Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat in Participants With RRMM

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
GlaxoSmithKline
Study ID
NCT07084896
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belantamab mafodotin — DRUG
    Belantamab mafodotin will be administered.
  • Nirogacestat — DRUG
    Nirogacestat will be administered.

Study Details

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).

Key Dates

Start date
Jun 8, 2020
Status verified
Apr 2026
Primary completion
Apr 17, 2025
Completion
Mar 11, 2027

Study Design

Enrollment
106 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Belantamab mafodotin + Nirogacestat

Primary Outcome Measure

DE Phase: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
238995AtlantaGeorgia30322-
240593BostonMassachusetts02215-
251164Grand RapidsMichigan49546-
239015MadisonWisconsin53792-

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