This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion uses Bayesian optimal interval (BOIN) design to escalate and determine the MTD and/or RP2D with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and to further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies for VBC108.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
VBC108
City of Hope Medical Center
Duarte, California, United States
RECRUITINGSTART Midwest, LLC
Grand Rapids, Michigan, United States
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Time frame: From time of first dose of VBC108 to end of DLT period ( 21 days)
Incidence of Serious Adverse Events
Number of patients with serious adverse events by system organ class and preferred term
Time frame: From time of Informed Consent to 30 days post last dose of VBC108
Incidence of Adverse Events (AEs)
Number of patients with adverse events by system organ class and preferred term
Time frame: From time of Informed Consent to 30 days post last dose of VBC108
Objective Response Rate (ORR)
The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)
Time frame: From first dose of VBC108 to disease progression or death, up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Laura and Issac Perlmutter Cancer Center
New York, New York, United States
NOT_YET_RECRUITINGNext Oncology - Oncology
San Antonio, Texas, United States
RECRUITINGNEXT Oncology Virginia
Fairfax, Virginia, United States
RECRUITINGGenesisCare North Shore
St Leonards, New South Wales, Australia
RECRUITINGOne Clinical Research
Perth, Western Australia, Australia
NOT_YET_RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing GoBroad Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGZhongshan Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITING...and 2 more locations