Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06606990

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

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

40

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have histologically confirmed solid tumors with metastatic disease that have progressed after  1 line of prior therapy or have no standard treatment available that improves survival.
  • Patients must have a molecular test report for homologous repair deficiency (HRD) mutation status before enrollment.
  • Patients must have measurable disease with at least one lesion  20 mm by chest x-ray or  10 mm by CT, MRI, or clinical exam.
  • Patients must have a tumor site suitable for biopsy.
  • Must be 18 years of age or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky  70%).
  • Absolute neutrophil count  1,500/mcL.
  • Hemoglobin  9 g/dL.
  • Platelets  100,000/mcL.
  • Total bilirubin  1.5 times institutional upper limit of normal (ULN), with exceptions for Gilbert disease up to 3 mg/dL.
  • INR or aPTT  1.5 times ULN (supplementation allowed).
  • AST/ALT  3 times ULN, or up to 5 times ULN if liver involved.
  • Potassium, magnesium, and ionized/corrected calcium levels  lower limit of normal; supplementation allowed.
  • Creatinine  1.5 times ULN or creatinine clearance  60 ml/min.
  • Oxygen saturation > 90% on room air.
  • Prior treatment completed  4 weeks or  5 half-lives prior to enrollment (exceptions apply).
  • HIV patients on effective therapy with undetectable viral load within 6 months.
  • Patients with chronic hepatitis B must have undetectable viral load.
  • Patients with treated hepatitis C must be cured.
  • Treated brain metastases allowed if no progression for  1 month.
  • Prior or concurrent malignancies allowed if not interfering with study safety or efficacy.
  • Cardiac risk assessment must classify patients as NYHA class 2B or better.
  • Women of childbearing potential and men must agree to use contraception before and during the study and for 6 months after.
  • Willingness to provide blood and biopsy samples.
  • Ability to understand and sign informed consent.
Not Eligible

You will not qualify if you...

  • Patients must have recovered to grade 1 or less from significant adverse events of recent cancer immunotherapy (except alopecia or lymphopenia).
  • Use of strong CYP3A4 inhibitors or inducers disallowed due to drug interactions.
  • History of allergic reactions to inactive ingredients in the study drug.
  • Uncontrolled illness or other significant conditions making the study unsafe.
  • Pregnant or breastfeeding women.
  • Chronic, active hepatitis B or C requiring ongoing treatment.
  • Patients with cirrhosis of any cause.
  • Known photosensitivity disorders or unwillingness to use sun protection measures.
  • Plans to use tanning beds or sun lamps during or up to 3 months after treatment.
  • Active ocular surface disease or history of cicatricial conjunctivitis evaluated by an ophthalmologist.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Cancer Institute Developmental Therapeutics Clinic

Bethesda, Maryland, United States, 20892

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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