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

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Advanced Non-small Cell Lung Cancer

Treatments: Drug: SHR-A1811

Study type: Interventional

Funder types: Industry

Identifiers

NCT04818333

SHR-A1811-I-103

Details and patient eligibility

About

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

Enrollment: 157 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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157 participants in 1 patient group

SHR-A1811

Experimental group

Description:

SHR-A1811 was administered intravenously every 3 weeks (Q3W) until discontinuation treatment

Treatment:

Drug: SHR-A1811