A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BGC515 Capsules in Patients With Advanced Solid Tumors
BridGene Biosciences Inc.
Summary
The goal of this open-label, dose escalation and dose expansion Phase I clinical trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BGC515 administered once daily in 3 weeks cycles in solid tumor patients.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Having signed the written Informed Consent Form * Male or female aged ≥18 years * Life expectancy ≥12 weeks * Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1 * Dose escalation phase: Histologically or cytologically confirmed locally advanced or metastatic mesothelioma (MM), epithelioid hemangioendothelioma (EHE), or other advanced solid tumors who have experienced progressive disease or treatment intolerability after receiving the standard-of-care, or refuse to receive or have no access to the standard-of-care * Dose expansion phase: Histologically or…
Interventions
- DrugBGC515
Capsules for oral administration
Location
- MD Anderson Cancer CenterHouston, Texas