Table 3 The FDA-approved and clinical-stage multi-specific antibodies
From: Emerging new therapeutic antibody derivatives for cancer treatment
Name | Target | Format | Indication(s) | Status | ClinicalTrials.gov identifier | Reference |
|---|---|---|---|---|---|---|
Blinatumomab/Blincyto/MT103/MEDI-538/AMG103 | CD3, CD19 | BiTE | Hematological malignancies | Marketed | NCT01466179 NCT02013167 | |
AFM11 | CD3, CD19 | Tandem diabody (TandAb) | Relapsed B cell non-Hodgkin lymphoma | Terminated | NCT02848911 | |
AMG562 | CD3, CD19 | HLE-BiTE | Hematological malignancies | Phase I | NCT03571828 | |
REGN1979 | CD3, CD20 | Common light chain | Non-Hodgkin lymphoma | Phase II | NCT03888105 | |
Glofitamab/RO7082859 | CD3, CD20 | Fab-Fc (IgG1) × Fab-Fab-Fc (IgG1), CrossMab | Non-Hodgkin lymphoma | Phase I | NCT03075696 | |
Plamotamab/XmAb13676 | CD3, CD20 | Fab-scFv-Fc | Non-Hodgkin lymphoma | Phase I | NCT02924402 | |
Mosunetuzumab/RG7828/RO7030816 | CD3, CD20 | Knob-into-hole (KiH) | B cell lymphoma | Phase I | NCT04313608 | |
GEN3013 | CD3, CD20 | DuoBody | B cell lymphoma | Phase I | NCT03625037 | |
AMG673 | CD3, CD33 | HLE-BiTE | Relapsed/refractory acute myeloid leukemia | Phase I | NCT03224819 | |
AMV-564 | CD3, CD33 | Tandem diabody (TandAb) | Acute myeloid leukemia | Phase I completed | NCT03144245 | |
ISB 1342 | CD3, CD38 | Fab-Fc (IgG1) × scFv-Fc (IgG1) | Multiple myeloma | Phase I | NCT03309111 | |
JNJ-63709178 | CD3, CD123 | DuoBody | Relapsed or refractory acute myeloid leukemia (AML) | Phase I completed | NCT02715011 | |
SAR440234 | CD3, CD123 | CODV-Fab-TL1 | Leukemia | Terminated | NCT03594955 | |
Vibecotamab/Xmab14045 | CD3, CD123 | Fab-scFv-Fc | Hematologic malignancies | Terminated | NCT02730312 | |
AMG420/BI 836909 | CD3, BCMA | BiTE | Relapsed and/or refractory multiple myeloma | Phase I | NCT03836053 | |
CC-93269/EM801 | CD3, BCMA | CrossMab, KiH | Relapsed and/or refractory multiple myeloma | Phase I | NCT03486067 | |
Teclistamab/JNJ-64007957 | CD3, BCMA | Duobody | Hematological malignancies | Phase II | NCT04557098 | |
PF-06863135 | CD3, BCMA | DuoBody | Multiple myeloma | Phase II | NCT04649359 | |
REGN5458 | CD3, BCMA | Fab-Fc-Fab | Multiple myeloma | Phase I/II | NCT03761108 | |
Catumaxomab/removab | CD3, EpCAM | TrioMab | Malignant ascites | Withdrawn from the market | / | |
Marketed | CD3, gp100 | ImmTAC | Uveal melanoma | Phase III | NCT03070392 | |
RG6194/BTRC4017A | CD3, HER2 | Undisclosed | Solid tumors | Phase I | NCT03448042 | |
M802 | CD3, HER2 | YBODY | HER2-positive solid tumors | Phase I | NCT04501770 | |
GBR1302 | CD3, HER2 | Fab-scFv-Fc | Breast cancer | Terminated | NCT03983395 | |
Cibisatamab/RG7802/RO6958688 | CD3, CEA | 2:1 CrossMab | Colorectal cancer | Phase I | NCT03866239 | |
AMG211 | CD3, CEA | BiTE | Advanced gastrointestinal cancer | Terminated | NCT02291614 | |
AMG160 | CD3, PSMA | HLE-BiTE | Prostate cancer | Phase I | NCT03792841 | |
MOR209/ES414 | CD3, PSMA | scFv-Fc (IgG1)-scFv | Prostate cancer | Phase I completed (discontinued) | NCT02262910 | |
