A Phase I Study to Assess the Safety and Distribution of VB-111 in Patients With Advanced Metastatic Cancer

A Phase I, Open-Label, Dose Ranging Study to Assess the Safety and Distribution of Single or Multiple Doses of VB-111 in Patients With Advanced Metastatic Cancer

Aim of the study is to evaluate the safety and find the maximal tolerated dose of VB-111 in Patients with Advanced Metastatic Cancer

Study Overview

• Status: Unknown
• Conditions: Advanced and/or Metastatic Solid Organ Cancer
• Intervention / Treatment: Drug: VB-111

Detailed Description

Nine Cohorts of dose escalating VB-111 were completed with a total of 56 subjects enrolled.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber/Brigham and Women's Cancer Center
  • Ohio
    • Cleveland, Ohio, United States, 44129
      • Cleveland Clinic
  • Texas
    • San Antonio, Texas, United States, 78229
      • UTHSC- CTRC and Institute for Drug Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients ≥18 years of age
• Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. For Cohort 8, malignancy will include only NET or RCC.
• Karnofsky performance status of ≥70%
• Patients with an adequate hematological profile
• Patients with an adequate renal function
• Males and Females of childbearing potential must utilize a standard contraception method
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Pregnant or breastfeeding patients
• Patients, who suffered from an acute cardiac event within the last 12 months
• Patients with active vascular disease, either myocardial or peripheral
• Patients with proliferative and/or vascular retinopathy
• Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune)
• Patients with known CNS metastatic disease
• Patients testing positive to one of the following viruses: HIV, HBV or HCV
• Patients receiving chemotherapy or radiotherapy within the last 4 weeks before enrolment
• Patients that have undergone major surgery within the last 4 weeks before enrolment
• Patients may not have received anti-angiogenic therapy within the previous 8 weeks before enrolment.
• Patients may not have received any other investigational agent within 4 weeks before enrolment.
• Patients with an ongoing requirement for an immunosuppressive treatment, including the use of glucocorticoids or cyclosporin, or with a history of chronic use of any such medication within the last 4 weeks before enrolment
• Uncontrolled 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort	Drug: VB-111; A single intravenously infusion of diluted VB-111 should be administered 1 ml/minute

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST)	2 months

Collaborators and Investigators

• Sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics
• Investigators: Principal Investigator: Pierre Triozzi, Dr., The Cleveland Clinic; Principal Investigator: Andrew Brenner, MD, UTHSC- CTRC and Institute for Drug Development

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: November 15, 2007
• First Submitted That Met QC Criteria: November 15, 2007
• First Posted (Estimate): November 16, 2007

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 26, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: GT-111001 (VB-111)