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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: Active Phase 1 study of Neoplasms, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2020-06-25 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04446351 still lists
NCT04446351 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (93% lower).
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 lists 11 locations in 5 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04446351's enrollment target sits among peer trials
107 68th of 158 higher than 91 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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