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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06606990
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Pidnarulex — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pidnarulex)
    Patients receive pidnarulex IV over 60 minutes on days 1 and 8 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, biopsy, and collection of blood samples throughout the trial. Patients may undergo ECHO at screening and then as clinically indicated.

Primary Outcome Measure

RAD51 response [ Time Frame: Up to 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Cancer Institute Developmental Therapeutics ClinicBethesdaMaryland20892
Site Public Contact
800-411-1222
A P. Chen (PRINCIPAL_INVESTIGATOR)

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By research site
National Cancer Institute Developmental Therapeutics Clinic· Bethesda, MD

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