We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of SHR-1501 in Patients With Advanced 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: NCT04025957
Recruitment Status : Unknown
Verified July 2020 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Recruiting
First Posted : July 19, 2019
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in patients with advanced malignancies .

Condition or disease Intervention/treatment Phase
Advanced Malignancies Drug: SHR-1501 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study on Tolerance, Safety and Pharmacokinetics of SHR-1501 in Patients With Advanced Malignancies.
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: SHR-1501 dose escalation
SHR-1501 given subcutaneously
Drug: SHR-1501
Administered subcutaneously

Experimental: SHR-1501 dose expansion
SHR-1501 given subcutaneously
Drug: SHR-1501
Administered subcutaneously




Primary Outcome Measures :
  1. Dose-limiting toxicity [ Time Frame: Approximately 2 years ]
    Dose-limiting toxicity in patients with advanced tumors treated by SHR-1501.

  2. Maximum tolerated dose [ Time Frame: Approximately 2 years ]
    Maximum tolerated dose in patients with advanced tumors treated by SHR-1501.

  3. Adverse event/Serious adverse event [ Time Frame: Approximately 2 years ]
    Incidence/severity of adverse events/serious adverse events (rated based on CTC AE v5.0)


Secondary Outcome Measures :
  1. Pharmacokinetic (PK) [ Time Frame: Approximately 2 years ]
    Single dose: maximum concentration (Cmax)

  2. Pharmacokinetic (PK) [ Time Frame: Approximately 2 years ]
    Single dose: time to maximum concentration (Tmax)

  3. Pharmacokinetic (PK) [ Time Frame: Approximately 2 years ]
    Single dose: areas under the concentration-time curve (AUClast and AUCinf)

  4. Pharmacokinetic (PK) [ Time Frame: Approximately 2 years ]
    Single dose: half-life (t1/2)

  5. Pharmacokinetic (PK) [ Time Frame: Approximately 2 years ]
    Single dose: clearance (CL)

  6. Pharmacokinetic (PK) [ Time Frame: Approximately 2 years ]
    Single dose: mean residence time (MRT)

  7. Pharmacokinetic (PK) [ Time Frame: Approximately 2 years ]
    Single dose: volume at steady state (Vss)

  8. Pharmacokinetic (PK) [ Time Frame: Approximately 2 years ]
    Multiple doses (at steady state, if applicable): maximum concentration at steady state (Css_max)

  9. Pharmacokinetic (PK) [ Time Frame: Approximately 2 years ]
    Multiple doses (at steady state, if applicable):time to maximum concentration (Tmax)

  10. Pharmacokinetic (PK) [ Time Frame: Approximately 2 years ]
    Multiple doses (at steady state, if applicable):area under the concentration-time curve at steady state (AUCss)

  11. Pharmacokinetic (PK) [ Time Frame: Approximately 2 years ]
    Multiple doses (at steady state, if applicable): t1/2

  12. Pharmacokinetic (PK) [ Time Frame: Approximately 2 years ]
    Multiple doses (at steady state, if applicable):steady-state minimum concentration at steady state (Css_min)

  13. Pharmacokinetic (PK) [ Time Frame: Approximately 2 years ]
    Multiple doses (at steady state, if applicable):average concentration at steady state(Cavg)

  14. Pharmacokinetic (PK) [ Time Frame: Approximately 2 years ]
    Multiple doses (at steady state, if applicable):accumulation ratio (Rac)

  15. Immune-related biomarkers [ Time Frame: Approximately 2 years ]
    indicated by the count of CD8+ T-lymphocytes in peripheral blood at scheduled post-dose time points.

  16. Immune-related biomarkers [ Time Frame: Approximately 2 years ]
    indicated by the percentage of CD8+ T-lymphocytes in peripheral blood at scheduled post-dose time points.

  17. Immune-related biomarkers [ Time Frame: Approximately 2 years ]
    indicated by the count of natural killer (NK) cells in peripheral blood at scheduled post-dose time points.

