Trials / Unknown
UnknownNCT05263180
A Study of EMB-09 in Participants With Advanced or Metastatic Solid Tumors.
A First-in-human, Phase I Trial of EMB-09, a Bispecific Antibody Targeting PD-L1 and OX-40 in Patients With Advanced or Metastatic Solid Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is to evaluate the safety and tolerability of EMB-09 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-09 will also be assessed.
Detailed description
This is a phase I, 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 dose for EMB-09 in patient with advanced or metastatic solid tumors. Pharmacokinetics,pharmacodynamics, immunogenicity and response will also be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | EMB-09 | EMB-09 is a FIT-Ig® bispecific antibody against PD-L1 and OX40. |
Timeline
- Start date
- 2022-07-25
- Primary completion
- 2023-12-31
- Completion
- 2024-12-31
- First posted
- 2022-03-02
- Last updated
- 2023-10-18
Locations
4 sites across 2 countries: Australia, China
Source: ClinicalTrials.gov record NCT05263180. Inclusion in this directory is not an endorsement.