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

NCT02482441 | Completed Phase 1

• 1 other identifier: 131R10-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Advanced Relapsed Tumors; Refractory Solid Tumors

Keywords

Advanced Solid Tumors and in Combination; FOLFIRI for Patients with Previously Treated Metastatic; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of dose limiting toxicities (DLTs)

  Subject will be assessed for DLTs during the evaluation window (28 days). Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined.

  DLTs during the evaluation (28 days)

Study Arms (2)

OMP-131R10 intravenous (in the vein) infusions

EXPERIMENTAL

OMP-131R10 will be administered IV on the first day of each 14-day cycle.

Drug: OMP-131R10; Drug: FOLFIRI

FOLFIRI (5-FU, irinotecan, leucovorin).

EXPERIMENTAL

dosing continues up to the 20 mg/kg dose level

Drug: OMP-131R10; Drug: FOLFIRI

Interventions

OMP-131R10 DRUG

There are 5 planned dose cohorts of OMP-131R10. Dose escalation will follow a traditional 3+3 framework. Treatment will be continued until progressive disease or unacceptable toxicity.

Also known as: OMP-131R10, IgG1 humanized monoclonal antibody

FOLFIRI (5-FU, irinotecan, leucovorin).; OMP-131R10 intravenous (in the vein) infusions

FOLFIRI DRUG

Treatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen.

FOLFIRI (5-FU, irinotecan, leucovorin).; OMP-131R10 intravenous (in the vein) infusions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• OncoMed Pharmaceuticals, Inc.: lead

Study Sites (7)

UCSF

San Francisco, California, 95115, United States

Location

University of Colorado Hospital Anschulz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Yale

New Haven, Connecticut, 06520-8028, United States

Location

Massachusetts General Hospital, Dana Farber Cancer Institute

Boston, Massachusetts, 02114, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

The Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

IFL protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: June 26, 2015
• Study Start: July 16, 2015
• Primary Completion: January 26, 2018
• Study Completion: March 28, 2018
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

US (7)