RecruitingMetastatic Malignant Solid Neoplasm

Testing How the Body Responds to the Drug CX-5461 (Pidnarulex) in Patients With Metastatic Solid Cancers

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

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.

Sponsor: National Cancer Institute (NCI)

You may qualify if…

✓ 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.

You may not qualify if…

✕ Patients must have recovered from clinically-significant adverse-events of their most recent cancer immunotherapy to grade 1 or less (with the exception for alopecia or lymphopenia).
✕ Eligibility of subjects receiving any medications or substances known to affect or with the potential to affect the activity of pidnarulex will be determined based on their potential to interact with the CYP3A4 isozyme. Specifically, subjects taking strong CYP3A4 inhibitors or strong CYP3A4 inducers will be excluded from participation in the trial. A list of agents that interact with CYP450 isoenzymes is provided. For medications or substances not listed, or in cases of uncertainty, the principal investigator may consult with a medical expert or a pharmacologist to make an informed decision regarding eligibility.
✕ History of allergic reactions attributed to inactive ingredients in the drug product.
✕ Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous.
✕ Pregnant and lactating women are excluded from this trial. The exclusion is based on the potential risk of adverse effects of pidnarulex on fetal development and newborn health. The safety of pidnarulex has not been established in pregnant or lactating women, and there is a possibility that the drug could cause harm to the developing fetus or be transferred to the infant through breast milk. Additionally, the physiological changes that occur during pregnancy and lactation could alter the pharmacokinetics and pharmacodynamics of pidnarulex, leading to unpredictable drug exposure and efficacy.
✕ Patients with chronic, active HBV or HCV infections that require ongoing antiviral treatment will be excluded from the trial. This exclusion is due to the potential for drug interactions with the study medication and the risk of exacerbating liver disease.
✕ Patients with cirrhosis, regardless of the etiology, will be excluded from participation in the trial. This is due to the increased risk of complications and adverse events associated with the study medication in this population.
✕ Presence of known photosensitivity disorders (xeroderma pigmentosa, porphyria etc.). Patients who do not agree to use sunglasses and sun blocker (with sun protection factor 50 \[SPF50\] to ultraviolet B \[UVB\] and a high degree of protection against ultraviolet A \[UVA\]) if exposed to sunlight during the course of the study and for 3 months after the last dose are not eligible. Appropriate sunscreen products will be provided. Patients who plan to use sun beds or tanning booths during the course of the study and within 3 months after the last dose are not eligible.

Where it's recruiting

Maryland

Bethesda

Source: ClinicalTrials.gov · NCT06606990 · last updated 2026-05-13