NCT03364348

4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer

A Phase 1B Dose Escalation Trial of Human Anti 4 1BB Agonistic Antibody Utomilumab (PF 05082566) in Combination With Ado Trastuzumab Emtansine or Trastuzumab in Patients With HER2 Postive Advanced Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: George W. Sledge Jr. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies the best dose and side effects of utomilumab (4-1BB agonist monoclonal antibody PF-05082566) with trastuzumab emtansine or trastuzumab in treating patients with HER2-positive breast cancer that has spread to other places in the body. Monoclonal antibodies, such as utomilumab, trastuzumab emtansine, and trastuzumab may interfere with the ability of tumor cells to grow and spread.

Detailed 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 (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.

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

Interventions

Type	Name	Description
DRUG	Utomilumab	Given IV
DRUG	Trastuzumab	Given IV
DRUG	Ado-Trastuzumab Emtansine	Given IV

Timeline

• Start date: 2017-10-30
• Primary completion: 2021-02-15
• Completion: 2022-02-14
• First posted: 2017-12-06
• Last updated: 2022-10-19
• Results posted: 2022-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study