A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer

Last updated: June 11, 2024
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

N/A

Treatment

SHR-A1811

Clinical Study ID

NCT04818333
SHR-A1811-I-103
  • Ages 18-75
  • All Genders

Study Summary

This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression , amplification, or mutation

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able and willing to provide a written informed consent

  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  3. advanced non-small cell lung cancer with HER2 expression , amplification, ormutation

  4. has previously received platinum-based chemotherapy for advanced or metastaticNSCLC, has developed disease progression during or after treatment, or is unable totolerate platinum-based chemotherapy.

  5. There is at least one measurable lesion according to RECIST V1.1 criteria

Exclusion

Exclusion Criteria:

  1. Has unresolved toxicities from previous anticancer therapy, defined as toxicitiesnot yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.

  2. Has received HER2 antibody drug conjugates,

  3. Central nervous system metastasis or meningeal metastasis with clinical symptoms

  4. Has active infection requiring systemic treatment.

Study Design

Total Participants: 157
Treatment Group(s): 1
Primary Treatment: SHR-A1811
Phase: 1/2
Study Start date:
April 23, 2021
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Shanghai Chest Hospital

    Shanghai, Shanghai 200030
    China

    Site Not Available

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