A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors
This is an open-label Phase 1 dose escalation study of OMP-18R5 in subjects with a solid tumor 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-18R5 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-18R5 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. 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-18R5 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 Grade 3 (not including a Grade 3 infusion reaction that resolves in 24 hours) or 4 adverse event (DLT).
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors|
- To determine the safety of OMP-18R5 in subjects with previously treated solid tumors [ Time Frame: Subjects will be assessed for dose limiting toxicity from Days 0-28. Adverse events will be reported through 30 days after the last dose. ] [ Designated as safety issue: Yes ]
- To determine the pharmacokinetics of OMP-18R5 in subjects with previously treated solid tumors [ Time Frame: The first 8 weekly doses and following treatment termination ] [ Designated as safety issue: No ]The half-life, volume of distribution, and clearance will be determined.
- To determine the immunogenicity of OMP-18R5 in subjects with previously treated solid tumors [ Time Frame: Subjects will be assessed during screening, every 4 weeks, treatment termination, weekly for the first 4 weeks following d/c of study drug, Weeks 8 and 12 following d/c of drug. ] [ Designated as safety issue: No ]
- To assess the preliminary efficacy of OMP-18R5 in subjects with previously treated solid tumors [ Time Frame: Every 56 days until disease progression ] [ Designated as safety issue: No ]The response outcome in patients will be determined.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345201
|United States, California|
|UCLA Santa Monica Hematology-Oncology|
|Santa Monica, California, United States, 90404|
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|United States, Texas|
|South Texas Accelerated Research Therapeutics|
|San Antonio, Texas, United States, 78229|