A Phase 1 Study of OMP-305B83 in Subjects With Solid Tumors

NCT02298387 | Completed Phase 1

• 1 other identifier: B83-001
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 4

Brief Summary

This is an open-label Phase 1 dose escalation and expansion study of OMP-305B83 in subjects with previously treated solid tumors. Study includes a dose escalation phase and expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy.

Conditions

Advanced Solid Tumor Malignancies

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicities (DLTs)

  Number of subjects with a DLT

  Subjects will be assessed for DLTs from Days 0-21. Adverse events will be reported through 30 days after discontinuation of treatment

• Incidence of adverse events

  Number of subjects with adverse events

  Up to 2 years

Secondary Outcomes (1)

• Pharmacokinetics (PK) - AUC, Clearance, volume of distribution, apparent half-life

  PK analyses at various time points following the 1st and 3rd doses, pre-dose at Day 84 and every 9 weeks while on study, at treatment term, every 6 weeks for 12 weeks post termination

Study Arms (1)

OMP-305B83

EXPERIMENTAL

The dose levels of OMP-305B83 will be 0.5, 1.0, 2.5, 5 and 10 mg/kg administered IV once every 3 weeks.

Drug: OMP-305B83

Interventions

OMP-305B83 DRUG

intravenous (in the vein) infusions

Also known as: bispecific monoclonal antibody

OMP-305B83

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have a histologically confirmed malignancy that is metastatic or unresectable for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit or they must be ineligible to receive such therapy and/or have declined all such therapy. In addition, subjects must have a tumor that is at least 1 cm in a single dimension and is radiographically apparent on CT or MRI.
• FFPE tumor tissue either fresh core needle biopsied or archived (two FFPE cores preferred whenever possible) is required for participation in the study. If fresh tissue is obtained, the core biopsy must be done at least ≥7 days prior to Day 0.
• Subjects must have received their last chemotherapy, non-anti-VEGF biologic, or investigational therapy at least 4 weeks prior to enrollment, 6 weeks if the last regimen included BCNU or mitomycin C, and 8 weeks if the last regimen was an anti-VEGF therapy
• Age \>21 years
• ECOG performance status \<2
• Life expectancy of more than 3 months
• Subjects must have adequate organ and marrow function as defined below:
• Absolute neutrophil count \>1000/mL (without a colony stimulating factor within the last 2 weeks)
• Hemoglobin \>10.5 g/dL (without erythropoietin or blood transfusion within the last 2 weeks)
• Platelets \>100,000/mL (without platelet transfusion within the last 2 weeks)
• Total bilirubin \<1.5 X institutional upper limit of normal (ULN)
• AST (SGOT) and ALT (SGPT) \<2 X institutional ULN (for subjects with hepatic metastases \<5 X institutional ULN)
• INR and PTT within 1.5 X institutional ULN
• Proteinuria \< trace
• Creatinine \<1.5 X institutional ULN OR

You may not qualify if:

• Subjects receiving any other investigational agents
• Subjects who have received an anti-DLL4 antibody, or an anti-DLL4/VEGF bispecific antibody Subjects who have received prior anti-VEGF therapy are eligible, unless they have residual serious adverse events related to their anti-VEGF therapy.
• Subjects with a history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess; clinical signs or symptoms of GI obstruction and/or requirement for parenteral hydration or nutrition. In addition, subjects with other known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease.
• Subjects with brain metastases (subjects must have a CT scan or MRI of the head within 28 days prior to enrollment to rule out brain metastases), uncontrolled seizure disorder, or active neurologic disease
• History of a significant 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 known HIV infection
• Known bleeding disorder or coagulopathy
• Subjects receiving heparin, warfarin, or other similar anticoagulants, except for subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
• Subjects with ascites or pleural effusion requiring drainage within the last 28 days.
• Subjects with a blood pressure of \>140/90 mmHg.
• Subjects with squamous cell carcinoma of the lung
• Subjects having undergone a major surgery within the last 6 weeks
• New York Heart Association Classification II, III, or IV (see APPENDIX D)

Sponsors & Collaborators

• OncoMed Pharmaceuticals, Inc.: lead

Study Sites (4)

Oncology Research Associates, PLLC d/b/a Pinnacle Oncology Hematology

Scottsdale, Arizona, 85258, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

University of Oklahoma Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Interventions

navicixizumab; Antibodies, Bispecific

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• David Smith, MD,FACP

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 24, 2014
• Study Start: December 22, 2014
• Primary Completion: May 23, 2017
• Study Completion: September 8, 2017
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

US (4)