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

NCT04446260 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2025-09-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SHR-A1811

be administered via intravenous (IV) infusion

Sponsors & Collaborators

  • Atridia Pty Ltd.

    collaborator INDUSTRY

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-07
Primary Completion
2025-06-04
Completion
2025-06-04
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04446260 on ClinicalTrials.gov