Study of NK012 and Carboplatin in Solid Tumors With Dose Expansion in Triple Negative Breast Cancer

Inclusion Criteria

• •1. Histologically or cytologically confirmed diagnosis of advanced solid tumor for which no efficacious therapy exists, or for which a camptothecin-based regimen would be appropriate.
• •2. For the dose expansion at the MTD/RD only:
• •1. Patients must have triple-negative breast cancer with locally advanced disease for which there is no surgical option, or stage IV disease. Triple-negative breast cancer is defined as HER2-negative, ER-negative, and PR-negative as follows:
• •For HER2- negative (must meet one of the following 3):
• •( i) FISH negative (ratio \<2.2); or ( ii) IHC 0 or 1+; or (iii) IHC 2+ or 3+ and FISH negative (ratio \<2.2) For ER negative and PR negative: ≤ 10% tumor staining by IHC
• •2. No less than one and no more than two prior chemotherapy regimens for advanced or metastatic breast cancer.
• •3. Patients must have measurable disease by RECIST (version 1.1).
• •3. Patients must have recovered from all acute adverse effects of prior therapies, excluding alopecia.
• •4. For patients enrolled in the dose escalation phase, no more than 4 prior cytotoxic regimens in the metastatic setting.
• •5. Prior irradiation to no more than 25% of the bone marrow.
• •6. ECOG performance status of 0 or 1.
• •7. Life expectancy of at least 12 weeks.
• •8. Patients are at least 18 years of age.
• •9. Adequate bone marrow function defined as ANC ≥ 1500/mm\^3 and platelet count ≥ 100,000/mm\^3.
• •10. AST and ALT ≤ 3.0 x ULN (5X ULN if documented liver metastases) and total bilirubin ≤ 1.5 x ULN.
• •11. Serum creatinine \< 1.5 x ULN, or creatinine clearance \> 60 mL/min by Cockcroft-Gault formula\* for patients with serum creatinine \> 1.5x ULN.
• •\* Cockcroft-Gault formula for creatinine clearance (CrCl): Males: CrCl (ml/min) = (140 - age) x wt (kg) / (serum creatinine x 72) Females: Multiply the above result by 0.85
• •12. Able to understand and show willingness to sign a written informed consent document.