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

Find a site near you

Start Over

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.