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SHR-1701 in Subjects With Metastatic or Locally 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. 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: NCT03774979
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE December 13, 2018
Last Update Posted Date July 29, 2020
Actual Study Start Date  ICMJE January 24, 2019
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2020)
  • Dose escalation part： Safety and tolerability of SHR-1701 in advanced malignancies. [ Time Frame: Up to 3/4 weeks. ]
    Number of Subjects who occurs dose-limiting toxicity (DLTs).
  • Clinical expansion Part: Objective Response Rate（ORR） [ Time Frame: Up to 6 weeks ]
    ORR is define as the percentage of participants in the analysis population who havea Complete Response(CR:Disappearance of all target lesions)or a Partial Response(PR :30% decrease in the sum of diameter of target lesions) per RECIST 1.1.
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2018)		 Dose-escalation Part: Safety and tolerability profile of SHR-1701 [ Time Frame: Up to 3 week ]
Number of Subjects with dose-limiting toxicity (DLTs)/AEs
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2020)
  • Clinical expansion Part: Safety of SHR-1701 [ Time Frame: Up to 4 weeks after last treatment ]
    Number of subjects who occurs treatment-related Adverse Events(AEs）
  • Clinical expansion Part: Disease Control Rate(DCR) per RECIST1.1 [ Time Frame: Up to 6 weeks ]
    DCR is define as the percentage of participants in the analysis population who have a CR,PR or SD per RECIST 1.1.
  • Clinical expansion Part: Duration of Response （DOR）per RECIST1.1 [ Time Frame: Up to 6 weeks ]
    DOR is define as the time from first documented evidence of CR or PR until disease progression per RECIST 1.1
  • Clinical expansion Part:Progression-free survival(PFS) per RECIST1.1 [ Time Frame: 12months (anticipated) ]
    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
  • Dose-escalation Part: Maximun serum concentration (Cmax) of SHR-1701 [ Time Frame: Up to 4 weeks after last treatment ]
  • Dose-escalation Part:Area under the concentration time curve (AUC) of SHR-1701 [ Time Frame: Up to 4 weeks after last treatment ]
  • Dose-escalation Part: Terminal half life (t1/2) of SHR-1701 [ Time Frame: Up to 4 weeks after last treatment ]
  • Dose-escalation Part: Pharmacodynamic features of SHR-1701 [ Time Frame: 12months(anticipated) ]
    SHR-1701 receptor occupation
  • Dose-escalation Part: Overall response reate (ORR) of SHR-1701 [ Time Frame: 12months(anticipated) ]
    According to RECIST 1.1&imRECIST, BOR is defined as sum of complete response and partial response.
  • Dose-escalation Part: Disease control reate (DCR) of SHR-1701 [ Time Frame: 12months(anticipated) ]
    According to RECIST 1.1&imRECIST, BOR is defined as sum of complete response partial response, and stable disease.
  • Dose-escalation Part: Progression free survival (PFS) of SHR-1701 [ Time Frame: 12months (anticipated) ]
    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 & imRECIST based on blinded independent central review or death due to any cause, whichever occurs first.
  • Dose-escalation Part: Overall survival (OS) of SHR-1701 [ Time Frame: 12months(anticipated) ]
    OS is defined as the time from randomization to death due to any cause.
  • Dose-escalation Part: Immunogenicity of SHR-1701 [ Time Frame: 12months(anticipated) ]
    Anti SHR-1701 receptor antibodies (ADA)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors
Official Title  ICMJE A Phase I, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications
Brief Summary The main purpose of this study is to assess the safety and tolerability of SHR-1701 at different dose levels. Study consists of dose-escalation part and an expansion part in subjects with metastatic or locally advanced solid tumors.
Detailed Description This is a Phase I, open-label, multiple-ascending dose trial. Study consists of dose-escalation part in subjects with metastatic or locally advanced solid tumors, and expansion part with selected indications.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE Drug: SHR-1701
Subjects will receive an intravenous infusion of SHR-1701 in a pre-set dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Study Arms  ICMJE Experimental: SHR-1701
intravenous infusion
Intervention: Drug: SHR-1701
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: December 12, 2018)		 238
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2022
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able and willing to provide signed informed consent form, and able to comply with all procedures.
  • Histologically or cytologically proven metastatic or locally advanced solid tumors.
  • Male or female subjects aged 18-75 years.
  • Life expectancy >= 12 weeks as judged by the Investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.
  • Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Adequate hematological, hepatic and renal function as defined in the protocol

Other protocol-defined inclusion criteria could apply.

Exclusion Criteria:

  • Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor.
  • Anticancer treatment within 28 days before the first dose of study drug.
  • Major surgery within 28 days before start of trial treatment.
  • Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.
  • With any active autoimmune disease or history of autoimmune disease.
  • With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention.
  • Clinically significant cardiovascular and cerebrovascular diseases
  • History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy.
  • Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded.
  • Receipt of any organ transplantation, including allogeneic stem-cell transplantation

Other protocol-defined exclusion criteria could apply
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: Linna Wang, MD +86-21-68868570 wanglinna@hrglobe.cn
Contact: Ye Xia, MD xiaye@hrglobe.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03774979
Other Study ID Numbers  ICMJE SHR-1701-I-102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jifeng Feng, MD Jiangsu Cancer Institute & Hospital
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date April 2020

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