Testing How the Body Responds to the Drug CX-5461 (Pidnarulex) in Patients With Metastatic Solid Cancers
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients must have histologically confirmed solid tumors with metastatic disease that have progressed after ≥ 1 line of prior therapy and/or for whom no standard treatment is available that has been shown to improve survival. * Patients must have a molecular testing report to assess HRD mutation status prior to enrollment. * Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, with at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam). * Patients must have a tumor site amenable to biopsy. * Age ≥ 18 years of age. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥ 70%). * Absolute neutrophil count ≥ 1,500/mcL. * Hemoglobin ≥ 9 g/dL. * Platelets ≥ 100,0