Trials / Terminated
TerminatedNCT03571828
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With r/r Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma
A Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With Relapsed / Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the safety and tolerability of AMG 562 in adult subjects with DLBCL, MCL, or FL. Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (e.g., recommended phase 2 dose \[RP2D\])
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 562 | AMG 562 is a BiTE® antibody construct that targets CD19 and is intended for the treatment of patients with B-cell malignancies. |
Timeline
- Start date
- 2018-10-29
- Primary completion
- 2022-01-12
- Completion
- 2022-01-12
- First posted
- 2018-06-28
- Last updated
- 2024-03-22
- Results posted
- 2024-03-22
Locations
12 sites across 4 countries: United States, Belgium, Canada, Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03571828. Inclusion in this directory is not an endorsement.