Trials / Unknown
UnknownNCT05188209
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer.
A Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in EGFR-Positive, HER2-Negative Advanced Gastric Cancer.
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Shanghai Miracogen Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with EGFR-positive, HER2-negative, inoperable locally advanced or metastatic gastric cancer.
Detailed description
Approximately 6054 patients will be enrolled to evaluate the safety and preliminarily efficacy of MRG003. Patients will receive 2.0 mg/kg dose of MRG003 intravenously every 3 weeks (Q3W) and may receive up to 24 months of MRG003 if there is evidence of clinical benefit to the patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MRG003 | Administered intravenously |
Timeline
- Start date
- 2021-05-24
- Primary completion
- 2023-03-21
- Completion
- 2023-08-01
- First posted
- 2022-01-12
- Last updated
- 2022-01-12
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05188209. Inclusion in this directory is not an endorsement.