Trials / Terminated
TerminatedNCT04735575
A Ph1/2 Study of EMB-06 in Participants With Relapsed or Refractory Myeloma
A First-in-human, Phase I/II, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of EMB-06 in Patients With Relapsed or Refractory Multiple Myeloma
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (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-06 and to characterize the safety and tolerability of EMB-06 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-06 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 dose (RP2D) for EMB-06 in patients with relapsed or refractory multiple myeloma. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | EMB-06 | EMB-06 is a FIT-Ig® bispecific antibody against BCMA and CD3. |
Timeline
- Start date
- 2021-05-20
- Primary completion
- 2024-08-20
- Completion
- 2024-08-20
- First posted
- 2021-02-03
- Last updated
- 2025-05-28
Locations
10 sites across 2 countries: Australia, China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04735575. Inclusion in this directory is not an endorsement.