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

Jiangsu HengRui Medicine Co., Ltd.396 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

396

Conditions

Advanced Solid Tumors

Interventions

SHR-A1811DRUG

be administered via intravenous (IV) infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (35)

Outcomes

Primary Outcomes

Incidence and severity of adverse events (AEs)

Frequency and seriousness of treatment emergent adverse events (TEAEs)

Time frame: From Day1 to 90 days after last dose

Secondary Outcomes

PK parameter: Tmax of SHR-A1811

Time to maximal concentration (Tmax) of SHR-A1811

Time frame: Through study completion, an average of 1 year

PK parameter: Cmax of SHR-A1811

Maximal concentration (Cmax) of SHR-A1811

Time frame: Through study completion, an average of 1 year

PK parameter: AUC0-t of SHR-A1811

AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811

Time frame: Through study completion, an average of 1 year

Immunogenicity of SHR-A1811

Including anti-drug antibody and/or neutralizing antibody

Time frame: Through study completion, an average of 1 year

Tumor response using RECIST 1.1

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

Time frame: From first dose to disease progression or death, whichever comes first, up to 30 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Montefiore-Einstein Center for Cancer Care

The Bronx, New York, United States

Greenville Hospital System

Greenville, South Carolina, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

Macquarie University Hospital

Macquarie, New South Wales, Australia

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, Australia

Peninsula and South Eastern Haematology & Oncology Group

Frankston, Victoria, Australia

Nucleus Network

Melbourne, Victoria, Australia

Alfred Hospital

Melbourne, Australia

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

...and 25 more locations