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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: SHR-A1811 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 226 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 3, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1 Dose escalation Drug: SHR-A1811
be administered via intravenous (IV) infusion
Experimental: Part 2 Indication expansion Drug: SHR-A1811
be administered via intravenous (IV) infusion


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. PK parameter: Tmax of SHR-A1811 [ Time Frame: Through study completion, an average of 1 year ]
    Time to maximal concentration (Tmax) of SHR-A1811

  2. PK parameter: Cmax of SHR-A1811 [ Time Frame: Through study completion, an average of 1 year ]
    Maximal concentration (Cmax) of SHR-A1811

  3. 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

  4. Immunogenicity of SHR-A1811 [ Time Frame: Through study completion, an average of 1 year ]
    Including anti-drug antibody and/or neutralizing antibody

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT04446260


Contacts
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Contact: Sherry Zhu, MD, PhD +86 021-61053363 zhuxiaoyu@hrglobe.cn
Contact: Catherine Rong +86 021-61053363 rongshangyi@hrglobe.cn

Locations
Show Show 34 study locations
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Atridia Pty Ltd.
More Information
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04446260    
Other Study ID Numbers: SHR-A1811-I-101
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: December 27, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms