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Report for Clinical Trial NCT03821363

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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
MeSH:Lymphoma
HPO:Lymphoma

1 Interventions

Name: SCT-I10A

Description: Experimental: Anti- PD-1 monoclonal antibody(SCT-I10A)
Type: Biological
Group Labels: 3

High dose group Low dose group Middle dose group


Primary Outcomes

Description: Incidence of adverse events and outlier of laboratory tests, positive rate of immunogenicity

Measure: Safety/Tolerability

Time: 24 months

Secondary 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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

Purpose: Treatment

Allocation: Non-Randomized

Sequential Assignment


There is one SNP

SNPs


1 I10A

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 ---



HPO Nodes


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