Actively Recruiting
Studying the Safety and Determining the Optimal Dose of Novobiocin in Patients With Tumors That Have Alterations in DNA Repair Genes
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
43
Participants Needed
23
Research Sites
164 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 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.
CONDITIONS
Official Title
Studying the Safety and Determining the Optimal Dose of Novobiocin in Patients With Tumors That Have Alterations in DNA Repair Genes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have metastatic or unresectable solid tumors with no effective standard treatments
- Tumors must have confirmed mutations in specific DNA repair genes as identified by certified testing
- Patients may have had any number of prior therapies
- Patients with cancers approved for PARP inhibitors must have used them; others may be PARP inhibitor-na�efve or resistant
- Age 18 years or older
- ECOG performance status of 0 to 2 (Karnofsky score 60%)
- Adequate blood counts and liver and kidney function
- Controlled HIV, hepatitis B, or hepatitis C infections under specified conditions
- Patients with treated or stable brain metastases may participate
- Patients with prior or concurrent cancers that do not interfere with safety or efficacy assessments
- New York Heart Association functional class 2B or better
- Tumors must be suitable for biopsies, and patients must agree to biopsies before and during treatment
- Use of effective contraception by women of child-bearing potential and men throughout the study and for 4 months after
- Ability to understand and sign informed consent, including participants with legally authorized representatives
You will not qualify if you...
- Chemotherapy or radiotherapy within 2 weeks (6 weeks for certain drugs) before study entry
- Unresolved side effects from prior cancer treatments above grade 1 (except hair loss)
- Use of other investigational agents
- Allergies to novobiocin or similar compounds
- Use of medications that strongly affect certain liver enzymes or drug transporters
- Use of herbal supplements with liver toxicity risk
- Use of medications that prolong QT interval or risk serious heart rhythm problems
- Specific genetic variations affecting drug metabolism (UGT1A1 alterations)
- Uncontrolled or severe liver disease
- Active alcohol use disorder
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
3
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
4
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
5
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
6
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
7
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
8
UC San Diego Medical Center - Hillcrest
San Diego, California, United States, 92103
Actively Recruiting
9
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
10
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Maryland, United States, 20892
Actively Recruiting
11
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Active, Not Recruiting
12
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
13
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
14
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
15
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
16
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
17
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
18
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
19
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
20
University of Washington Medical Center - Montlake
Seattle, Washington, United States, 98195
Actively Recruiting
21
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States, 53718
Actively Recruiting
22
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
23
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Active, Not Recruiting
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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