TAC T-cells for the Treatment of HER2-positive Solid Tumors

  • STATUS
    Recruiting
  • End date
    Feb 8, 2025
  • participants needed
    70
  • sponsor
    Triumvira Immunologics, Inc.
Updated on 5 December 2021

Summary

TAC01-HER2 is a novel 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). TAC directs T-cells to the targeted antigen (HER2), and once engaged with the target, activates them via the endogenous T cell receptor.

This is an open-label, multicenter Phase 1/2 study that aims to establish safety, Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D), pharmacokinetic profile and efficacy of TAC01-HER2 in subjects with relapsed or refractory solid tumors.

Description

Phase I: Dose escalation in any 3+ HER2-positive solid tumor.

Phase II: Dose expansion cohorts: 3+ HER2-positive breast cancer (a) and other solid tumors (b) 2+HER2-positive solid tumors (c).

Details
Condition HER2 Positive Solid Tumors
Treatment TAC01-HER2
Clinical Study IdentifierNCT04727151
SponsorTriumvira Immunologics, Inc.
Last Modified on5 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years
A recent tumor sample to confirm HER2-protein expression on tumor cell surface
Relapsed or refractory disease after at least two prior lines of therapy
For breast cancer patients, both prior lines of therapy must include HER2 targeted agents
Measurable disease per RECIST Version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of at least 12 weeks
Adequate organ function

Exclusion Criteria

Active inflammatory or neurological disorder, autoimmune disease or infection
Acute cardiovascular disease
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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