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TAC T-cells for the Treatment of HER2-positive Solid Tumors (TACTIC-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04727151
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : December 3, 2021
Sponsor:
Information provided by (Responsible Party):
Triumvira Immunologics, Inc.

Brief 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.


Condition or disease Intervention/treatment Phase
HER2-Positive Solid Tumors Biological: TAC01-HER2 Phase 1 Phase 2

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC T Cells Targeting HER2 in Relapsed or Refractory Solid Tumors
Actual Study Start Date : April 19, 2021
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : February 2025


Arm Intervention/treatment
Experimental: TAC01-HER2
Lymphodepletion followed by TAC01-HER2 as a single IV infusion.
Biological: TAC01-HER2
TAC01-HER2, fludarabine, cyclophosphamide.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 24 Months ]
    Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5 and American Society for Transplantation and Cellular Therapy (ASTCT) 2018 criteria.


Secondary Outcome Measures :
  1. Determine MTD or RP2D [ Time Frame: 28-42 Days Post-Treatment ]
    Assessed by incidence of Dose-Limiting Toxicities.

  2. Determine expansion of TAC01-HER2 [ Time Frame: 24 Months ]
    Assessed by vector copy number.

  3. Determine persistence of TAC01-HER2 [ Time Frame: 24 Months ]
    Assessed by vector copy number.

  4. Evaluate Overall Response Rate (ORR) [ Time Frame: 1, 3, 6, 9, 12, 18 and 24 months ]
    Assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

  5. Evaluate Overall Survival (OS) [ Time Frame: 24 Months ]
    Defined as the time between the date of TAC01-HER2 infusion and death due to any cause.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. A recent tumor sample to confirm HER2-protein expression on tumor cell surface.
  3. Relapsed or refractory disease after at least two prior lines of therapy.

    a. For breast cancer patients, both prior lines of therapy must include HER2 targeted agents.

  4. Measurable disease per RECIST Version 1.1.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Life expectancy of at least 12 weeks.
  7. Adequate organ function.

Exclusion Criteria:

  1. Active inflammatory or neurological disorder, autoimmune disease or infection
  2. Acute cardiovascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04727151


Contacts
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Contact: Nathan Ternus (512) 646-4516 patient.info@triumvira.com

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Brooke Pieke, MS    773-834-9636    cancerclinicaltrials@bsd.uchicago.edu   
Contact: Andrea Fadel, BSN, RN    773-702-4779    cancerclinicaltrials@bsd.uchicago.edu   
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Riemke Bouvier    617-582-8529    Riemke_Bouvier@dfci.harvard.edu   
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Ecaterina Dumbrava, MD    713-792-3934    eeileana@mdanderson.org   
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2C1
Contact: Samuel Saibil, MD    416-946-4501 ext 4831    Sam.Saibil@uhn.ca   
Sponsors and Collaborators
Triumvira Immunologics, Inc.
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Responsible Party: Triumvira Immunologics, Inc.
ClinicalTrials.gov Identifier: NCT04727151    
Other Study ID Numbers: TAC01-HER2-03
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: December 3, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Triumvira Immunologics, Inc.:
HER2-Positive Breast Cancer
HER2-Positive Gastric Cancer
HER2 Protein Overexpression
Solid Tumor
HER2
Additional relevant MeSH terms:
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Neoplasms