A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10

Completed · Phase 1

Conditions studied: Advanced Relapsed Tumors, Refractory Solid Tumors

In brief

This is an open-label Phase 1a/b dose-escalation study to assess the safety, tolerability, and PK of OMP-131R10 as a single agent for advanced solid tumors and in subjects with metastatic colorectal cancer.

Key facts

Study ID

NCT02482441

Run by

OncoMed Pharmaceuticals, Inc.

People needed

50

Starts

2015-07-16

Expected to finish

2018-03-28

Last updated by the study team

2020-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following criteria to be eligible for the study:
• Phase 1a portion: Histologically confirmed advanced relapsed or refractory solid tumors that have exhausted standard of care therapy or either refuse or are not considered to be candidates for any remaining standard therapy.
• Age ≥18 years
• ECOG performance status 0 or 1 (see Appendix B)
• Must have evaluable disease per RECIST 1.1. (see Appendix C)
• Subjects must have Formalin-Fixed, Paraffin-Embedded (FFPE) tissue available either archived or fresh core or punch needle biopsied at study entry (two fresh cores/punches preferred whenever possible).
• Must have received their last anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy, or herbal therapy at least 3 weeks or 5 half-lives (for systemic agents), whichever is shorter, from initiation of study treatment.
• Platelets >100,000/mL without transfusions in the past 7 days
• Total bilirubin within 1.5x institutional upper limit of normal (ULN)
• AST (SGOT) and ALT (SGPT) <3 X institutional ULN
• Patients with documented liver metastases: AST (SGOT) and/or ALT (SGPT) ≤ 5 × ULN
• Albumin ≥ 3.0 g/dL
• Creatinine <1.5 X institutional ULN OR
• Creatinine clearance >50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal

You may not qualify if…

• Subjects who meet any of the following criteria will not be eligible for participation in the study:
• Currently receiving any therapeutic treatment for their malignancy including other investigational agents
• Uncontrolled seizure disorder, active neurologic disease, or active CNS involvement except for individuals who have previously treated CNS metastases, are asymptomatic, and have no requirement for a corticosteroid dose (indicated to reduce brain edema) that is equivalent to a prednisone dose of >10mg orally per day or anti-seizure medication for at least 4 weeks prior to first dose of study drug.
• History of a Grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy
• Significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women or nursing women
• Subjects with congestive heart failure with New York Heart Association Classification III, or IV (see Appendix D)
• Known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease

Where it is running

• UCSF — San Francisco, California, United States
• University of Colorado Hospital Anschulz Cancer Pavilion — Aurora, Colorado, United States
• Yale — New Haven, Connecticut, United States
• Massachusetts General Hospital, Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Duke University — Durham, North Carolina, United States
• The Sarah Cannon Research Institute — Nashville, Tennessee, United States
• M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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