Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety and Tolerability of Using the SHR-1210 by Advanced Solid Tumor Subjects

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: NCT02721589
Recruitment Status : Active, not recruiting
First Posted : March 29, 2016
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
This is an open-label, single center, non-randomized, dose escalation phase I trial to evaluate safety and tolerability of SHR-1210 in patients with advanced solid tumors The primary objective is to assess safety and tolerability of SHR-1210 and identify recommended phase II doses of SHR-1210 in patients with advanced solid tumors

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: SHR-1210 Phase 1

Detailed Description:

This is an open-label, single center, nonrandomized, dose-escalation Phase 1 study to evaluate safety and tolerability of SHR-1210 in subjects with advanced solid tumors who have failed current standard antitumor therapies.

The safety and tolerability of SHR-1210 will be assessed by ongoing reviews of clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, electrocardiogram (ECG), and adverse events. Evaluations of immune safety will also be conducted (immune-related adverse events (AEs), or labs of autoimmune sera, inflammatory events, and immunogenicity). Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.

Efficacy will be assessed every 8 weeks. The study consists of 3 periods: screening (up to 28 days before the first dose), treatment, and follow-up (up to 3 months after the last dose of study treatment).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-Label, Single Center, Nonrandomized, Dose-Escalation Phase 1 Study to Evaluate Safety and Tolerability of SHR-1210 in Subjects With Advanced Solid Tumors
Actual Study Start Date : April 6, 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Injection SHR-1210
200mg/vial
Drug: SHR-1210
PD-1 antibody
Other Name: INCSHR01210




Primary Outcome Measures :
  1. Dose limited toxicity [ Time Frame: 28 day ]


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female 18-70 years of age.
  2. Subjects diagnosed with histologically or cytologically confirmed solid tumors documented as advanced or metastatic disease. Subjects must be considered relapsed or refractory to standard therapies, have been intolerant to standard therapies, or have refused standard therapy.
  3. ECOG performance status of 0 or 1.
  4. Life expectancy ≥ 12 weeks.
  5. Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1.
  6. Adequate laboratory parameters during the screening period as evidenced by the following:

    1. Absolute neutrophil count ≥ 1.5 × 109/L (1500/mm3)
    2. Platelets ≥ 100 × 109/L (100,000/mm3)
    3. Hemoglobin ≥ 9.0 g/dL (90 g/L)
    4. Albumin (ALB) levels ≥ 2.8 g/dL
    5. Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN)
    6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN); for subjects with liver metastases, ALT and AST ≤ 5 × ULN
    7. Serum creatinine ≤ 1.5 × ULN
  7. Female subjects agree not to be pregnant or lactating from beginning of the study screening through at least 3 months after receiving the last dose of study treatment. Both men and women of reproductive potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy. A highly effective method of contraception is defined as one that results in a low failure rate, that is, less than 1% per year when used consistently and correctly
  8. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

  1. Subjects with any active autoimmune disease or history of autoimmune disease, or history of syndrome that requires systemic steroids or immunosuppressive medications, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Subjects with the following conditions will not be excluded from this study: asthma that requires intermittent use of bronchodilators, hypothyroidism stable on hormone replacement, vitiligo, Graves' disease, or Hashimoto's disease. Additional exceptions may be made with medical monitor approval.
  2. Known history of hypersensitivity to any components of the SHR-1210 formulation.
  3. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. Note: corticosteroids used for the purpose of IV contrast allergy prophylaxis are allowed.
  4. Active central nervous system (CNS) metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease). Subjects with brain or meningeal metastases that were previously treated must be clinically stable (magnetic resonance imaging [MRI] at least 4 weeks apart do not show evidence of new or enlarging metastases) and have discontinued immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for at least 2 weeks before study drug administration.
  5. Uncontrolled clinically significant medical condition, including but not limited to the following: (1) congestive heart failure (New York Health Authority Class > 2), (2) unstable angina, (3) myocardial infarction within the past 12 months, or (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention.
  6. Prior systemic chemotherapy (< 6 weeks if chemotherapy including nitrosoureas or mitomycin), radiotherapy, immunotherapy, hormone therapy, surgery or target therapy within 4 weeks before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (with the exception of any stable chronic toxicities not expected to resolve).
  7. Active infection or an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled).
  8. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease.
  9. Any other medical (eg, pulmonary, metabolic, congenital, endocrinal, or CNS disease), psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results.
  10. Investigational therapy administered within 4 weeks before the first dose of INCSHR01210.
  11. Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation based on institutional guidelines and tests. Testing may include the following: HBV DNA, HCV RNA, hepatitis B surface antigen, or anti-hepatitis B core antibody.

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): NCT02721589


Locations
Layout table for location information
China, Guangdong
Cancer hospital affiliated to Zhongshan University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Layout table for investigator information
Study Director: Yiding Xing, Doctor Jiangsu Hengrui Pharmaceutical Co., LTD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02721589     History of Changes
Other Study ID Numbers: SHR-1210-101
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No