NCT02467361

A Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Cancers

A Phase Ib/II Clinical Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors to Adult Patients With Advanced Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	BBI608	Patients in this trial will receive BBI608 at assigned dose-levels according to the study arm the patient is enrolled into. BBI608 Dose Level 1: 240 mg twice daily, Dose Level 2: 480 mg twice daily. The assigned dose of BBI608 will be administered twice daily with approximately 12 hours between doses.
DRUG	Ipilimumab	Ipilimumab 3 mg/kg is administered intravenously over 90 minutes every 21 days for a total of 4 doses.
DRUG	Nivolumab	Nivolumab 3 mg/kg is administered as an intravenous infusion over 60 minutes every 14 days.
DRUG	Pembrolizumab	Pembrolizumab 2 mg/kg is administered as an intravenous infusion over 30 minutes once every 21 days.

Timeline

• Start date: 2015-08-01
• Primary completion: 2021-01-29
• Completion: 2021-01-29
• First posted: 2015-06-10
• Last updated: 2023-11-14

Locations

8 sites across 1 country: United States