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Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of an Anti-PD-1 mAb for Patients With Advanced Solid Tumors

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: NCT02836834
Recruitment Status : Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Junshi Bioscience Co., Ltd.

Brief Summary:

The primary objective is to assess the safety and tolerability of JS-001 in subjects with various advanced or recurrent malignancies, including solid tumors and lymphomas, and to evaluate its preliminary efficacy.

The secondary objectives are to: 1) characterize the single-dose and multi-dose pharmacokinetic (PK) profile of JS-001, 2) characterize the immunogenicity of JS-001; 3) assess the dose-efficacy relationship of JS-001 single agent, and 4) preliminarily evaluate biomarkers associated with the efficacy of JS-001.

The exploratory objectives include to evaluate the consistency between biomarker detection results of archived tissue and fresh frozen tissue, and to assess the consistency of response using various response criteria (such as irRC, WHO, RECIST and irRECIST).


Condition or disease Intervention/treatment Phase
Lymphoma Lung Cancer Biological: JS001 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection in Patients With Advanced Solid Tumors
Actual Study Start Date : August 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Escalation Cohort
JS001
Biological: JS001
Dose escalation study evaluating three dose levels (1, 3 and 10 mg/kg) of JS-001.Each of the 3 dose levels will use 2 dose schedules: single dose, and repeated doses every 2 weeks. Subjects will be assigned to a dose schedule in the order of study entry.
Other Name: toripalimab, TAB001

Experimental: Expanded cohort 1
The subjects of expanded cohort 1 will use repeated doses every 2 weeks like multiple dose cohorts
Biological: JS001
Dose escalation study evaluating three dose levels (1, 3 and 10 mg/kg) of JS-001.Each of the 3 dose levels will use 2 dose schedules: single dose, and repeated doses every 2 weeks. Subjects will be assigned to a dose schedule in the order of study entry.
Other Name: toripalimab, TAB001

Experimental: Expanded cohort 2
The subjects of expanded cohort 2 will use repeated doses every 2 weeks like multiple dose cohorts
Biological: JS001
Dose escalation study evaluating three dose levels (1, 3 and 10 mg/kg) of JS-001.Each of the 3 dose levels will use 2 dose schedules: single dose, and repeated doses every 2 weeks. Subjects will be assigned to a dose schedule in the order of study entry.
Other Name: toripalimab, TAB001




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 154 days ]

Secondary Outcome Measures :
  1. correlation analysis of PD-L1 expression of tumor and ORR [ Time Frame: 154 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing to sign Informed Consent;
  2. Re-entry into the study is allowed with a second informed consent;
  3. Willing to provide blood sample for biomarker analysis(mandatory). The tissue sample is optional;
  4. A diagnosis of an advanced malignant tumor confirmed by histology or cytology;
  5. No standard of care for the patient;
  6. At least 1 measurable lesion;
  7. Aged 18-65 years;
  8. Anticipated life expectancy of at least 3 months;
  9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
  10. i) At least 4 weeks elapsed since receiving systemic chemotherapy, at least 6 weeks since receiving mitomycin or nitrosoureas, and at least 2 weeks since receiving a tyrosine kinase inhibitor;
  11. At least 4 weeks elapsed since receiving definite radiotherapy, and at least 2 weeks since receiving palliative radiotherapy;
  12. At least 2 weeks since the last dose of systemic steroid therapy (>10 mg/day prednisone or equivalent);
  13. At least 4 weeks since receiving anti-cancer biotherapy;
  14. Recovered from previous treatment related adverse reaction;
  15. willing to use an acceptable contraceptive method;
  16. A negative pregnancy test for female subjects of childbearing potential;

Exclusion Criteria:

  1. Active central nervous system (CNS) metastases and/or carcinomatous meningitis;
  2. Known history of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 2 years, or underwent successful definitive resection of basal or squamous cell carcinoma of the skin, or in situ cervical cancer;
  3. Active, known or suspected autoimmune disease;
  4. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibodies;
  5. Significant medical disease;
  6. Active infection;
  7. Active tuberculosis or history of tuberculosis with one year;
  8. Infection of Human immunodeficiency virus (HIV);
  9. A complication requiring immune-suppression;
  10. Received a live vaccine within 4 weeks prior to first dose of study drug
  11. pleural or abdominal effusion with symptoms;
  12. Drug or alcohol abuse (for subjects in the pharmacokinetic cohorts) ;
  13. evidence of interstitial lung disease;
  14. Active hepatitis B or C, or with significant risk of hepatitis reactivation;
  15. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to monoclonal antibodies or drugs chemically related to the study drug. History of serious hypersensitivity reaction or serious hepatotoxicity related to any drug.

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): NCT02836834


Locations
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China, Beijing
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing, China, 100021
Sponsors and Collaborators
Shanghai Junshi Bioscience Co., Ltd.
Investigators
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Principal Investigator: Yuankai Shi, PhD.MD Cancer Hospital Chinese Academy of Medical Science
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanghai Junshi Bioscience Co., Ltd.
ClinicalTrials.gov Identifier: NCT02836834    
Other Study ID Numbers: Junshi-JS001-YKZL-I
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shanghai Junshi Bioscience Co., Ltd.:
immunotherapy
check point inhibitor
PD-1 antibody
solid tumor
lymphoma
phase 1 trial
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases