Trials / Unknown
UnknownNCT04941339
A Study of MRG002 in the Treatment of Patients With HER2-positive Advanced Solid Tumors
A Phase I, Open-label, Multi-center, First in Human, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of MRG002 in Patients With HER2 Positive Advanced Solid Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 74 (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 MRG002 in patients with HER2-positive advanced solid tumors.
Detailed description
This study consists of two parts. Phase Ia is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG002. Phase Ib is a dose expansion study to further assess the efficacy and safety of MRG002 at confirmed RP2D.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MRG002 | Administrated intravenously |
Timeline
- Start date
- 2018-11-21
- Primary completion
- 2022-10-01
- Completion
- 2022-10-01
- First posted
- 2021-06-28
- Last updated
- 2021-12-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04941339. Inclusion in this directory is not an endorsement.