Testing the Drug CX-5461 for Treating Metastatic Solid Tumors

https://www.facingourrisk.org/research-clinical-trials/study/431 /testing-the-drug-cx-5461-for-treating-metastatic-solid-tumors

Clinicaltrials.gov identifier:
NCT06606990 (https://clinicaltrials.gov/show/NCT06606990)

Treatment
Phase 1 study for treatment of advanced solid tumors

Study Contact Information:

National Cancer Institute Developmental Therapeutics Clinic
Phone: 800-411-1222
Phone: 240-781-3400
Fax: 301-451-5625
[email protected]
Principal Investigator: A P. Chen

About the Study

This early-phase study is looking at the safety, side effects, and best dose of the medication pidnarulex for treating advanced or metastatic cancers. Pidnarulex blocks a certain protein called Pol 1 that cells need to repair DNA damage.

This study has three goals:

To learn if pidnarulex is effective.
To find out how safe pidnarulex is to take and how well people with advanced cancer respond to the drug.
To measure how pidnarulex is processed by the body and if the drug affects other DNA repair systems in the body.

What the Study Involves

There is one arm to this study.

All people enrolled in this study will receive pidnarulex intravenously (IV) over 60 minutes on days 1 and 8 of a 28 day cycle.
Participants will undergo CT or MRI scans, biopsy, and collection of blood samples throughout the trial.
Participants may undergo an ultrasound of their heart at screening and then as needed over the course of the study.

Participants will stay on this treatment until their cancer gets worse or they have side effects that require stopping the medication. Participants will be followed for up to 3 years.

For people out of town, travel expenses and accommodations may be covered by the study.

This Study is Open To:

In order to participate, people must meet all of the following:

Age 18 or older.
Diagnosed with metastatic cancer that has come back or gotten worse after at least one prior round of treatment.
Have no treatments available that have been shown to improve survival.
Must have tumor testing for a biomarker known asi HRD.
Must have metastasis that can be measured with CT scan, MRI, or clinical exam and that can be sampled through a biopsy.
Must have completed prior treatment at least 4 weeks before enrollment in this study.
Participants with brain or CNS metastasis must have been treated and have no evidence of getting worse for at least 1 month.
Must have adequate heart function.
Participants who may become pregnant and male participants must agree to use birth control.
Must agree to use sunglasses and sunblock (with sun protection factor 50).

Visit Clinicaltrials.gov for the full eligibility listing.

This Study is Not Open To:

People with any of the following cannot join the study:

Any severe health effects from their most recent cancer treatment (with the exception of hair loss or low white blood cell levels).
Uncontrolled illness not related to the cancer diagnosis or any other significant health concerns that would make participation unreasonably hazardous.
Pregnant or breastfeeding.
Certain types of disease of the eye.

Visit Clinicaltrials.gov for the full list of exclusions.

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.