Trials / Completed
CompletedNCT03489525
MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma
A Phase 1, Open-label Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 18 Years – 101 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety, pharmacokinetics and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD \[in the absence of establishing the MTD\]) for single agent MEDI2228 in adult subjects with multiple myeloma who are either transplant ineligible or post autologous stem cell transplant and are relapsed/refractory.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Dose Escalation, MEDI2228, ADC (antibody drug conjugate) | Single agent MEDI2228 will be administered to adult subjects with R/R MM. The study aims to evaluate up to 9 planned, sequentially ascending main dose levels |
| BIOLOGICAL | Dose Expansion, MEDI2228, ADC (antibody drug conjugate) | Adult subjects with R/R MM with measurable disease will be enrolled in the dose-expansion cohort at the dose selected for evaluation in the dose-expansion phase. |
Timeline
- Start date
- 2018-05-08
- Primary completion
- 2022-03-21
- Completion
- 2022-03-21
- First posted
- 2018-04-05
- Last updated
- 2022-03-28
Locations
11 sites across 4 countries: United States, Australia, Greece, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03489525. Inclusion in this directory is not an endorsement.