A Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Cancers
- Conditions
- Cancer
- Interventions
- Registration Number
- NCT02467361
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
This is an open label, multi-center, Phase 1/2 study of BBI608 administered in combination with immunotherapy in adult patients with advanced cancers. The goal of the study is to determine the RP2D of BBI608 in combination with each of the immunotherapeutic agents.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combo with Ipilimumab BBI608 - Combo with Nivolumab BBI608 - Combo with Nivolumab Nivolumab - Combo with Pembrolizumab BBI608 - Combo with Ipilimumab Ipilimumab - Combo with Pembrolizumab Pembrolizumab -
- Primary Outcome Measures
Name Time Method Determination of the safety and tolerability of BBI608 administered in combination with selected immunotherapeutic agent by assessing dose-limiting toxicities (DLTs) 6 weeks Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs) 6 weeks
- Secondary Outcome Measures
Name Time Method Assessment of the preliminary anti-tumor activity by performing tumor assessments every 8 weeks (Phase 2 portion) 6 months Evaluation of anti-tumor activity will be performed according to Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST).
Pharmacokinetic profile of BBI608 administered in combination with the selected immunotherapeutic agent as assessed by maximum plasma concentration and area under the curve -5min, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours on day 1, cycles 1 and 2 Pharmacodynamic activity of BBI608 administered in combination with the selected immunotherapeutic agent as assessed by biomarker analysis 6 months Histopathology and Cancer Stem Cell assays will be performed to provide information of the biomarkers on biopsied patient tumor tissue, and archival samples.
Trial Locations
- Locations (8)
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Emory University Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
University of Chicago Medicine Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Institute for Translational Oncology Research
🇺🇸Greenville, South Carolina, United States