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

VBL Therapeutics

Status and phase

Unknown

Phase 1

Conditions

Advanced and/or Metastatic Solid Organ Cancer

Treatments

Drug: VB-111

Study type

Interventional

Funder types

Industry

Identifiers

GT-111001 (VB-111)

Details and patient eligibility

About

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

Full description

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

Enrollment

48 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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