Solid Tumors Clinical Trial
Official title:
A Phase 1 Dose Escalation Study of OMP-54F28 in Subjects With Solid Tumors
This is an open-label Phase 1 dose escalation study of OMP-54F28 in subjects with a solid
tumor for which there is no remaining standard curative therapy. 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 OMP-54F28 until disease progression. All subjects will
receive Vitamin D3 daily and calcium carbonate twice daily from Day 0 through 30 days
following the discontinuation of OMP-54F28.
Dose escalation will be conducted to determine the maximum tolerated dose (MTD). Subjects
will be dosed at 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks. No dose
escalation or reduction will be allowed within a dose cohort. Intermediate doses (i.e., doses
between the dose levels listed above) may also be tested upon agreement with the
investigators and the study sponsor. In addition, alternate dosing schedule cohorts of
OMP-54F28 (eg. every 4 week or every 6 week dosing) can be studied upon agreement with the
investigators and the study sponsor. These alternative less frequent dosing schedules may be
evaluated if emerging data suggest that once every 3 week dosing results in tolerability
concerns. 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. 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 Days 0-28. Dose escalation for newly enrolled
subjects, if appropriate, will occur after all subjects in a cohort have completed their Day
28 DLT assessment. Subjects who have a >2-fold increase of their fasting β-CTX or a decline
of >3% in their bone mineral density (BMD) from screening or a T-score decline to <-2.5 in
the total femur or L1-L4 DEXA scan measurement will be started on zoledronic acid. Subjects
with stable disease or a response at Day 56 will be allowed to continue to receive OMP-54F28
until disease progression. An additional 6 subjects will be enrolled in an expansion cohort
at the highest dose level that results in <2 of the 6 subjects experiencing a Grade 3 (not
including a Grade 3 infusion reaction that resolves in 24 hours) or Grade 4 adverse event
(DLT). Tumors of particular interest for inclusion in the expansion cohort include sarcomas,
basal cell carcinoma, ovarian cancer, desmoid tumors and prostate cancer given the known
importance of the Wnt pathway in these malignancies.
n/a
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