OncoMatch/Clinical Trials/NCT06606990
Testing How the Body Responds to the Drug CX-5461 (Pidnarulex) in Patients With Metastatic Solid Cancers
Is NCT06606990 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Pidnarulex for metastatic malignant solid neoplasm.
Treatment: Pidnarulex — This phase I trial tests the safety, side effects, and best dose of pidnarulex (CX-5461) in treating patients with solid tumors that have spread from where it first started (primary site) to other places in the body (metastatic). Pidnarulex is an oral inhibitor of ribonucleic acid polymerase I, with potential antineoplastic activity. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill cancer cells.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/mcL; Hemoglobin ≥ 9 g/dL; Platelets ≥ 100,000/mcL
Kidney function
Creatinine ≤ 1.5 x institutional ULN OR creatinine clearance ≥ 60 ml/min (Cockcroft-Gault)
Liver function
Total bilirubin ≤ 1.5 x institutional ULN (Gilbert disease up to 3 mg/dl allowed); AST/ALT ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement)
Cardiac function
NYHA Functional Classification class 2B or better
Absolute neutrophil count ≥ 1,500/mcL. Hemoglobin ≥ 9 g/dL. Platelets ≥ 100,000/mcL. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). (However, patients with known Gilbert disease who have serum bilirubin level of up to 3 mg/dl may be enrolled). Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x institutional ULN. (AST and/or ALT ≤ 5 x ULN for patients with liver involvement). Creatinine ≤ 1.5 x institutional ULN OR creatinine clearance levels ≥ 60 ml/min based on the Cockcroft-Gault formula. NYHA Functional Classification class 2B or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Cancer Institute Developmental Therapeutics Clinic · Bethesda, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify