NCT04513223CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 101 (actual)
- First submitted
- 12 Aug 2020
- Start date
- 30 Mar 2021
- Primary completion date
- 28 Mar 2025
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- NCT number
- NCT04513223
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 101
- From 30 Mar 2021 to the primary completion date, 28 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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,.
Other illness
- Has active infection requiring systemic treatment.
Other
- Central nervous system metastasis or meningeal metastasis with clinical symptoms
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.