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Trial record 1 of 1 for:    b83-001
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A Phase 1 Study of OMP-305B83 in Subjects With Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02298387
First received: November 10, 2014
Last updated: July 25, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Advanced Solid Tumor Malignancies Drug: OMP-305B83 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation and Expansion Study of OMP-305B83 in Subjects With Solid Tumors

Further study details as provided by OncoMed Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Incidence of dose limiting toxicities (DLTs) [ Time Frame: Subjects will be assessed for DLTs from Days 0-21. Adverse events will be reported through 30 days after discontinuation of treatment ]
    Number of subjects with a DLT

  • Incidence of adverse events [ Time Frame: Up to 2 years ]
    Number of subjects with adverse events


Secondary Outcome Measures:
  • Pharmacokinetics (PK) - AUC, Clearance, volume of distribution, apparent half-life [ Time Frame: 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 ]
    Area under the plasma concentration-time curve, measurement of renal clearance from the body, volume of distribution, apparent half life of antibody


Enrollment: 71
Study Start Date: December 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OMP-305B83
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
intravenous (in the vein) infusions
Other Name: bispecific monoclonal antibody

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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
  4. Age >21 years
  5. ECOG performance status <2
  6. Life expectancy of more than 3 months
  7. 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
    • Creatinine clearance >60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal
  8. Women of childbearing potential must have had a prior hysterectomy or have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug. Men must also agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and from study entry through at least 6 months after discontinuation of study drug. Should a woman enrolled in the study or a female partner of a man enrolled in the study become pregnant or suspect she is pregnant while participating in this study or within 6 months after discontinuation of study, she should inform the Investigator immediately.
  9. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  1. Subjects receiving any other investigational agents
  2. 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.
  3. 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.
  4. 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
  5. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
  6. 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
  7. Pregnant women or nursing women
  8. Subjects with known HIV infection
  9. Known bleeding disorder or coagulopathy
  10. 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.
  11. Subjects with ascites or pleural effusion requiring drainage within the last 28 days.
  12. Subjects with a blood pressure of >140/90 mmHg.
  13. Subjects with squamous cell carcinoma of the lung
  14. Subjects having undergone a major surgery within the last 6 weeks
  15. New York Heart Association Classification II, III, or IV (see APPENDIX D)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02298387

Locations
United States, Arizona
Oncology Research Associates, PLLC d/b/a Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Oklahoma
University of Oklahoma Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
Investigators
Principal Investigator: David Smith, MD,FACP University of Michigan
  More Information

Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02298387     History of Changes
Other Study ID Numbers: B83-001
Study First Received: November 10, 2014
Last Updated: July 25, 2017

Additional relevant MeSH terms:
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 27, 2017