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

Sponsor
Xu jianmin (Other)
Overall Status
Unknown status
CT.gov ID
NCT04118933
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Exploratory Study for PD-1 Antibody JS001 in Participants With Microsatellite Instability-high (MSI-H) Advanced or Recurrent Colorectal Cancer
Actual Study Start Date :
Jul 17, 2019
Anticipated Primary Completion Date :
Jul 17, 2020
Anticipated Study Completion Date :
Jul 17, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: MSI-H advanced colorectal cancer

Drug: JS001
JS001 240mg, Q3W

Outcome Measures

Primary Outcome Measures

  1. objective response rate [12 Weeks from the drug firstly being taken]

    The 12 week objective response will be measured according to RECIST v1.1

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Hospital Shanghai Shanghai China 200000

Sponsors and Collaborators

  • Xu jianmin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xu jianmin, Deputy director of the colorectal cancer center, Fudan University
ClinicalTrials.gov Identifier:
NCT04118933
Other Study ID Numbers:
  • K19406-JS001-ISS-141
First Posted:
Oct 8, 2019
Last Update Posted:
Oct 8, 2019
Last Verified:
Oct 1, 2019
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
Additional relevant MeSH terms:
Colorectal Neoplasms

Study Results

No Results Posted as of Oct 8, 2019