Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab.
The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Documented advanced or metastatic cancer ineligible for standard therapies with one of the following histologies
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Evaluable disease at baseline (at least one measurable target lesion by imaging for expansion cohorts)
Tumor available for biopsy
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
323 participants in 4 patient groups
Loading...
Central trial contact
Clinical Trial Manager
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal