A Study of RO6958688 in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen Positive Solid Tumors
Status:
Completed
Trial end date:
2019-09-03
Target enrollment:
Participant gender:
Summary
Study BP29541 is a first-in-human, open-label, multi-center, dose-escalation Phase I clinical
study of single-agent RO6958688 in participants with locally advanced and/or metastatic
carcinoembryonic antigen (CEA) positive solid tumors who have progressed on standard
treatment, are intolerant to standard of care (SOC), and/or are non-amenable to SOC. The
study will be conducted in two parts. Part I of the study will investigate the safety and
pharmacokinetics of a single dose of RO6958688 in single participant cohorts with dosing
starting from a minimal anticipated biological effect level dose of 0.05 milligrams (mg) and
up to a maximum dose of 2.5 mg. Part II will establish the appropriate therapeutic dose based
on safety, pharmacokinetics, and the maximum tolerated dose (MTD) of RO6958688 for the once
per week (QW) regimen, every three weeks (Q3W) regimen, and for the step up dosing regimen.