Table 3.
Selection of ongoing HER2-targeting studies in advanced gastric cancer.
| Study | Phase | Drug | Therapy Line | Remark | Status | Primary Endpoint |
|---|---|---|---|---|---|---|
| Monoclonal Antibodies | ||||||
|
NCT05555251 CONTRAST |
Ib/II | BI-1607 | >2 L | Fc-Engineered mAB against CD32b + T |
recruiting | safety, dose escalation |
| NCT04908813 | II | HLX22 | 1 L | + T + CAPOX vs. placebo |
recruiting | PFS, ORR |
| Bispecific Antibodies | ||||||
| NCT03929666 | II | Zanidatamab | 1 L | + CTx | recruiting | safety, ORR |
|
NCT05152147 HERIZON-GEA-01 |
III | Zanidatamab | 1 L | + CAPOX/ FP ± Tislelizumab vs. T + CAPOX/ FP |
recruiting | PFS, OS |
| NCT05427383 | II/III | KN026 | ≥2 L | + Pacli/ Docetaxel/ Irinotecan vs. placebo |
recruiting | PFS, OS |
| NCT05190445 | II | Cinrebafusp alfa | ≥2 L | ± Ram + Pacli ± Tucatinib |
active | ORR |
| Tyrosine kinase inhibitors (TKIs) | ||||||
|
NCT04499924 MOUNTAINEER02 |
II/III | Tucatinib | ≥2 L | ± T + Ram + Pacli vs. placebo + Ram + Pacli |
active | OS |
| NCT04430738 | Ib/II | Tucatinib | 1 L | + T ± FOLFOX/CAPOX, ± Pem |
recruiting | dose escalation |
| NCT06109467 | II | Neratinib | 1 L | + T + Pem + FOLFOX |
recruiting | ORR |
| Antibody–drug conjugate (ADC) | ||||||
|
NCT04379596 Destiny-Gastric03 |
Ib/II | Trastuzumab Deruxtecan | 1 L | ± CTx ± ICI |
recruiting | dose escalation (I), ORR (II) |
|
NCT04704934 Destiny-Gastric04 |
III | Trastuzumab Deruxtecan | 2 L | vs. Ram + Pacli | recruiting | OS |
| NCT06078982 | I | Disitamab Vedotin (RC48) | ≥2 L | + Toripalimab HER2-low |
recruiting | ORR |
| NCT05980481 | II/III | Disitamab Vedotin (RC48) | 1 L | + Toripalimab ± T ± CAPOX |
recruiting | safety |
| NCT05141747 | II | MRG002 | ≥2 L | HER2-positive and low | recruiting | ORR |
| NCT04492488 | I/II | MRG002 | last line | recruiting | dose escalation, ORR | |
| NCT05671822 | Ib/II | SHR-A1811 (Trastuzumab Rezetecan) | ≥2 L | ± ICI ± X ± CAPOX |
recruiting | dose escalation, ORR |
| NCT03821233 | I | Zanidatamab Zovodotin (ZW49) | last line | HER2-positive advanced solid tumors | active | safety, tolerability |
| NCT03255070 | I | ARX788 | last line | HER2-positive advanced solid tumors | active | safety, ORR |
| Immune modulation | ||||||
|
NCT03740256 VISTA |
I | HER2 CAR plus CAdVEC (oncolytic adenovirus) | last line | basket trial HER2-positive solid tumors | recruiting | safety |
| NCT04511871 | I | HER2 CAR | last line | HER2-positive solid tumors | recruiting | dose escalation |
| NCT04660929 | I | HER2 CAR macrophage | last line | HER2-positive solid tumors ± Pem |
recruiting | safety |
|
NCT04727151 TACTIC-2 |
I/II | TAC T cells (TAC01-HER2) |
≥2 L | HER2-positive solid tumors ± Pem |
recruiting | safety (I) ORR, PFS, OS (II) |
| NCT05315830 | I | HER2 tumor vaccine | further lines | ± P/ F/ X | recruiting | safety |
|
NCT05311176 nextHERIZON |
II | IMU-131 (HER-Vaxx) | ≥2 L | ± Ram + Pacli ± Pem |
recruiting | safety, ORR |
| NCT05207722 | I/II | CYNK-101 | 1 L | + Pem + T + CTx |
active | dose escalation |
|
NCT05002127 ASPEN-06 |
II/III | Evorpacept (ALX148) | ≥2 L | + T + Ram + Pacli vs. Ram + Pacli ± T |
recruiting | ORR (II) OS (III) |
| Divers | ||||||
| NCT04467515 | I/II | CAM-H2 | ≥2 L | HER2-directed radioligand | recruiting | ORR |
CTx = chemotherapy, F = 5-fluorouracil, ICI= immune checkpoint inhibition, P = cisplatin, Pacli = paclitaxel, Pem = pembrolizumab, Ram = ramucirumab, T = trastuzumab, X = capecitabin.