A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors
NCT ID: NCT04513223
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
101 participants
INTERVENTIONAL
2021-03-30
2025-03-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
NCT05814354
Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
NCT06413745
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
NCT04446260
SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response
NCT07129187
A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
NCT06778031
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SHR-A1811
SHR-A1811
There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SHR-A1811
There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1.
* Has an ECOG PS 0-1.
* Has a life expectancy of ≥ 3 months.
* Has adequate organ function
Exclusion Criteria
* Has received HER2 antibody drug conjugates,.
* Central nervous system metastasis or meningeal metastasis with clinical symptoms
* Has active infection requiring systemic treatment.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHR-A1811-I-102
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.