Trials / Completed
CompletedNCT04513223
A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 101 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-A1811 | There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose |
Timeline
- Start date
- 2021-03-30
- Primary completion
- 2025-03-28
- Completion
- 2025-03-28
- First posted
- 2020-08-14
- Last updated
- 2026-02-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04513223. Inclusion in this directory is not an endorsement.