None listed
Conditions
Interventions
Drug : - Clinical trial drug (nesuparib capsule 25 mg, 150 mg)
nesuparib capsule 25 mg, 150 mg is a solid oral dosage form in capsule form. nesuparib capsule 25 mg contains 25 mg of raw drug substanc
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 3. Registration of subjects receiving treatment 3.1 Inclusion criteria 1. Subjects confirmed to have increased expression of relevant genes and proteins through screening in the master protocol 2. Pathologically or cytologically confirmed cancer 3. 19 years of age or older on the date of signing the consent form 4. Patients with ECOG performance status 0-1 5. Patients with an expected survival period of > 8 weeks. 6. Subjects with adequate organ function as defined in the following items; 1) Hemoglobin =10.0 g/dL 2) Absolute neutrophil count (ANC) = 1.5 x 109/L (= 1,500 per mm3) 3) Platelet count = 100 x 109/L (= 100,000 per mm3) 4) Serum bilirubin = 1.5 x institutional upper limit of normal (ULN). (Gilbert’s syndrome is an exception). 5) AST (SGOT)/ALT (SGPT) = 2.5 x institutional UNL (= 5x ULN in the presence of liver metastases) 6) 24-h urine creatinine clearance or eGFR > 40 mL/min 7. For women, negative pregnancy test or non-fertile women defined as follows: - Menopause (cessation of menstruation for 1 year or more without other medical reasons) based on medical history - Patients who underwent hysterectomy or bilateral tubal ligation or bilateral oophorectomy 8. Women of fertile potential must agree to follow effective contraception (Appendix 1) during the trial period and for at least 14 months and 8 days after the last dose of the trial drug, and must have a negative result in a urine or serum pregnancy test performed within 14 days prior to the first dose of the trial drug. 9. Intolerance to all available standard therapies or progressive disease 10. Solid tumors with HRD findings in genomic analysis (HRDetect score = 0.7) 11. Presence of measurable lesions on RECIST (not applicable in phase 1b combination therapy)
Exclusion criteria
Exclusion criteria: 3.2 Exclusion criteria 1. As of the first day of administration of this clinical trial drug (Cycle 1 Day 1), the last day of systemic anticancer treatment (including immunotherapy and small molecule targeted therapy) is less than 14 days, the last day of monoclonal antibody administration is less than 28 days, or the last day of nitrosourea/mitomycin C administration is less than 42 days (consent can be obtained and screening tests can be performed even if the period has not passed) 2. Conditions, treatments, or history of the subjects that the researcher determines will make it difficult to evaluate the clinical trial results. 3. Uncontrolled active infection, symptomatic heart failure, uncontrolled hypertension/unstable angina/arrhythmia, active bleeding tendency, active hepatitis, mental illness or social situation that may interfere with written consent 4. Patients with a history of leptomeningeal metastasis. 5. Patients with uncontrolled brain metastases or spinal cord compression (patients whose symptoms are stable after discontinuation of anticonvulsants at least 14 days before administration of the clinical trial drug may be enrolled) 6. Uncontrolled seizure 7. Pregnant or potentially pregnant women, breastfeeding women, men or women of childbearing potential who are unwilling to use adequate contraception for 14 months and 8 days after the end of the clinical trial 8. Dialysis patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Parameters | — |
Countries
Korea, Republic of
Contacts
Public ContactHye sun Youn
National Cancer Center
Outcome results
None listed