A Phase Ib/II Clinical Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 165
- Locations
- 8
- Primary Endpoint
- Determination of the safety and tolerability of BBI503 administered in combination with selected anti-cancer therapeutics by assessing dose-limiting toxicities (DLTs)
Study Overview
Brief Summary
This is an open label, multi-center, Phase 1/2 study of BBI503 administered in combination with selected anti-cancer therapeutics in adult patients with advanced cancer. The goal of the study is to determine the safety, tolerability, and RP2D of BBI503 in combination with each of the selected anti-cancer agents.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- 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
Combo with Capecitabine
Intervention: BBI503 (Drug)
Combo with Capecitabine
Intervention: Capecitabine (Drug)
Combo with Doxorubicin
Intervention: BBI503 (Drug)
Combo with Doxorubicin
Intervention: Doxorubicin (Drug)
Combo with Nivolumab (US only)
Intervention: BBI503 (Drug)
Combo with Nivolumab (US only)
Intervention: Nivolumab (Drug)
Combo with Pembrolizumab
Intervention: BBI503 (Drug)
Combo with Pembrolizumab
Intervention: Pembrolizumab (Drug)
Combo with Paclitaxel
Intervention: BBI503 (Drug)
Combo with Paclitaxel
Intervention: Paclitaxel (Drug)
Combo with Sunitinib
Intervention: BBI503 (Drug)
Combo with Sunitinib
Intervention: Sunitinib (Drug)
Outcomes
Primary Outcomes
Determination of the safety and tolerability of BBI503 administered in combination with selected anti-cancer therapeutics by assessing dose-limiting toxicities (DLTs)
Time Frame: 3 or 4 weeks based on the cycle of the selected anti-cancer therapeutics
Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs)
Time Frame: 3 or 4 weeks based on the cycle of the selected anti-cancer therapeutics
Secondary Outcomes
- Pharmacokinetic profile of BBI503 administered in combination with selected anti-cancer therapeutics as assessed by maximum plasma concentration and area under the curve(0, 1, 2, 3, 4, 6, 8, 10, 24 hours on day 1, cycles 1 and 2)
- Pharmacodynamic activity of BBI503 administered in combination with selected anti-cancer therapeutics as assessed by biomarker analysis(3 or 4 weeks based on the cycle of the selected anti-cancer therapeutics)
- Assessment of the preliminary anti-tumor activity by performing tumor assessments every 8 weeks (Phase 2 portion)(6 months)