At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 101 enrolled
Drug / intervention
SHR-A1811drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating SHR-A1811 for Gastric Cancer and Colorectal Cancer. Completed, enrolled 101 participants across 1 site.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer, Colorectal Cancer
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartMar 2021
Primary CompletionMar 2025
TodayJul 2026
First PostedAug 14, 2020
Enrollment StartMar 30, 2021
Primary CompletionMar 28, 2025
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 5.9 years ago
Interventions
SHR-A1811drug
There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose