Trials / Completed
CompletedNCT04446260
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 396 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-A1811 | be administered via intravenous (IV) infusion |
Timeline
- Start date
- 2020-09-07
- Primary completion
- 2025-06-04
- Completion
- 2025-06-04
- First posted
- 2020-06-24
- Last updated
- 2025-09-15
Locations
35 sites across 5 countries: United States, Australia, China, South Korea, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04446260. Inclusion in this directory is not an endorsement.