Trials / Terminated
TerminatedNCT04618393
A Study of EMB-02 in Participants With Advanced Solid Tumors
A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients With Advanced Solid Tumors
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-02 and to characterize the safety and tolerability of EMB-02 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-tumor activity of EMB-02 will also be assessed.
Detailed description
This is a Phase I/II, multi-center, open label, multiple-dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dos(s)e (RP2D\[s\]) for EMB-02 in patients with advanced solid tumors. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | EMB-02 | EMB-02 is a FIT-Ig® bispecific antibody against PD-1 and LAG-3. |
Timeline
- Start date
- 2021-03-11
- Primary completion
- 2023-07-12
- Completion
- 2024-03-21
- First posted
- 2020-11-05
- Last updated
- 2024-05-21
Locations
10 sites across 3 countries: United States, Australia, China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04618393. Inclusion in this directory is not an endorsement.