Trials / Completed
CompletedNCT03828292
An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments
A Phase I Open-Label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of the Antibody Drug Conjugate GSK2857916 in Japanese Participants With Relapsed/Refractory Multiple Myeloma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
Belantamab mafodotin (GSK2857916) is a first in class, antibody dependent cellular cytotoxicity (ADCC) enhanced, humanized immunoglobulin G1 (IgG1) antibody-drug conjugate (ADC) which binds specifically to B cell maturation antigen (BCMA) expressed on tumor cells of all participants with multiple myeloma. This is a Phase 1, open label, dose escalation study to investigate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and clinical activity of GSK2857916 when given as monotherapy (Part 1) or given as combination therapy (Part 2). Dose escalation will follow a 3+3 design.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Belantamab mafodotin | Belantamab mafodotin will be administered as an intravenous infusion. |
| DRUG | Bortezomib | Bortezomib solution for injection will be administered subcutaneously. |
| DRUG | Dexamethasone | Dexamethasone tablets will be administered orally. |
| DRUG | Pomalidomide | Pomalidomide capsules will be administered orally. |
Timeline
- Start date
- 2019-03-14
- Primary completion
- 2023-04-06
- Completion
- 2024-09-05
- First posted
- 2019-02-04
- Last updated
- 2025-08-19
- Results posted
- 2025-04-10
Locations
4 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03828292. Inclusion in this directory is not an endorsement.