Active trials testing immune optimized anti-HER2 treatments for HER2+ BC

Strategy TestedStudyPhaseSettingTreatmentN. Patients
Immune-optimized anti-HER2 antibodiesSOPHIA NCT02492711IIIHER2+ mBC progressed on HER2-targeted treatmentRandomized:-Chemotherapy+ Margetuximab-Chemotherapy+ Trastuzumab530 (active, not recruiting)
Bispecific antibodiesNCT02829372IProgressive HER2+ Solid TumorsGBR1302 (CD3/HER2 bispecific mAb)60 (recruiting)
VaccinesNCT03387553IDuring neoadjuvant treatment (HER2+ BC)HER-2 Pulsed Dendritic cell vaccine24 (recruiting)
NCT02061423IPost-neoadjuvant residual disease HER-2+ BCHER-2 Pulsed Dendritic cell vaccine7 (active, not recruiting)
NCT02063724IAdjuvant (High Risk HER2+ BC)HER-2 Pulsed Dendritic cell vaccine15 (active, not recruiting)
NCT00436254IStage III-IV HER2+ BC or OCpNGVL3-hICD vaccine (plasmid-based DNA vaccine) + GM-CSF66 (active, not recruiting)
NCT01730118ISolid tumors with 1–3+ HER2/Neu ExpressionAdenoviral Transduced Autologous HER2/Neu Dendritic Cell Vaccine65 (recruiting)
NCT01376505IAdvanced solid tumorsSynthetic peptides of HER-2 comprising B cell epitopes with a Promiscuous T cell epitope of Measles Virus36 (recruiting)
NCT01355393I/IIStage II-IV HER2+ BCHER-2/neu peptide vaccine + rintatolimod and/or GM-CSF50 (active, not recruiting)
NCT00194714I/IIStage IV HLA-A2+ HER2+ BC or OC receiving TrastuzumabHER2 cytotoxic T-cell peptide-based vaccine20 (enrolling by invitation)
NCT01922921I/IIStage IV HER2+ BC receiving HER2-targeted mAbRandomized:-HER2 ICD peptide-based vaccine+polysaccharide-K-HER2 ICD peptide-based vaccine+Placebo31 (active, not recruiting)
NCT00343109IIHER2+ stage IIIB- IV BC receiving trastuzumabHER-2/neu intracellular domain peptide-based vaccine mixed with GM-CSF38(active, not recruiting)
NCT00266110IIHLA-A0201+ HER2+ mBCDendritic cell Vaccine + GM-CSF + trastuzumab + vinorelbine17(active, not recruiting)
NCT03384914IIAdjuvant HER2+ BCRandomized:-Dendritic Cell (DC1) Vaccine-pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC)110 (recruiting)
NCT00640861NATreated Stage II/III MUC1+ HLA-A2+ BCRandomized: combinations of MUC1/HER-2/Neu Peptide Based Immunotherapeutic Vaccines45 (active, not recruitng)
NCT02297698IIAdjuvant (High Risk HER2+ BC)Randomized:Trastuzumab/GM-CSF +/− nelipepimut-S100 (recruiting)
Immune-stimulating agents concomitantly with trastuzumabNCT03571633IIOperable HER2+ BCRandomized:Paclitaxel/trastuzumab +/− Pegfilgrastim90 (not yet recruiting)
NCT03112590I/IIHER2+ BCIFN-γ + Paclitaxel+Pertuzumab+Trastuzumab48 (recruiting)
Cellular immunotherapyNCT02843126I/IIRecurrent HER2 + BCRandomized:Trastuzumab +/− NK immunotherapy30 (recruiting)
NCT02713984I/IIRelapsed or refractory HER2+ solid tumorsanti-HER2 CAR-modified T cells60 (recruiting)

BC breast cancer, CAR chimeric antigen receptor, GM-CSF granulocyte-macrophage colony-stimulating factor, HLA human leukocyte antigen, ICD intracellular domain, IFN- γ interferon gamma, mAb monoclonal antibody, mBC metastatic breast cancer, MUC1 mucin1, N number, NA not available, NK natural killer, OC ovarian cancer