A Phase Ib Clinical Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 147
- Locations
- 10
- Primary Endpoint
- Determination of the safety and tolerability of BBI608 and BBI503 when administered in combination by assessing dose-limiting toxicities (DLTs)
Study Overview
Brief Summary
This is an open label, multi-center, phase 1 study of BBI608 and BBI503 administered orally in combination to patients with advanced solid tumors. The primary goal is to determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination regimen.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm A
Intervention: BBI608 (Drug)
Arm A
Intervention: BBI503 (Drug)
Outcomes
Primary Outcomes
Determination of the safety and tolerability of BBI608 and BBI503 when administered in combination by assessing dose-limiting toxicities (DLTs)
Time Frame: 4 weeks
Determination of the Recommended Phase 2 Dose of BBI608 and BBI503 when administered in combination based on DLT criteria, pharmacokinetic/pharmacodynamic observations and tolerability overall
Time Frame: 20 weeks
The overall tolerability assessment will include review of persistent grade 2 adverse events and review of adverse events occurring beyond the first cycle.
Secondary Outcomes
- Assessment of the preliminary anti-tumor activity by performing tumor assessments(16 weeks)
- Pharmacokinetic profile of BBI608 and BBI503 when administered in combination 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, 24 hours on day 1, cycles 1 and 2)
- Pharmacodynamic activity assessed by tumor biopsy(4 weeks)