RecruitingPhase 1NCT05687110

Studying the Safety and Determining the Optimal Dose of Novobiocin in Patients With Tumors That Have Alterations in DNA Repair Genes

A Phase 1 Study of the Polymerase Theta (POLθ) Inhibitor Novobiocin in BRCA- Mutant and Other DNA Damage Repair-Deficient Solid Tumors


Sponsor

National Cancer Institute (NCI)

Enrollment

43 participants

Start Date

Jul 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety, side effects, and best dose of novobiocin in treating cancer patients with alterations in deoxyribonucleic acid (DNA) repair genes. Novobiocin is an antibiotic that blocks the activity of a protein called DNA polymerase theta, which helps repair DNA that has become damaged as cells grow and divide. Cancer cells that cannot repair their damaged DNA die. This medication may help shrink or stabilize cancer with a mutation in DNA repair genes.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Biopsy Procedure, a procedure called Biospecimen Collection, and others for people with metastatic malignant solid neoplasm and unresectable malignant solid neoplasm. The study is currently recruiting participants at 23 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREDiagnostic Imaging Testing

Undergo medical imaging scans

BIOLOGICALNovobiocin Sodium

Given PO


Locations(23)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

National Cancer Institute Developmental Therapeutics Clinic

Bethesda, Maryland, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

NYU Langone Hospital - Long Island

Mineola, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

University of Washington Medical Center - Montlake

Seattle, Washington, United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT05687110


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