A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors

Hengrui Medicine

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: SHR-A1811

Study type: Interventional

Funder types: Industry

Identifiers

NCT04446260

SHR-A1811-I-101

Details and patient eligibility

About

This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.

Enrollment: 226 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• LVEF ≥ 50% by either ECHO or MUGA
• Has adequate renal and hepatic function
• Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment

Exclusion criteria

• History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period
• Known hereditary or acquired bleeding and thrombotic tendency

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

Part 1 Dose escalation

Experimental group

Treatment:

Drug: SHR-A1811

Part 2 Indication expansion

Experimental group

Treatment:

Drug: SHR-A1811