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Completed

NCT Number: NCT04446260

A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Macquarie University Hospital, Macquarie, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHR-A1811

Drug

be administered via intravenous (IV) infusion

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Collaborators

  • Atridia Pty Ltd.

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2020
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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