OncoMatch/Clinical Trials/NCT05694715
Combination Therapy in Cancers With Mutations in DNA Repair Genes
Is NCT05694715 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Niraparib and Irinotecan for metastatic solid tumor.
Treatment: Niraparib · Irinotecan — The purpose of this phase 1 clinical trials is to determine whether niraparib (a Poly (ADP-ribose) polymerase inhibitor (PARPi)) can be safely combined with irinotecan with manageable toxicity and reasonable efficacy. Emerging evidence suggest that PARPi is an effective therapeutic strategy in a wider subset of solid tumors that may have defective homologous recombination (HR) or DNA repair gene mutations. BReast CAncer gene (BRCA), partner and localizer of BRCA2 (PALB2), and various other DNA repair germline mutations predispose carriers to cancers of the breast, ovaries, pancreas, prostate and melanoma. A number of preclinical studies have demonstrated that PARP inhibitors can work as chemopotentiators. There is significant interest in this combination, and the recommended phase II dose will be used in the upcoming NCI ComboMatch trial.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: BRCA1 mutation
BRCA1 (based upon archival tumor tissue or germ line testing from any Clinical Laboratory Improvement Amendments (CLIA) approved lab)
Required: BRCA2 mutation
BRCA2 (based upon archival tumor tissue or germ line testing from any Clinical Laboratory Improvement Amendments (CLIA) approved lab)
Required: ATM mutation
ATM (based upon archival tumor tissue or germ line testing from any Clinical Laboratory Improvement Amendments (CLIA) approved lab)
Required: PALB2 mutation
PALB2 (based upon archival tumor tissue or germ line testing from any Clinical Laboratory Improvement Amendments (CLIA) approved lab)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
ANC >= 1.5 x 10^9/L (no growth factors allowed within 14 days of enrollment); Hemoglobin >=10 g/dL (no transfusion allowed within 7 days of enrollment); Platelets >= 100 x 10^9/L
Kidney function
Creatinine <1.5 x ULN, or Estimated GFR >= 50ml/min by Cockcroft-Gault
Liver function
AST and ALT <=2.5 x ULN, or <5 x ULN in patients with known liver metastases or known primary liver tumor(s); Serum total bilirubin <= 1.5 x ULN
Adequate organ function: ANC >= 1.5 X 10^9/L (no growth factors allowed within 14 days of enrollment); Hemoglobin (Hgb) ≥10 g/dL (no transfusion allowed within 7 days of enrollment); Platelets (plt) >= 100 x 10^9/L; AST and ALT <=2.5 x ULN, or <5 x ULN in patients with known liver metastases or known primary liver tumor(s); Serum total bilirubin <= 1.5 x ULN; Creatinine <1.5 x ULN, or Estimated GFR >= 50ml/min by Cockcroft-Gault
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Francisco · San Francisco, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify