An Open-Label, Multicenter, Dose-Escalation Phase I Study to Evaluate the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688, a Novel T-cell Bispecific Antibody that Targets the Human Carcinoembryonic Antigen (CEA) on Tumor Cells and CD3 on T Cells, Administered Intravenously in Patients with Locally Advanced and/or Metastatic CEA(+) Solid Tumors (WIRB)

What is the purpose of this trial?

This study is a first-in-human, open-label, multi-center, dose-escalation Phase 1 clinical study of single-agent RO6958688 in patients with locally advanced and/or metastatic 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 1 will investigate the safety and pharmacokinetics of a single dose of RO6958688 in single patient cohorts. Part 2 will establish the appropriate therapeutic dose(s) based on safety, pharmacokinetics, and the maximum tolerated dose of RO6958688 for the weekly schedule. The anticipated time on treatment is a maximum of 24 months. The overall target sample size is 90.

Hoffman-La Roche

Dates: 03/17/2016 - 10/01/2018

Last Updated: 02/22/2018

Study HIC#: 1505015802

Get Involved

For more information about this study, contact:
Jacqueline Rollin
+1 203-859-0001

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email or call 1-877-978-8348.

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Joseph Paul Eder

Principal Investigator