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

NCT04446351 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2025-10-27

No results posted yet for this study

Summary

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.

Conditions

  • Neoplasms

Interventions

DRUG

GSK6097608

GSK6097608 will be administered as an IV infusion.

DRUG

Dostarlimab

Dostarlimab will be administered as an IV infusion.

DRUG

Cobolimab

Cobolimab will be administered as an IV infusion.

DRUG

Belrestotug

Belrestotug will be administered as an IV infusion.

Sponsors & Collaborators

  • 23andMe, Inc.

    collaborator INDUSTRY

  • iTeos Therapeutics

    collaborator INDUSTRY

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Japan
  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04446351 on ClinicalTrials.gov