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

Hengrui Medicine

Status and phase

Completed

Phase 1

Conditions

Gastric Cancer

Colorectal Cancer

Treatments

Drug: SHR-A1811

Study type

Interventional

Funder types

Industry

Identifiers

NCT04513223

SHR-A1811-I-102

Details and patient eligibility

About

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.

Enrollment

101 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Has a pathologically or cytologically documented advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma and colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
At least one evaluable or measurable lesion should be present and identified according to 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 criteria

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