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
Seven Cohorts of dose escalating VB-111 were completed with a total of 33 subjects enrolled.
An additional cohort (Cohort 8) has been added to include multiple doses of VB-111 within
disease specific subgroups (Neuroendocrine Tumor, Renal Cell Carcinoma). Subjects will
receive a single infusion of VB-111 every 2 months until progression. 18-36 subjects are
expected to be enrolled at 3 centers.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST)
Pierre Triozzi, Dr.
The Cleveland Clinic
United States: Food and Drug Administration
|Cleveland Clinic||Cleveland, Ohio 44195|
|Dana Farber/Brigham and Women's Cancer Center||Boston, Massachusetts 02215|
|UTHSC- CTRC and Institute for Drug Development||San Antonio, Texas 78229|