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NCT03843359 · ClinicalTrials.gov registry record · Phase 1
A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors
A Phase 1 study of Neoplasms, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 1
- Development phase
- 97
- Enrollment target
- 13
- Study locations
NCT03843359: Active Phase 1 study of Neoplasms, sponsored by GlaxoSmithKline.
NCT03843359 is a Phase 1 study of Neoplasms that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 97 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (94% lower). The trial reports 13 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03843359, a Phase 1 study of Neoplasms, is active but no longer recruiting, sponsored by GlaxoSmithKline.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 97 participants
- Enrollment target
- 13
- Study locations
Study Summary
This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone (Part 1A) or co-administered (Part 2A) with dostarlimab in participants with refractory/relapsed solid tumors. Both parts will consist of a dose escalation phase.
Primary Outcome
AE is DLT if deemed clinically relevant,attributed to study intervention \& met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite thera
Conditions Studied
Interventions
- DRUG Dostarlimab
- DRUG GSK3745417
Study Locations (13)
Other
- GSK Investigational Site - Bordeaux
- GSK Investigational Site - Villejuif
- GSK Investigational Site - Tokyo
- GSK Investigational Site - Tokyo
- GSK Investigational Site - Amsterdam
- GSK Investigational Site - Amsterdam
- GSK Investigational Site - Seoul
- GSK Investigational Site - Barcelona
- GSK Investigational Site - Madrid
- GSK Investigational Site - Madrid
Texas
- GSK Investigational Site - Houston
Victoria
- GSK Investigational Site - Melbourne
Ontario
- GSK Investigational Site - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2019-03-12 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
What the registry record for NCT03843359 still lists
NCT03843359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Dostarlimab is the first listed.
NCT03843359 lists 13 locations in 4 states (Other, Texas, Victoria).
Frequently Asked Questions
What is clinical trial NCT03843359 about?
NCT03843359 is a clinical study titled "A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors". This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone (Part 1A) or co-administered (Part 2A) with dostarlimab in participants with refractory/relapsed solid tumors. Both parts will consist of a dose e...
What is the current status of trial NCT03843359?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2019-03-12. Estimated completion is 2026-03-31.
What conditions does trial NCT03843359 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT03843359?
The interventions under investigation include: Dostarlimab (DRUG), GSK3745417 (DRUG).
Who is sponsoring clinical trial NCT03843359?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03843359 being conducted?
This trial has 13 study locations across Texas, Victoria, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03843359's enrollment target sits among peer trials
97 73rd of 158 higher than 86 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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