Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
George W. Sledge Jr.
With
PRIMARY OBJECTIVE: Estimate the maximum tolerated dose (MTD) and determine the recommended dose (RP2D) of utomilumab in combination with ado-rastuzumab emtansine (T-DM1) or trastuzumab in subjects with HER2-positive advanced breast cancer. SECONDARY OBJECTIVES: * Determine the objective tumor response (ORR) * Determine the time to tumor response (TTR) * Determine the duration of response (DR) * Determine progression free survival (PFS) * Assess the safety and tolerability of utomilumab in combination with ado-trastuzumab emtansine or trastuzumab OUTLINE: Patients are randomized to 1 of 2 cohorts. COHORT 1: Dose 1: Utomilumab 20 mg IV + ado-trastuzumab emtansine (T-DM1) 3.6 mg/kg IV every 3 weeks. Dose 2: Dose Level 2 - Utomilumab 100 mg IV + ado-trastuzumab emtansine 3.6 mg/kg IV every 3 weeks COHORT 2: Dose 1: Utomilumab 20 mg IV + trastuzumab 6 mg/kg IV every 3 weeks. Dose Level 2 - Utomilumab 100 mg IV + trastuzumab 6 mg/kg IV every 3 weeks.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
