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

Last updated: March 19, 2024
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Colorectal Cancer

Rectal Cancer

Colon Cancer; Rectal Cancer

Treatment

SHR-A1811

Clinical Study ID

NCT04513223
SHR-A1811-I-102
  • Ages 18-75
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a pathologically or cytologically documented advanced/unresectable or metastaticgastric or gastroesophageal junction adenocarcinoma and colorectal cancer that isrefractory to or intolerable with standard treatment, or for which no standardtreatment is available.
  • At least one evaluable or measurable lesion should be present and identified accordingto 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

Exclusion Criteria:

  • Has unresolved toxicities from previous anticancer therapy, defined as toxicities notyet 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

Total Participants: 101
Treatment Group(s): 1
Primary Treatment: SHR-A1811
Phase: 1
Study Start date:
March 30, 2021
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Shanghai East Hospital

    Shanghai, Shanghai Shanghai
    China

    Site Not Available

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