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Safety, Tolerability, Pharmacokinetics and Efficacy of SCT-I10A in Patients With Advanced Solid Tumors or Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821363
Recruitment Status : Unknown
Verified July 2018 by Sinocelltech Ltd..
Recruitment status was:  Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Sinocelltech Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors or Lymphoma Biological: SCT-I10A Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recombinant Humanized Anti- PD-1 Monoclonal Antibody(SCT-I10A) in Patients With Advanced Solid Tumors or Lymphoma :a Phase Ⅰ, Open-label, Multicenter Study
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Low dose group
SCT-I10A will be administered at a dose of 60mg, Q3W up to 24 months.
Biological: SCT-I10A
Experimental: Anti- PD-1 monoclonal antibody(SCT-I10A)

Experimental: Middle dose group
SCT-I10A will be administered at a dose of 200mg, Q3W up to 24 months.
Biological: SCT-I10A
Experimental: Anti- PD-1 monoclonal antibody(SCT-I10A)

Experimental: High dose group
SCT-I10A will be administered at a dose of 600mg, Q3W up to 24 months.
Biological: SCT-I10A
Experimental: Anti- PD-1 monoclonal antibody(SCT-I10A)




Primary Outcome Measures :
  1. Safety/Tolerability [ Time Frame: 24 months ]
    Incidence of adverse events and outlier of laboratory tests, positive rate of immunogenicity


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 24 months ]
    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.

  2. Duration of response (DOR) [ Time Frame: 24 months ]
    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.

  3. Disease control rate (DCR) [ Time Frame: 24 months ]
    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.

  4. Progression free survival (PFS) [ Time Frame: 24 months ]
    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.

  5. Overall survival (OS) [ Time Frame: 24 months ]
    OS is defined as time from first dose of SCT200 until the date of death from any cause.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to provide written informed consent before screening;
  • Males or females. Aged 18 to 75 years old;
  • Life expectancy≥12 weeks before starting treatment (clinical assessment);
  • With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
  • Histologically or cytologically confirmed advanced solid tumor or lymphoma;
  • Advanced solid tumor or lymphoma with standard treatment failed or no effective therapy;
  • According to RECIST 1.1 or Lugano 2014 criteria, patients must have at least one measurable lesion that can be accurately assessed;
  • Adequate organ and bone marrow function as defined below:

Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 2.5 times ULN, or less than/equal to 5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 times ULN; Serum creatinine less than/equal to 1.5 times ULN or Ccr>50ml/min; Thyroid stimulating hormone (TSH) hormone levels less than/equal to ULN.

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). Within 6 weeks prior to the first dose of study drug, patients have been treated with biological products, nitrosourea or mitomycin C;
  • Within 2 weeks prior to the first dose of study drug, patients have received corticosteroids or other immunosuppressive agents;
  • Within 4 weeks prior to the first dose of study drug, patients have received live attenuated vaccine (LAV), or who planned to use LAV during the study period;
  • Within 4 weeks prior to the first dose of study drug, patients have received major surgery, or had wounds, ulcers or fractures that haven't healed;
  • 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 CTCAEv4.03;
  • Patient with cerebrospinal meningitis metastasis or central nervous system metastasis with untreated or uncontrolled with other treatment;
  • Patients with an active, known or suspected autoimmune disease or a history of autoimmune disease;
  • Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Within 6 months prior to study, patients had uncontrolled concurrent diseases, including but not limited to acute myocardial infarction, unstable angina pectoris, stroke, or transient ischemic attack, congestive heart failure (NYHA, greater than II), left ventricular ejection fraction (LVEF) <50%, and with related heart disease. Patients with chronic or acute disease, psychological or psychiatric disorders, laboratory abnormalities which may affect subject compliance and outcomes in this clinical study;
  • Patients with HIV, active hepatitis B (HBV DNA≥104 copies/ml) or active hepatitis C (HCV RNA≥103 copies/ml), etc.;
  • Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or CT or MRI reminder ILD.
  • Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);
  • Patients with other primary malignancies;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821363


Contacts
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Contact: jianming xu, MD +8613910866712 jmxu2003@163.com

Locations
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China, Beijing
The Fifth Medical Center of PLA General Hospital Recruiting
Beijing, Beijing, China, 100071
Contact: jianming xu, MD    +8613910866712    jmxu2003@163.com   
Sponsors and Collaborators
Sinocelltech Ltd.
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Responsible Party: Sinocelltech Ltd.
ClinicalTrials.gov Identifier: NCT03821363    
Other Study ID Numbers: SCT-I10A-X101
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sinocelltech Ltd.:
Neoplasms
Solid Tumors
Lymphoma
PD-1
SCT-I10A
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases