TAC01-HER2 for HER2 Positive Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
HER2 Positive Breast CancerTAC01-HER2 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2). The purpose of the trial is to establish the safety, maximum tolerated dose, and efficacy of the therapy in subjects with relapsed or refractory solid tumors.

Eligible Conditions
  • HER2 Positive Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 1, 3, 6, 9, 12, 18 and 24 months

Month 24
Evaluate Overall Response Rate (ORR)
24 Months
Determine expansion of TAC01-HER2
Determine persistence of TAC01-HER2
Evaluate Overall Survival (OS)
Incidence of Treatment-Emergent Adverse Events
28-42 Days Post-Treatment
Determine MTD or RP2D

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

TAC01-HER2
1 of 1

Experimental Treatment

70 Total Participants · 1 Treatment Group

Primary Treatment: TAC01-HER2 · No Placebo Group · Phase 1 & 2

TAC01-HER2
Biological
Experimental Group · 1 Intervention: TAC01-HER2 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1, 3, 6, 9, 12, 18 and 24 months

Who is running the clinical trial?

Triumvira Immunologics, Inc.Lead Sponsor
1 Previous Clinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a recent tumor sample to confirm HER2-protein expression on tumor cell surface.
For breast cancer patients, both prior lines of therapy must include HER2 targeted agents.
You have a measurable disease.\n
You have a performance status of 0 or 1.
You have a normal organ function.
You have relapsed or refractory disease after two or more prior lines of therapy.