Trials / Completed
CompletedNCT04868344
A Study of MRG003 in Patients With Advanced Solid Tumors
An Open-Label, Dose-Finding, Phase I Study in Solid Tumors.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Shanghai Miracogen Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the safety, efficacy, and pharmacokinetics of MRG003, as well as immunogenicity as defined by the incidence of anti-drug antibody (ADA) of MRG003 in patients with advanced solid tumors, including colorectal cancer, squamous cell carcinoma of head and neck, and nasopharyngeal carcinoma.
Detailed description
This study consists of two parts: Phase Ia dose escalation and Phase Ib dose expansion. The objective of Phase Ia is to determine MTD or RP2D, and Phase Ib is conducted to evaluate efficacy of MRG003 in patients with advanced colorectal cancer, squamous cell carcinoma of head and neck (SCCHN), and nasopharyngeal carcinoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MRG003 | Administered intravenously |
Timeline
- Start date
- 2018-05-09
- Primary completion
- 2021-03-29
- Completion
- 2021-03-29
- First posted
- 2021-04-30
- Last updated
- 2021-04-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04868344. Inclusion in this directory is not an endorsement.