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A Dose Escalation Study of OMP-54F28 in Subjects With Solid Tumors

NCT01608867 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-08-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

OMP-54F28

dose escalation of 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • OncoMed Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-08-31
Completion
2017-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01608867 on ClinicalTrials.gov