Table 2 Ongoing and unpublished clinical trials of HER2-targeted therapy
Drug | Trial/Author Year | Phase Status | Population | Intervention | N |
|---|---|---|---|---|---|
Pertuzumab | EORTC-1203-GITCG/INNOVATION 2019 [48] | II processing | perioperation HER2-positive GC | chemotherapy Chemotherapy + Trastuzumab Chemotherapy + Trastuzumab + Pertuzumab | – |
ZW25 | NCT04276293 | Ib/II processing | First-line HER2-positive BC, GC, GEJ adenocarcinoma | ZW25+ Docetaxel ZW25 + Tislelizumab+ Capecitabine + Oxaliplatin | 80 |
KN026 | KN026-CSP-001 | II/III Recruiting | Second-line and beyond HER2-positive G/GEJ adenocarcinoma | II KN026+ Paclitaxel KN026+ Iirinotecan III KN026+ Paclitaxel + Docetaxel + Irinotecan Placebo + Paclitaxel + Docetaxel + Irinotecan | – |
MM-111 | Crystal Shereen Denlinger 2016 [63] | II terminated | – | – | – |
PRS-343 | NCT05190445 | II Recruiting | Second-line and beyond HER2-positive GC | PRS-343 + Ramucirumab + Paclitaxel PRS-343 + Tucatinib | 80 |
DS-8201 | DESTINY-Gastric03 2020 | Ib/II Recruiting | HER2-overexpressing GC | DS-8201 single-agent or combination chemotherapy | 255 |
DESTINY-Gastric04 | III Recruiting | Second-line and beyond HER2-positive metastatic/unresectable G/GEJ adenocarcinoma | DS-8201 Ramucirumab + Paclitaxel | 490 | |
DESTINY-Gastric02 | II processing | Second-line and beyond HER2-positive metastatic unresectable G/GEJ adenocarcinoma | DS-8201 | 79 | |
Disitamab vedotin | NCT04714190 | III Recruiting | Second-line HER2-positive locally advanced/metastatic GC | Disitamab vedotin Paclitaxel/Irinotecan/Apatinib | 351 |
ARX788 | ACE-Pan Tumor 01 | I Recruiting | Second-line and beyond BC, GC, Other solid tumors | ARX788 | 190 |
XMT-1522 | NCT02952729 | Ib completed | Second-line and beyond HER2-positive advanced BC, GC, NSCLC | XMT-1522 | 120 |
ZW49 | NCT03821233 | I Recruiting | Second-line and beyond HER2 positive BC, GEA, other solid tumors | ZW49 | 174 |
ADCT-502 | NCT03125200 | I terminated | Second-line and beyond HER2-positive advanced solid tumors | ADCT-502 | 21 |
GQ1001 | NCT04450732 | I Recruiting | Second-line and beyond HER2 positive BC, GC, other solid tumors | GQ1001 | 27 |
MRG002 | NCT04492488 | I/II Recruiting | Second-line and beyond HER2-positive advanced GC, GEJ adenocarcinoma, other solid tumors | MRG002 | 129 |
CTR20181778 2020 | I processing | HER2-positive locally advanced/metastatic solid tumors | MRG002 | dose escalation 24 dose expansion 50 | |
Tucatinib | MOUNTAINEER-02/NCT04499924 2021 | II/III Recruiting | Second-line and beyond Locally advanced unresectable or metastatic HER2-positive G/GEJ adenocarcinoma | Tucatinib + Trastuzumab + Ramucirumab + Paclitaxel | 578 |
NCT04430738 | Ib/II Recruiting | Second-line and beyond HER2-positive gastrointestinal cancer | Tucatinib + Trastuzumab + FOLFOX | 120 | |
NCT05190445 | II Recruiting | Third-line and beyond HER2+ G/GEJ adenocarcinoma | PRS-343 + Ramucirumab + Paclitaxel PRS-343 + Tucatinib | 80 | |
NCT05382364 | I Approved | Second-line and beyond HER2+ advanced BC, GC, GEJ cancer, colorectal cancer in China | Tucatinib | 25 | |
Pyrotinib | NCT02378389 | I completed | Second-line and beyond HER2-positive advanced GC | Pyrotinib/Pyrotinib + Docetaxel | 28 |
NCT03480256 | Id completed | Second-line and beyond HER2-positive advanced GC | SHR6390+ Pyrotinib | 40 | |
Afatinib | NCT02501603 2015 | II processing | Second-line HER2-positive G/GEJ adenocarcinoma | Afatinib + Paclitaxel | 72 |
NCT01522768 | II processing | Second-line and beyond HER2-positive advanced GEA | Afatinib + Paclitaxel | 42 | |
Neratinib | NCT05274048 | I Approved | Second-line and beyond HER2-positive GC | Neratinib +DS-8201 | 18 |