Trials / Active Not Recruiting
Active Not RecruitingNCT07084896
Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat in Participants With RRMM
A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5 - Sub-study 3 - Belantamab Mafodotin and Nirogacestat in Combination
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with nirogacestat and to establish the recommended Phase 2 dose for combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study is a sub study of the Master protocol (NCT04126200).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Belantamab mafodotin | Belantamab mafodotin will be administered. |
| DRUG | Nirogacestat | Nirogacestat will be administered. |
Timeline
- Start date
- 2020-06-08
- Primary completion
- 2025-04-17
- Completion
- 2027-03-11
- First posted
- 2025-07-25
- Last updated
- 2025-07-25
Locations
29 sites across 13 countries: United States, Australia, Canada, France, Germany, Greece, Netherlands, Norway, Poland, Russia, South Korea, Spain, Sweden
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07084896. Inclusion in this directory is not an endorsement.