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Protocol NumberSHR-A1811-I-101
NCT Number(ClinicalTrials.gov Identfier)NCT04446260

2020-10-01 - 2023-09-30

Phase I

Recruiting3

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Jiangsu HengRui Medicine Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Yung-Chang Lin Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

HER2 expressing or mutated Advanced Solid Tumors

Objectives

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.

Test Drug

Drug: SHR-A1811

Active Ingredient

SHR-A1811

Dosage Form

lyophilized powder for injection

Dosage

100 mg/vial

Endpoints

Primary Outcome Measures:
Incidence and severity of adverse events (AEs)

Secondary Outcome Measures:
1.PK parameter: Tmax of SHR-A1811
2.PK parameter: Cmax of SHR-A1811
3.PK parameter: AUC0-t of SHR-A1811
4.Immunogenicity of SHR-A1811
5.Tumor response using RECIST 1.1

Inclution Criteria

1.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
2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3.LVEF ≥ 50% by either ECHO or MUGA
4.Has adequate renal and hepatic function
5.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

1.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
2.Known hereditary or acquired bleeding and thrombotic tendency

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    226 participants

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