Her2-BATS and Pembrolizumab in Metastatic Breast Cancer

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT03272334
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HER2 BATs with Pembrolizumab — DRUG
    8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab

Study Details

This proposal uses HER2Bi armed activated T-cells (HER2 BATs) to target breast cancer in combination with pembrolizumab (PBZ) in women with metastatic breast cancer (MBC). Phase I will determine a safe dose of the combination of PBZ and HER2 BATs in 3 to 18 patients. In the phase II portion, an additional 12 patients will be treated at the selected dose to further evaluate the safety and preliminary efficacy. Study treatment includes a combination of 8 infusions of BATs using a previously established schedule and one to three infusions of PBZ (200 mg per dose). PBZ will be added to 8 infusions of BATs in 3 schedules: #1) after the 8th BATs infusion; #2) after the 4th and 8th BATs infusions; and then, #3) before the 1st and after the 4th and 8th BATs infusions.

Key Dates

Start date
Dec 29, 2017
Status verified
Feb 2026
Primary completion
Nov 30, 2024
Completion
Jan 31, 2031

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Schedule #1
    At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 1 infusion of Pembrolizumab in week #7. No interventions within weeks #3 and 4.
  • Experimental: Schedule #2
    At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 2 infusions of Pembrolizumab; the first given within weeks #3 - 4 and the second in week #7.
  • Experimental: Schedule #3
    At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7.

Primary Outcome Measure

Dose Limiting Toxicities (Escalation and Expansion Cohorts) [ Time Frame: From start of study treatment until 3 weeks after last dose of study treatment, assessed over about 10 weeks. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ashley DoniheeCharlottesvilleVirginia22908-

Related coverage on Hipa.ai

Find similar trials in Charlottesville, VA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Ashley Donihee· Charlottesville, VA

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