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

Jiangsu HengRui Medicine Co., Ltd.101 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

101

Conditions

Gastric Cancer Colorectal Cancer

Interventions

SHR-A1811DRUG

There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

DLT and the recommended Phase 2 dose (RP2D)

Time frame: Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-21).

Data from ClinicalTrials.gov

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