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

• Status: Recruiting
• Trial end date: 2024-01-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

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, or mutation

4. has previously received platinum-based chemotherapy for advanced or metastatic NSCLC, has developed disease progression during or after treatment, or is unable to tolerate platinum-based chemotherapy.

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

Exclusion Criteria:

1. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not 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.