OncoMatch/Clinical Trials/NCT05687110
Studying the Safety and Determining the Optimal Dose of Novobiocin in Patients With Tumors That Have Alterations in DNA Repair Genes
Is NCT05687110 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Novobiocin Sodium for metastatic malignant solid neoplasm.
Treatment: Novobiocin Sodium — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: BRCA1 pathogenic mutation
known pathogenic mutation in BRCA1
Required: BRCA2 pathogenic mutation
known pathogenic mutation in BRCA2
Required: PALB2 pathogenic mutation
known pathogenic mutation in PALB2
Required: RAD51C pathogenic mutation
known pathogenic mutation in RAD51C
Required: RAD51D pathogenic mutation
known pathogenic mutation in RAD51D
Required: ATM pathogenic mutation
known pathogenic mutation in ATM
Required: BARD1 pathogenic mutation
known pathogenic mutation in BARD1
Required: BLM pathogenic mutation
known pathogenic mutation in BLM
Required: BRIP1 pathogenic mutation
known pathogenic mutation in BRIP1
Required: CDK12 pathogenic mutation
known pathogenic mutation in CDK12
Required: FANCA pathogenic mutation
known pathogenic mutation in FANCA
Required: FANCC pathogenic mutation
known pathogenic mutation in FANCC
Required: FANCD2 pathogenic mutation
known pathogenic mutation in FANCD2
Required: FANCE pathogenic mutation
known pathogenic mutation in FANCE
Required: FANCF pathogenic mutation
known pathogenic mutation in FANCF
Required: FANCM pathogenic mutation
known pathogenic mutation in FANCM
Required: MRE11A pathogenic mutation
known pathogenic mutation in MRE11A
Required: NBN pathogenic mutation
known pathogenic mutation in NBN (NBS1)
Required: RAD50 pathogenic mutation
known pathogenic mutation in RAD50
Required: RAD51B pathogenic mutation
known pathogenic mutation in RAD51B
Excluded: UGT1A1 *28 homozygous or *6 homozygous or compound *28/*6
Patients homozygous for A(TA)7TAA in the promoter region (also known as UGT1A1 *28), homozygous for the G71R allele (also known as UGT1A1*6), or with compound alterations of *28 and *6, are excluded
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: PARP inhibitor — standard-of-care approved cancer types only
Patients with cancers for which PARP inhibitors have been approved as standard-of-care must have received a PARP inhibitor prior to enrollment on this study
Cannot have received: chemotherapy
Exception: within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Cannot have received: radiotherapy
Exception: within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Lab requirements
Blood counts
ANC >= 1,500/mcL; leukocytes >= 3,000/mcL; platelets >= 100,000/mcL
Kidney function
GFR >= 60 mL/min (CKD-EPI)
Liver function
Total bilirubin <= 1.5 × institutional ULN; AST/ALT <= 1.5 × institutional ULN
Cardiac function
QTcF <= 480 ms; NYHA class 2B or better
ANC >= 1,500/mcL; leukocytes >= 3,000/mcL; platelets >= 100,000/mcL; total bilirubin <= 1.5 × institutional ULN; AST/ALT <= 1.5 × institutional ULN; GFR >= 60 mL/min; QTcF <= 480 ms; NYHA class 2B or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Comprehensive Cancer Center · Duarte, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- UC San Diego Moores Cancer Center · La Jolla, California
- Los Angeles General Medical Center · Los Angeles, California
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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