ORB-021 In Patients With Advanced Solid Tumors
Orionis Biosciences Inc
Summary
The goal of this clinical research study is to determine if an investigational new drug, named ORB-021, developed by Orionis Biosciences is safe and can be tolerated in people diagnosed with an advanced solid tumor. The study also aims to find the biologically optimal dose of the study medicine by assessing the safety and potential activity in the treatment of solid tumors. There are three phases to this study: screening, treatment and end of treatment.
Description
ORB-021 is a complex engineered biologic molecule that targets cytokine activation specifically to certain immune cells which may have benefit in solid tumors. The cytokine in ORB-021 is inactive to cells expressing the receptor but confers full activity to individual cells when also bound to the target, thereby markedly reducing the potential for toxicities caused by the cytokine. ORB-021 is administered by intravenous (IV) infusion/injection.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: All patients must meet the following criteria for inclusion: 1. Age 18 years or older 2. Patients with evidence of recurrent or refractory solid tumors deemed medically safe to undergo serial biopsies. 3. Must have received or be ineligible for all standard of care therapies as deemed appropriate by the treating physician. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 5. Adequate organ and marrow function as defined below: * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (\> 1500 per mm3) * Platelet count ≥ 7…
Interventions
- DrugORB-021
ORB-021 is dosed via IV infusion
Locations (2)
- Honor Health Clinical ResearchScottsdale, Arizona
- MDACHouston, Texas