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

NCT04727151 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-06-08

Study results available
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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 as a monotherapy, and in combination with pembrolizumab, in subjects with HER2 positive gastric and gastroesophageal adenocarcinoma.

Conditions

  • HER2 Positive Gastric Cancer
  • Metastatic HER2 Positive Gastroesophageal Junction Cancer

Interventions

BIOLOGICAL

TAC01-HER2

TAC01-HER2 and: * fludarabine and cyclophosphamide, or * clofarabine and cyclophosphamide, or * bendamustine, or * cyclophosphamide

BIOLOGICAL

TAC01-HER2 plus pembrolizumab

TAC01-HER2 plus pembrolizumab and: * fludarabine and cyclophosphamide, or * clofarabine and cyclophosphamide, or * bendamustine, or * cyclophosphamide

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2023-12-17
Completion
2024-03-25
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04727151 on ClinicalTrials.gov