  18. Immune-related biomarkers [ Time Frame: Approximately 2 years ]
    indicated by the percentage of natural killer (NK) cells in peripheral blood at scheduled post-dose time points.

  19. Objective response rate [ Time Frame: Approximately 2 years ]
    Percentage of participants with CR or PR.

  20. Disease control rate [ Time Frame: Approximately 2 years ]
    Percentage of participants with CR or PR or SD.

  21. Immunogenicity [ Time Frame: Approximately 2 years ]
    The immunogenicity of SHR-1501 single drug. The indicator includes number of participants with anti-drug antibody positive or neutralizing antibody positive.



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:

  • All Patients All patients must meet all the following criteria to be eligible to participate:

    1. Voluntarily participate in this clinical study, understand the research procedure and be able to sign informed consent in writing;
    2. Subjects must be willing and able to follow the research protocol;
    3. Aged 18-70 years old when the informed consent form is signed;
    4. Have a histologically or cytologically confirmed diagnosis of advanced or metastatic tumor malignancy;
    5. Patients' malignancies must be relapsed or refractory to standard treatment, or patients cannot tolerate standard treatment, or patients have actively refused standard therapy;
    6. Eastern Cooperative Oncology Group ECOG PS score of 0-1;
    7. Have a life expectancy of ≥ 12 weeks;
    8. Adequate organ function defined according to the protocol, These results should be completed within 14 days prior to the first study treatment:
    9. Non-surgically sterilized women of childbearing age or male subjects are required to consent to the use of at least one medically approved contraceptive (eg intrauterine devices, contraceptives or condoms) is performed during the study treatment period and within 3 months of the end of the study treatment period.

Exclusion Criteria:

  1. Patients with cancerous meningitis (ie meningeal metastasis);
  2. Patients with active central nervous system (CNS) metastasis.
  3. Spinal cord compression that cannot be radically treated with surgery and/or radiotherapy cannot be enrolled.
  4. Patients with double primary cancers;
  5. Patients with a history of autoimmune diseases;
  6. Significant clinical significance in the history of cardiovascular disease;
  7. Arterial/venous thrombosis events such as cerebrovascular accidents deep vein thrombosis and pulmonary embolism within 6 months prior to first administration;
  8. Have a history of immunodeficiency including HIV infection;
  9. Active hepatitis B or hepatitis C patients;
  10. Any disease or symptom that is not appropriate for inclusion in this study determined by the investigator.;
  11. Patients have undergone major surgery within 28 days prior to the first dose (except for diagnostics);
  12. Those who used a live attenuated vaccine within 4 weeks prior to the first dose or expect a live attenuated vaccine during the study period;
  13. Those who received other clinical trials within 4 weeks prior to the first study;
  14. Those who received systemic immunosuppressive therapy within 2 weeks prior to the first study dose;
  15. Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation;
  16. A history of severe allergic reactions to other monoclonal antibody/fusion protein drugs;
  17. Mental illness, alcohol abuse, drug abuse or substance abuse;
  18. Any disease or condition that causes reasonable suspicion to prohibit the use of the study drug or affect the interpretation of the study results or the patient is at high risk of treatment complications (any other disease, metabolic disorder, physical examination results or laboratory tests abnormalities);
  19. Pregnant or lactating women or women planning to become pregnant during the study.

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): NCT04025957


Contacts
Layout table for location contacts
Contact: Jianjun Zou, MD 021-68868570 zoujianjun@hrglobe.cn
Contact: Wei Shi, MD 021-68868570 shiwei@hrglobe.cn

Locations
Layout table for location information
China
Cancer hospital, Chinese academy of medical sciences Recruiting
Beijing, China, 100021
Contact: Jing Huang, MD    010-67781331    huangjingwg@163.com   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Layout table for investigator information
Study Director: Jing Huang, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Layout table for additonal information
Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04025957    
Other Study ID Numbers: SHR-1501-I-102
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms