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A Study of SHR-A1811 in Subjects With Advanced Malignant 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: NCT04446260
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : December 27, 2021
Sponsor:
Collaborator:
Atridia Pty Ltd.
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 18, 2020
First Posted Date  ICMJE June 24, 2020
Last Update Posted Date December 27, 2021
Actual Study Start Date  ICMJE September 3, 2020
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2020)		 Incidence and severity of adverse events (AEs) [ Time Frame: From Day1 to 90 days after last dose ]
Frequency and seriousness of treatment emergent adverse events (TEAEs)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2020)
  • PK parameter: Tmax of SHR-A1811 [ Time Frame: Through study completion, an average of 1 year ]
    Time to maximal concentration (Tmax) of SHR-A1811
  • PK parameter: Cmax of SHR-A1811 [ Time Frame: Through study completion, an average of 1 year ]
    Maximal concentration (Cmax) of SHR-A1811
  • PK parameter: AUC0-t of SHR-A1811 [ Time Frame: Through study completion, an average of 1 year ]
    AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811
  • Immunogenicity of SHR-A1811 [ Time Frame: Through study completion, an average of 1 year ]
    Including anti-drug antibody and/or neutralizing antibody
  • Tumor response using RECIST 1.1 [ Time Frame: From first dose to disease progression or death, whichever comes first, up to 30 months ]
    RECIST=Response Evaluation Criteria in Solid Tumors Assessment of tumor response until disease progression or death to evaluate the efficacy of SHR-A1811 up to 30 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
Official Title  ICMJE A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects
Brief Summary This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE Drug: SHR-A1811
be administered via intravenous (IV) infusion
Study Arms  ICMJE
  • Experimental: Part 1 Dose escalation
    Intervention: Drug: SHR-A1811
  • Experimental: Part 2 Indication expansion
    Intervention: Drug: SHR-A1811
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: June 22, 2020)		 226
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • LVEF ≥ 50% by either ECHO or MUGA
  • Has adequate renal and hepatic function
  • Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment

Exclusion Criteria:

  • History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period
  • Known hereditary or acquired bleeding and thrombotic tendency
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sherry Zhu, MD, PhD +86 021-61053363 zhuxiaoyu@hrglobe.cn
Contact: Catherine Rong +86 021-61053363 rongshangyi@hrglobe.cn
Listed Location Countries  ICMJE Australia,   China,   Korea, Republic of,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04446260
Other Study ID Numbers  ICMJE SHR-A1811-I-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Atridia Pty Ltd.
Investigators  ICMJE Not Provided
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date December 2021

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