There is one clinical trial.
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.
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 ---
Description: Incidence of adverse events and outlier of laboratory tests, positive rate of immunogenicity
Measure: Safety/Tolerability Time: 24 monthsDescription: 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 months