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

Jiangsu HengRui Medicine Co., Ltd.35 sites in 5 countries396 target enrollmentSeptember 7, 2020

InterventionsSHR-A1811

DrugsSHR-A1811

Overview

Phase: Phase 1
Intervention: SHR-A1811
Conditions: Not specified
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 396
Locations: 35
Primary Endpoint: Incidence and severity of adverse events (AEs)
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 7, 2020

End Date

June 4, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Part 1 Dose escalation

Intervention: SHR-A1811

Part 2 PK expansion

Intervention: SHR-A1811

Part 3 Indication expansion

Intervention: SHR-A1811

Outcomes

Primary Outcomes

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

PK parameter: Tmax of SHR-A1811(Through study completion, an average of 1 year)
PK parameter: Cmax of SHR-A1811(Through study completion, an average of 1 year)
PK parameter: AUC0-t of SHR-A1811(Through study completion, an average of 1 year)
Immunogenicity of SHR-A1811(Through study completion, an average of 1 year)
Tumor response using RECIST 1.1(From first dose to disease progression or death, whichever comes first, up to 30 months)