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A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors

NCT04513223 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2026-02-06

No results posted yet for this study

Summary

This is a single arm, open-label, dose escalation, PK expansion and efficacy expansion study of phase I. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.

Conditions

Interventions

DRUG

SHR-A1811

There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-30
Primary Completion
2025-03-28
Completion
2025-03-28

Countries

  • China

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 NCT04513223 on ClinicalTrials.gov