HER2- and HER3-primed dendritic cells / H. Lee Moffitt Cancer Center and Research Institute - LARVOL DELTA

Results of the Dose-Expansion Cohort of a Phase 1 Trial of Intratumoral HER2- and HER3-Primed Dendritic Cells Injections for the Treatment of Early-Stage TNBC and HR Low Positive Breast Cancer.DecipHER trial (SABCS 2025) - P1 | "PCR was observed in 77.8% of the pts and it was observed at higher frequency among pts with T2 vs T3 tumors (92.3 vs 50%).Conclusion : Intratumoral DCs in combination with standard neoadjuvant chemotherapy and pembrolizumab showed preliminary efficacy and were well tolerated in pts with high-risk HR 20%, HER2-negative BC. This trial is ongoing to further assess the event-free survival of this novel treatment; correlative analyses will follow. The study is open at H. Lee Moffitt Cancer Center."

IO biomarker • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ERBB3 • HER-2 • PD-L1

DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting ➔ Recruiting | Trial completion date: Oct 2025 ➔ Oct 2026 | Trial primary completion date: Oct 2024 ➔ Oct 2026

Enrollment open • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ERBB3 • HER-2

DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Apr 2025 ➔ Aug 2025

Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Suspended ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer (clinicaltrials.gov) - P1 | N=30 | Suspended | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Suspended

Trial suspension • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ERBB3 • HER-2