NCT06607939 ORB-021 In Patients With Advanced Solid Tumors

Trial Parameters

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Brief 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.

Eligibility Criteria

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 ≥ 75 × 109/L (\> 75,000 per mm\^3) * Serum bilirubin less than or equal to 1.5 × institutional upper limit of normal (ULN). * AST (SGOT)/ALT (SGPT) less than or equal to 2.5 × institutional ULN for patients without known liver metastases and up to 5 x institutional ULN for patients with known liver metastases. * Creatinine clearance (CL) \> 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976

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