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.
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. The trial will be divided into two parts: dose-exploration and indication expansion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
206
Experimental: Anti- PD-1 monoclonal antibody(SCT-I10A)
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGSafety/Tolerability
Incidence of adverse events and outlier of laboratory tests, positive rate of immunogenicity
Time frame: 24 months
Objective response rate (ORR)
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.
Time frame: 24 months
Duration of response (DOR)
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.
Time frame: 24 months
Disease control rate (DCR)
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.
Time frame: 24 months
Progression free survival (PFS)
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.
Time frame: 24 months
Overall survival (OS)
OS is defined as time from first dose of SCT200 until the date of death from any cause.
Time frame: 24 months
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