OncoMatch/Clinical Trials/NCT06607939
ORB-021 In Patients With Advanced Solid Tumors
Is NCT06607939 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ORB-021 for advanced solid tumors cancer.
Treatment: ORB-021 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard of care therapies
Must have received or be ineligible for all standard of care therapies as deemed appropriate by the treating physician.
Cannot have received: any other anticancer therapy
Any other anticancer therapy (eg, chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, radiation therapy, intravesical therapy, investigational agent) within 28 days or 5 half-lives (whichever is shorter) of the study treatment
Cannot have received: investigational agent
Patients who are receiving any other investigational agents
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1.5 × 10^9/L (> 1500 per mm3); Platelet count ≥ 75 × 10^9/L (> 75,000 per mm^3)
Kidney function
Creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula
Liver function
Serum bilirubin ≤ 1.5 × institutional ULN; AST (SGOT)/ALT (SGPT) ≤ 2.5 × institutional ULN for patients without known liver metastases and up to 5 x institutional ULN for patients with known liver metastases.
Adequate organ and marrow function as defined below: * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (> 1500 per mm3) * Platelet count ≥ 75 × 10^9/L (> 75,000 per mm^3) * Serum bilirubin ≤ 1.5 × institutional ULN. * AST (SGOT)/ALT (SGPT) ≤ 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Honor Health Clinical Research · Scottsdale, Arizona
- MDAC · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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