Last updated on June 2019

Phase 1 First Time in Humans (FTIH) Open Label Study of GSK3745417 Administered to Subjects With Advanced Solid Tumors

Brief description of study

This is a Phase I, FTIH, open-label, repeat-dose, non-randomized, multicenter, multi-country study to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered intravenously (IV) alone (Part 1) or co-administered (Part 2) with pembrolizumab in subjects with refractory/relapsed solid tumors. Each part consists of a dose escalation phase and a cohort expansion phase. In Part 1A, escalating doses of GSK3745417 will be evaluated as guided by the Neuenschwander-continuous reassessment method (N-CRM) approach. In Part 2A, escalating doses of GSK3745417 in combination with 200 milligrams (mg) pembrolizumab will be evaluated as guided by the N-CRM approach. In Part 1B and 2B, subjects will receive a single dose level of GSK3745417 as identified based on data from Part 1, either alone or in combination with pembrolizumab. A total of approximately 300 subjects will be enrolled in this study, approximately 120 for dose escalation cohorts, and approximately 180 in the expansion cohorts.

Clinical Study Identifier: NCT03843359

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Recruitment Status: Open

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