A Study of RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors
Status:
Terminated
Trial end date:
2019-07-22
Target enrollment:
Participant gender:
Summary
This study was to determine the maximum-tolerated dose (MTD) and/or the optimal biological
dose (OBD) as well as the optimal schedule for intravenous (IV) and subcutaneous (SC)
administrations of RO7172508 as monotherapy, with or without obinutuzumab pre-treatment, in
participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA)-positive
solid tumors who have progressed on standard of care (SOC) treatment, are intolerant to SOC,
and/or are non-amenable to SOC. This study was conducted in two parts. Part I of the study
consisted of an IV single participant cohort/multiple-ascending dose-escalation to evaluate
the safety of RO7172508. Part II was a multiple participant cohort/multiple-ascending
dose-escalation to define the MTD and/or OBD of RO7172508 administered as single agent, IV
and/or SC, in participants with tumors that are expressing high as well as moderate/low-CEA.
The study switched from Part I to Part II when the maximum planned dose for Part I was
reached or the occurrence of a RO7172508-related Grade >= 2 adverse event (AE) or
dose-limiting toxicity (DLT) was observed, whichever comes first. The Sponsor may decide to
switch from Part I to Part II in the absence of an observed RO7172508-related Grade >= 2
toxicity or prior to maximum planned dose for Part I.