NCT05504707: DecipHER

Phase 1 Dose-Escalation, Dose-Expansion Trial of Intratumoral HER2- and HER3-Primed Dendritic Cells Injections for the Treatment of Early-Stage TNBC and ER Low Positive Breast Cancer (DecipHER)

Recruiting now Phase 1 Last updated 3 February 2026

What this trial tests

Phase 1 trial testing HER2 - primed Dendritic cells in Triple Negative Breast Cancer in 30 participants. Currently enrolling.

Timeline

26 August 2022

Primary endpoint
1 October 2026

1 October 2026

Quick facts

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	26 August 2022
Primary completion	1 October 2026
Estimated completion	1 October 2026
Sites	1 location across United States

Drugs / interventions tested

• HER2 - primed Dendritic cells — full drug profile →
• HER3 - primed Dendritic cells — full drug profile →

Conditions studied

• Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →
• HER2-negative Breast Cancer — all drugs for HER2-negative Breast Cancer →

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

18 and older, any sex, with Triple Negative Breast Cancer or HER2-negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Maximum Tolerated Dose (MTD)
  Time frame: 4 weeks after start of treatment
  Maximum Tolerated Dose (MTD) of HER2- and HER3- primed DC1 study vaccines. The MTD will be defined as the highest dose level at which \< 2 of 6 patients experience dose-limiting toxicities (DLTs).

Sponsor's own description

The purpose of the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive breast cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting HER3 for cancer treatment: a new horizon for an old target.
   Uliano J, Corvaja C, Curigliano G, Tarantino P. · · 2023 · cited 48× · PMID 36764093 · DOI 10.1016/j.esmoop.2023.100790
2. Trial watch: anticancer vaccination with dendritic cells.
   Borges F, Laureano RS, Vanmeerbeek I, Sprooten J, et al · · 2024 · cited 18× · PMID 39398476 · DOI 10.1080/2162402x.2024.2412876
3. Intratumoral delivery of immunotherapy to treat breast cancer: current development in clinical and preclinical studies.
   Mantooth SM, Abdou Y, Saez-Ibañez AR, Upadhaya S, et al · · 2024 · cited 13× · PMID 38803496 · DOI 10.3389/fimmu.2024.1385484
4. Overcoming Suppressive Tumor Microenvironment by Vaccines in Solid Tumor.
   Xie YJ, Liu WQ, Li D, Hou JC, et al · · 2023 · cited 13× · PMID 36851271 · DOI 10.3390/vaccines11020394
5. Manufacturing and Financial Evaluation of Peptide-Based Neoantigen Cancer Vaccines for Triple-Negative Breast Cancer in the United Kingdom: Opportunities and Challenges.
   Novakova A, Morris SA, Vaiarelli L, Frank S. · · 2025 · cited 5× · PMID 40006691 · DOI 10.3390/vaccines13020144
6. A Holistic Approach to Hard-to-Treat Cancers: The Future of Immunotherapy for Glioblastoma, Triple Negative Breast Cancer, and Advanced Prostate Cancer.
   Puig-Saenz C, Pearson JRD, Thomas JE, McArdle SEB. · · 2023 · cited 4× · PMID 37626597 · DOI 10.3390/biomedicines11082100
7. The application, safety, and future of <i>ex vivo</i> immune cell therapies and prognosis in different malignancies.
   Einloth KR, Gayfield S, McMaster T, Didier A, et al · · 2023 · cited 2× · PMID 38022382 · DOI 10.34172/bi.2023.27521
8. Outcomes After Intratumoral Delivery of Immunotherapy in Breast Cancer.
   Baumrucker CC, Harris N, Aiello P, Whiting J, et al · · 2026 · PMID 42130226 · DOI 10.1002/jso.70287