeSH:Carcinoma Carcinoma, Hepatocellular

HPO:Carcinoma Hepatocellular carcinoma

SCT-I10A in Combination With SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma (HCC): A Multicenter, Randomized, Open-label,Phase 2/3 Trial. --- I10A ---

SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma The purpose of the study is to assess the safety and effectiveness of SCT-I10A in combination with SCT510 in patients with HCC who have not received prior systemic therapy. --- I10A ---

SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma The purpose of the study is to assess the safety and effectiveness of SCT-I10A in combination with SCT510 in patients with HCC who have not received prior systemic therapy. --- I10A --- --- I10A ---

Serum concentration of SCT-I10A and SCT510. --- I10A ---