National Cancer Institute (NCI)
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.
PRIMARY OBJECTIVE: I. To assess whether pidnarulex induces a Rad51 response, which will be determined by an integral biomarker of percentage of cells with Rad51 nuclear foci in tumor biopsy specimens in patients with and without homologous repair deficiency (HRD) genetic mutations. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of pidnarulex. II. To determine the overall response rate (complete responses plus partial responses) in patients with advanced, refractory solid tumors. III. To measure the pharmacokinetics of pidnarulex. IV. To evaluate other DNA damage and repa…
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-nod…
Undergo biopsy
Undergo blood sample collection
Undergo CT
Undergo ECHO
Undergo MRI
Given IV
Arctuva estimate
Verify or correct the compensation shown for this listing.