Differential Thyroid Cancer
Conditions
Brief summary
The purpose of this study is to examine the safety and evaluate the response of VB-111 on DTC.
Interventions
DRUGVB-111
Sponsors
Vascular Biogenics Ltd. operating as VBL Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically confirmed advanced DTC (papillary, follicular, Hurthle cell); 2. Absence of sensitivity to therapeutic radioiodine; 3. Measurable disease, defined as at least one non-bony lesion that can be accurately measured in at least one dimension as confirmed with spiral CT scan 4. Life expectancy \>3 months; ECOG performance status (PS) 0, 1, or 2; Karnofsky performance status of ≥60%; 5. Subjects with a normal/acceptable hematological profile 6. Subjects with adequate renal function
Exclusion criteria
1. Presence of any of the following: * Radiotherapy or chemotherapy \<4 weeks prior to baseline visit; (Concurrent and/or prior therapy with octreotide will be allowed, provided tumor progression on this therapy has been demonstrated; Concurrent and/or prior therapy with biphosphonates will be allowed) * Radiotherapy to ≥25% of bone marrow; 2. Major surgery \<4 weeks prior to baseline visit; 3. Any other ongoing investigational agents within 4 weeks before dosing; 4. Subjects who suffered from an acute cardiac event within the last 12 months, including myocardial infarction, cardiac arrythmia, admission for unstable angina, cardiac angioplasty, or stenting; 5. QTc prolongation (defined as QTc interval ≥500 msecs) or other significant ECG abnormalities (e.g. frequent ventricular ectopy, evidence of ongoing myocardial ischemia); 6. Subjects with active vascular disease, either myocardial or peripheral; 7. Subjects with proliferative and/or vascular retinopathy; 8. Subjects with known active liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune) other than related to tumor metastases; 9. Subjects with known CNS metastatic disease (Exception: Subjects with treated CNS metastases stable by radiographic examinations \>6 months after definitive therapy administered, are eligible); 10. Subjects testing positive to one of the following viruses: HIV, HBV or HCV; 11. Any of the following conditions: * Serious or non-healing wound, ulcer, or bone fracture; * History of abdominal fistula, gastro-intestinal perforation, active diverticulitis, intra-abdominal abscess or gastro-intestinal tract bleeding within 6 months of dosing; * Any history of cerebrovascular accident (CVA) within 6 months of dosing; * Current use of therapeutic warfarin (Note: Low molecular weight heparin and prophylactic low-dose warfarin \[INR\<1.2 X ULN\] are permitted); * History of bleeding disorder, including subjects with hemophilia, disseminated intravascular coagulation (DIC), or any other abnormality of coagulation potentially predisposing subjects to bleeding; * Poorly controlled depression or anxiety disorder, or recent (within the previous 6 months) suicidal ideation; 12. Subjects with an ongoing requirement for 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 dosing; 13. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | 6 months |
| Objective response | 6 months |
Countries
United States
Outcome results
None listed