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NCT04446351 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Neoplasms, sponsored by GlaxoSmithKline.

Active
Registry status
Phase 1
Development phase
107
Enrollment target
11
Study locations

NCT04446351 is a Phase 1 study of Neoplasms that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 107 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (93% lower). The trial reports 11 study locations across 5 states.

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The verdict

NCT04446351, a Phase 1 study of Neoplasms, is active but no longer recruiting, sponsored by GlaxoSmithKline.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
107 participants
Enrollment target
11
Study locations

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 Studied

Neoplasms

Interventions

  • DRUG Dostarlimab
  • DRUG Belrestotug
  • DRUG Cobolimab
  • DRUG GSK6097608

Study Locations (11)

Other

  • GSK Investigational Site - Chiba
  • GSK Investigational Site - Tokyo
  • GSK Investigational Site - Seoul
  • GSK Investigational Site - Seoul

Texas

  • GSK Investigational Site - Dallas
  • GSK Investigational Site - Houston
  • GSK Investigational Site - San Antonio

Ontario

  • GSK Investigational Site - Ottawa
  • GSK Investigational Site - Toronto

California

  • GSK Investigational Site - Los Angeles

Massachusetts

  • GSK Investigational Site - Boston

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2020-06-25
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT04446351

The ClinicalTrials.gov registry entry for NCT04446351 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (93% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Dostarlimab is the first listed.

NCT04446351 reports 11 study locations spanning 5 distinct geographic areas - top geographies include Other, Texas, Ontario.

Frequently Asked Questions

What is clinical trial NCT04446351 about?

NCT04446351 is a clinical study titled "Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors". 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 addi...

What is the current status of trial NCT04446351?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2020-06-25. Estimated completion is 2026-12-31.

What conditions does trial NCT04446351 study?

This clinical trial studies the following conditions: Neoplasms.

What interventions are being tested in trial NCT04446351?

The interventions under investigation include: Dostarlimab (DRUG), Belrestotug (DRUG), Cobolimab (DRUG), GSK6097608 (DRUG).

Who is sponsoring clinical trial NCT04446351?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04446351 being conducted?

This trial has 11 study locations across California, Massachusetts, Texas, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.