Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of SHR-A1811, in Patients With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: a Phase 1 Study

SHR-A1811-I-102

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.

2021-03-30

2024-06-01

2024-12-01

Active (not recruiting)

Early phase I

101

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.

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2024-03-20