Table 1 HER2-directed immunotherapy trials under development.
Compound | Classification | Study phase | Patient population | HER2 1-2+, non-amplified allowed, y/n | Lines of therapy, no. | Study population (n), no. | NCT ID |
---|---|---|---|---|---|---|---|
HER2-directed mab | |||||||
MCLA-128 | HER2/HER2 mAb | 2 | HER2+ LAD or MBC | Yes | >1 | 120 | 03321981 |
GBR 1302 | CD3 bispecific mAb | 1/2 | HER2+ LAD or MBC | No | >1 | 158 | 03983395 |
HER2-directed ADC | |||||||
RC48 | HER2 ADC | 1b/2 | HER2+ LAD or MBC | No | >1 | 165 | 03052634 |
DS-8201a | HER2 ADC | 3 | HER2+ LAD or MBC | No | >1 | 600 | 03523585 |
DS-8201a | HER2 ADC | 3 | HER2+ LAD or MBC | No | >1 | 500 | 03529110 |
DS-8201a | HER2 ADC | 3 | HER2+ LAD or MBC | Yes | >1 | 540 | 03734029 |
RC48 | HER2 ADC | 1b/2 | HER2+ LAD or MBC | No | >1 | 165 | 03052634 |
FS-1502 | HER2 ADC | 1 | HER2+ LAD or MBC | Yes | >1 | 92 | 03944499 |
SYD985 | HER2 ADC | 2 | HER2+ LAD or MBC | No | >2 | 345 | 03262935 |
ARX788 | HER2 ADC | 1 | HER2+ LAD or MBC | Yes | >1 | 60 | 03255070 |
PD-1/PD-L1 immune checkpoint inhibitors | |||||||
Pembrolizumab | PD-1 mAb | 1b | HER2+ LAD or MBC | No | >1 | 27 | 03032107 |
Pembrolizuab | PD-1 mAb | 2 | HER2+ stage I-III | No | 0 | 174 | 03747120 |
Atezolizumab | PD-L1 mAb | 1b | HER2+ LAD or MBC | Yes | >1 | 98 | 02605915 |
Atezolizumab | PD-L1 mAb | 3 | HER2+ LAD or MBC | No | >1 | 6000 | 03199885 |
Atezolizumab | PD-L1 mAb | 2a | HER2+ LAD or MBC | No | 0 | 50 | 03125928 |
Atezolizumab | PD-L1 mAb | 3 | HER2+ stage I-III | No | 0 | 453 | 03726879 |
Atezolizumab | PD-L1 mAb | 2 | HER2+ MBC with CNS involvement | No | – | 33 | 03417544 |
KN035 | PD-L1 mAb | 2 | HER2+ LAD or MBC | NR | >1 | 59 | 04034823 |
Cytokine directed therapies | |||||||
IFN-γ | Th1 cytokine | 2 | HER2+ stage I-III | No | N/A | 43 | 03112590 |
Tocilizumab | IL-6 receptor inhibitor mAb | 1 | HER2+ LAD or MBC | No | >1 | 20 | 03135171 |
Utomilumab | Receptor co-stimulatory of TNF mAb | 1b | HER2+ LAD or MBC | No | >1 | 79 | 03364348 |
Utomilumab | Receptor co-stimulatory of TNF mAb | 2 | HER2+ LAD or MBC | No | >1 | 100 | 03414658 |
CAR-T-cell | |||||||
CAR T-cell | Anti-HER2 CAR T-cell NOS | 1/2 | HER2+ LAD or MBC | NR | >1 | 60 | 02713984 |