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A Study for PD-1 Antibody JS001 in MSI-H Advanced or Recurrent Colorectal Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04118933
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Xu jianmin, Fudan University

Tracking Information
First Submitted Date  ICMJE October 2, 2019
First Posted Date  ICMJE October 8, 2019
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE July 17, 2019
Estimated Primary Completion Date July 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2019)
objective response rate [ Time Frame: 12 Weeks from the drug firstly being taken ]
The 12 week objective response will be measured according to RECIST v1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study for PD-1 Antibody JS001 in MSI-H Advanced or Recurrent Colorectal Cancer
Official Title  ICMJE An Exploratory Study for PD-1 Antibody JS001 in Participants With Microsatellite Instability-high (MSI-H) Advanced or Recurrent Colorectal Cancer
Brief Summary To observe the efficacy of PD-1 antibody JS001 in the treatment of participants with microsatellite instability-high (MSI-H) advanced or recurrent colorectal cancer, so as to provide sufficient evidence for MSI-H as a biomarker of PD-1/PD-L1 inhibitor.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: JS001
JS001 240mg, Q3W
Study Arms  ICMJE Experimental: MSI-H advanced colorectal cancer
Intervention: Drug: JS001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 5, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 17, 2021
Estimated Primary Completion Date July 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fully understand the study and sign informed consent voluntarily;
  • Histologically confirmed advanced or recurrent colorectal cancer, and MSI detection identified MSI-H;
  • Patients who have previously received first-line or above chemotherapy or targeted therapy and failed to the treatment or experienced recurrence;
  • At least one measurable lesion (RECIST 1.1);
  • Agree to provide tumor tissue samples and Pathology reports related to the specimens;
  • Aged 18 to 75 years, gender not limited;
  • Eastern Cooperative Oncology Group(ECOG) performance status(PS) 0-1; 8. Expected survival ≥3 months;
  • Laboratory test values must meet the following standards within 7 days before enrollment;
  • Women of reproductive age must confirm that the serum pregnancy test is negative and agree to use effective contraceptive measures during the study drug use

Exclusion Criteria:

  • Uncontrolled or symptomatic hypercalcemia;
  • Had major surgery or had not fully recovered from previous surgery within 4 weeks before enrollment;
  • central nervous system(CNS) metastases;
  • Bone metastases;
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently) allow the patient to have a catheter indwelling;
  • Having a history of idiopathic pulmonary fibrosis, organic pneumonia;
  • Uncontrolled active infection, including but not limited to acute pneumonia;
  • Have other malignant tumors at the same time;
  • The patient has any active autoimmune diseases or a history of autoimmune diseases;
  • Liver diseases of known clinical significance, including active viral viral hepatitis, alcoholic hepatitis or other hepatitis, cirrhosis, fatty liver and hereditary liver diseases.
  • Previous use of anti-PD-1 antibody, anti-PD-l1 antibody, anti-PD-l2 antibody or anti-CTLA-4 antibody;
  • Patients with active tuberculosis (TB);
  • Received systemic immunosuppressive within 4 weeks prior to day 1 of the first cycle;
  • Pregnancy test positive;
  • Known human immunodeficiency virus (HIV) infection;
  • A history of severe allergy, anaphylaxis or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins;
  • Those who are known to be allergic to biological drugs produced by hamster ovary cells in China, or to citric acid monohydrate, sodium citrate dihydrate, mannitol and polysorbate (components of the experimental drugs);
  • Patients who have previously received allogeneic stem cells or parenchymal organ transplantation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jianmin Xu, MD +8613501984869 xujmin@aliyun.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04118933
Other Study ID Numbers  ICMJE K19406-JS001-ISS-141
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xu jianmin, Fudan University
Study Sponsor  ICMJE Xu jianmin
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fudan University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP