4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 79
Summary
- Conditions
- HER2 Positive Breast Carcinoma
- Recurrent Breast Carcinoma
- Stage III Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Stage IIIC Breast Cancer
- Stage IV Breast Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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...
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.
Tracking Information
- NCT #
- NCT03364348
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: George Sledge, MD Stanford Cancer Institute
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