Clinical trial · Interventional
A Study of BBI503 in Advanced Solid Tumors, or BBI503/ Sorafenib in Advanced Hepatocellular Carcinoma
A Phase I Study of BBI503 Monotherapy in Patients With Advanced Solid Tumors, or BBI503 Plus Sorafenib Combination Therapy in Patients With Advanced Hepatocellular Carcinoma
NCT02354898CI-TRIAL-00057730completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, multicenter, phase 1 dose escalation study of BBI503 monotherapy, or BBI503 in combination with Sorafenib. This study population is adult patients with advanced solid tumors in monotherapy, or adult patients with advanced hepatocellular carcinoma in combination therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BBI503 | Drug | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BBI503, BBI503 and Sorafenib
- interventionNames
- Drug: BBI503
- Drug: Sorafenib
Primary outcomes (3)
- measure
- Determine of the Maximum Tolerated Dose (MTD) of BBI503 monotherapy and in combination with Sorafenib by assessing dose-limiting toxicities (DLTs)
- timeFrame
- 36 days
- measure
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- Approximately 7 months
- measure
- Pharmacokinetic profile of BBI503
- timeFrame
- 37 days
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of written informed consent. * ≥ 20 years of age * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI503 dose * Females of childbearing potential must have a negative serum pregnancy test * Adequate organ function * Life expectancy ≥ 3 months Exclusion Criteria: * Any known symptomatic or untreated brain metastases * Pregnant or breastfeeding * Crohn's disease, ulcerative colitis extensive gastric and small intestine resection * Unable or unwilling to swallow BBI503 daily * Uncontrolled concurrent disease * Received other investigational drugs within 4 weeks prior to first dose * Prior treatment with BBI503
References
Publications (0)
Data not yet available
No reference posted for this study.