A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors
Phase 1
Terminated
NCT03843359
| Condition | Neoplasms |
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| Phase | Phase 1 |
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| Sponsor | GlaxoSmithKline |
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| Status | Terminated |
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| Enrollment | 97 participants |
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| Interventions | GSK3745417, Dostarlimab |
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| Start date | Mar 12, 2019 |
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| Completion date | Apr 4, 2024 |
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| Results posted | Jan 8, 2026 |
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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.
Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W)
Up to 21 Days · Participants
| Part 1A: GSK3745417 0.1 mg (Q1W) | 0 Participants |
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| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | 0 Participants |
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| Part 1A: GSK3745417 0.2 mg (Q1W) | 0 Participants |
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| Part 1A: GSK3745417 0.4 mg (Q1W) | 2 Participants |
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Parts 1A: Number of Participants Achieving DLT Following Administration of GSK3745417 Alone (Q3W)
Up to 29 Days · Participants
| Part 1A: GSK3745417 0.1 mg (Q3W) | 0 Participants |
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| Part 1A: GSK3745417 0.2 mg (Q3W) | 0 Participants |
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Parts 2A: Number of Participants Achieving DLT Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
Up to 29 Days · Participants
| Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab | 0 Participants |
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| Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab | 0 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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