A Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
This is an open-label Phase 1 dose escalation study of OMP-59R5 in subjects with previously
treated solid tumors for which there is no remaining standard curative therapy and no therapy
with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers.
Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and
efficacy. No formal interim analyses will be performed.
Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon
enrollment, subjects will receive intravenous (IV) infusions of OMP-59R5 at a assigned dosing
schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there
is no evidence of disease progression or if the tumor is smaller, then subjects may continue
to receive IV infusions of OMP-59R5 every week until disease progression.
Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose
escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled
in a cohort will not be treated on the same day. The dose may be administered at any time
during the day. Three subjects will be treated at each dose level if no dose-limiting
toxicities (DLTs) are observed. The first 2 subjects in each cohort will not be started on
OMP-59R5 on the same day. If 1 of 3 subjects experiences a DLT, that dose level will be
expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be
dosed at that level and 3 additional subjects will be added to the preceding dose cohort
unless 6 subjects have already been treated at that dose level. Subjects will be assessed for
DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled
subjects, if appropriate, will occur after all subjects in a cohort have completed their Day
28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to
continue to receive weekly doses of OMP-59R5 until disease progression. An additional 14
subjects will be enrolled at the highest dose level that result in <2 of the 6 subjects
experiencing a DLT.