Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
GlaxoSmithKline
Study ID
NCT04446351
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

  • GSK6097608 — DRUG
    GSK6097608 will be administered as an IV infusion.
  • Dostarlimab — DRUG
    Dostarlimab will be administered as an IV infusion.
  • Cobolimab — DRUG
    Cobolimab will be administered as an IV infusion.
  • Belrestotug — DRUG
    Belrestotug will be administered as an IV infusion.

Study Details

This first-time-in-human (FTIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants with advanced solid tumors. In addition, dostarlimab will be given as monotherapy (Arm D); and in combination with belrestotug (Arm E); and with GSK6097608 + belrestotug (Arm F) in Japanese and Chinese participants. The study may assess the PK/PD cohorts for Arm E and/or Arm F in participants outside of China and Japan. Additionally, dostarlimab will be given in combination with cobolimab in Japanese participants. Drug name mentioned as belrestotug, GSK4428859A and EOS884448 are interchangeable for the same compound. In the rest of the document, the drug will be referred to as belrestotug.

Key Dates

Start date
Jun 25, 2020
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Participants receiving GSK6097608 monotherapy (Arm A)
    Participants will be administered an intravenous (IV) infusion of GSK6097608 every 3 weeks as monotherapy in escalating doses.
  • Experimental: Participants receiving GSK6097608 plus dostarlimab (Arm B)
    Participants will be administered IV infusion of GSK6097608 every 3 weeks in escalating doses followed by dostarlimab.
  • Experimental: Participants receiving dostarlimab monotherapy (Arm D)
    Participants will be administered an IV infusion of dostarlimab monotherapy (1 cohort will receive dostarlimab every 3 weeks and 1 cohort will receive dostarlimab every 6 weeks).
  • Experimental: Participants receiving dostarlimab plus belrestotug (Arm E)
    Participants will be administered IV infusions of dostarlimab followed by belrestotug, every 3 weeks.
  • Experimental: Participants receiving dostarlimab plus belrestotug plus GSK6097608 (Arm F)
    Participants will be administered an IV infusion of dostarlimab followed by belrestotug followed by GSK6097608 every 3 weeks.
  • Experimental: Participants receiving dostarlimab plus cobolimab (Arm G)
    Participants will be administered an IV infusion of cobolimab followed by dostarlimab

Primary Outcome Measure

Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Up to Day 21 ]

Locations (5)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteLos AngelesCalifornia90025-
GSK Investigational SiteBostonMassachusetts02215-
GSK Investigational SiteDallasTexas75230-
GSK Investigational SiteHoustonTexas77030-4009-
GSK Investigational SiteSan AntonioTexas78229-

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