Phase I Study of EOC202 Plus Paclitaxel in Chinese Patients With Metastatic Breast Cancer

This study is an open label, single arm, dose-escalation phase I study, performed in ambulatory setting with patients receiving first line chemotherapy for metastatic breast carcinoma. The standard 6 cycles of paclitaxel (80 mg/m² at D1, D8 and D15 of every 4-week cycle) will be given to subjects. Twenty mg i.v. dexamethasone will be given in the first cycle before each paclitaxel infusion. Corticosteroids will not be administered after the first chemotherapy cycle if the first 3 i.v. infusions of paclitaxel have been well tolerated. Two EOC202 dose levels, 6 mg and 30 mg will be given to subjects during the cycle and be evaluated in successive cohorts of patients. For each dose level, 3 patients will be administered one subcutaneous dose every 2 weeks for a total of 24 weeks (12 injections in total), separated by 13-day administration-free intervals. The 30 mg dose will be dosed to 3 new patients if the 6 mg dose has been deemed safe and well tolerated. Cohort A - 3 patients at the 6 mg dose - will receive EOC202 administration in seriatim separated by four-week intervals for DLT observation. If safety/tolerability are acceptable at the end of the DLT observation periods, the study will proceed to the next dose. Cohort B - 3 patients at the 30 mg dose - will receive EOC202 administration in seriatim separated by four-week intervals for DLT observation. If safety/tolerability are acceptable at the end of the 4-week observation periods, the study will proceed to the next phase. Cohort C will comprise of additional 6 patients as the PK dose expansion group based on the recommended dose for expansion (RDE). The study procedure is the same with the corresponding dose group. All patients will participate in a pharmacokinetic (PK) and pharmacodynamic (PD) study which involves additional blood samples.