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NCT04513223 Clinical Trial

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

Colorectal Cancer Clinical Trial

Official title:
Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of SHR-A1811, in Patients With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: a Phase 1 Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04513223
Other study ID # SHR-A1811-I-102
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date March 30, 2021
Est. completion date December 2024

Study information
Verified date March 2024
Source Jiangsu HengRui Medicine Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 101
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Has a pathologically or cytologically documented advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma and colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. - 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 unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade = 1. - Has received HER2 antibody drug conjugates,. - Central nervous system metastasis or meningeal metastasis with clinical symptoms - Has active infection requiring systemic treatment.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SHR-A1811
There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose

Locations
Country Name City State
China Shanghai East Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary DLT and the recommended Phase 2 dose (RP2D) Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-21).
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