First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors

Part of paid clinical trials in San Francisco, California.

Sponsor
GlaxoSmithKline
Study ID
NCT05277051
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

  • Remzistotug — DRUG
    Remzistotug will be administered.
  • Dostarlimab — DRUG
    Dostarlimab will be administered.
  • Belrestotug — DRUG
    Belrestotug will be administered.
  • Nelistotug — DRUG
    Nelistotug will be administered.
  • GSK5764227 — DRUG
    GSK5764227 will be administered.

Study Details

This is a first time in-human (FTIH) study designed to investigate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of remzistotug in participants with select loco-regionally recurrent solid tumors or metastatic solid tumors where curative or standard treatment options have been exhausted.

Key Dates

Start date
Mar 22, 2022
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
152 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants Receiving remzistotug Monotherapy (Arm A)
  • Experimental: Participants Receiving remzistotug Plus Dostarlimab (Arm B)
  • Experimental: Participants Receiving remzistotug Plus Dostarlimab Plus belrestotug (Arm C)
  • Experimental: Participants Receiving Dostarlimab Plus belrestotug (Arm D)
  • Experimental: Participants Receiving dostarlimab Plus belrestotug Plus remzistotug (Arm E)
  • Experimental: Participants Receiving dostarlimab Plus belrestotug Plus nelistotug (Arm F)
  • Experimental: China Cohort: Participants receiving dostarlimab (Arm G)
  • Experimental: Participants Receiving GSK5764227 Plus dostarlimab (Arm I)

Primary Outcome Measure

Arms A, B, C, I: Number of Participants with dose-limiting toxicities (DLTs) [ Time Frame: Up to 21 days ]

Locations (7)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteSan FranciscoCalifornia94158-
GSK Investigational SiteCharlotteNorth Carolina28204-
GSK Investigational SiteOklahoma CityOklahoma73104-
GSK Investigational SitePhiladelphiaPennsylvania19111-
GSK Investigational SiteDallasTexas75230-
GSK Investigational SiteSan AntonioTexas78229-
GSK Investigational SiteSalt Lake CityUtah84112-

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By research site
GSK Investigational Site· San Francisco, CAGSK Investigational Site· Charlotte, NCGSK Investigational Site· Oklahoma City, OKGSK Investigational Site· Philadelphia, PAGSK Investigational Site· Dallas, TXGSK Investigational Site· San Antonio, TX

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