Pasotuxizumab/BAY2010112 | CD3, PSMA | BiTE | Prostate cancer | Phase I completed | NCT01723475 | |
REGN5678 | CD28, PSMA | Fab-Fc (IgG4)-Fab | Prostate cancer | Phase I/II | NCT03972657 | |
FS120 | OX40/4–1BB | Tetravalent mAb2 | Advanced malignancies | Phase I | NCT04648202 | |
PRS-343 | HER2/4–1BB | Anticalin-mAb | HER2-positive solid tumors | Phase I | NCT03330561 | |
AFM13 | CD16A, CD30 | Tandem diabody (TandAb) | Lymphoma | Phase I/II | NCT03192202, NCT04101331 | |
AFM24 | CD16A, EGFR | Tandem diabody (TandAb) | Advanced solid tumor | Phase I | NCT04259450 | |
GTB-3550, OXS-35504 | CD16, CD33, IL-15 | Tri-specific killer engager (TriKE) | Hematological malignancies | Phase I/II | NCT03214666 | |
MEDI5752 | PD-1, CTLA-4 | Common light chain | Advanced renal cell carcinoma, selected advanced solid tumors | Phase I | NCT04522323 | |
AK104 | PD-1, CTLA-4 | Undisclosed | Advanced solid tumors | Phase I/II | NCT04172454 | |
XmAb20717 | PD-1, CTLA-4 | Fab-scFv-Fc | Advanced solid tumors | Phase I | NCT03517488 | |
MGD019 | PD-1, CTLA-4 | DART-Fc | Advanced solid tumors | Phase I | NCT03761017 | |
MGD013 | PD-1, LAG-3 | Tetravalent DART | Solid and hematological malignancies | Phase I | NCT03219268 | |
RO7121661, RG7769 | PD-1, TIM3 | CrossMab, KiH | Solid tumors | Phase I | NCT03708328 | |
KN046 | PD-L1, CTLA-4 | Common light chain | Advanced solid tumors (triple-negative breast cancer, squamous non-small cell lung cancer, thymic carcinoma), lymphoma | Phase I | NCT03872791, NCT04474119, NCT04469725, NCT03733951 | |
FS118 | PD-L1, LAG-3 | Tetravalent mAb2 | Advanced malignancies | Phase I | NCT03440437 | |
LY3415244 | PD-L1, TIM3 | Undisclosed | Solid tumor | Phase I terminated | NCT03752177 | |
IBI318/LY3434172 | PD-1, PD-L1 | Undisclosed | Advanced malignancy | Phase I/II | NCT03875157 | |
IBI315 | PD-1, HER2 | Undisclosed | Advanced solid tumor | Phase I | NCT04162327 | |
AK112 | PD-1, VEGF | Tetrabody | Advanced solid tumor malignancies | Phase I | NCT04047290 | |
IBI319 | PD-1, 4–1BB | Knob-into-hole | Advanced malignant tumors | Phase I | NCT04708210 | |
FS222 | PD-L1, 4–1BB | mAb2 | Advanced cancer, metastatic cancer | Phase I | NCT04740424 | |
MCLA-145 | PD-L1, 4–1BB | Common light chain | Advanced or metastatic malignancies | Phase I | NCT03922204 | |
ATOR 1015 | CTLA4, OX40 | mAb × Ligand | Solid tumors | Phase I completed | NCT03782467 | |
XmAb23104 | PD-1, ICOS | Xmab | Solid malignancies | Phase I | NCT03752398 | |
TG-1801/NI-1701 | CD47, CD19 | κλ body | B cell lymphoma | Phase I | NCT03804996 | |
IMM0306 | CD47, CD20 | Fab × Ligand-Fc (IgG1) | Non-Hodgkin lymphoma | Phase I | CTR20192612 | |
IBI322 | CD47, PD-L1 | Undisclosed | Advanced malignancies | Phase I | NCT04338659, NCT04328831 | |
HX009 | CD47, PD-1 | Undisclosed | Advanced solid tumor | Phase I | NCT04097769 | |
JNJ-61186372/Amivantamab | EGFR, MET | Duobody | Non-small cell lung cancer | Marketed | NCT02609776 | |
MCLA-158 | EGFR, LGR5 | Common light chain | Advanced solid tumors | Phase I completed | NCT03526835 | |
MCLA-128/Zenocutuzumab | HER2, HER3 | Common light chain | Breast cancer | Phase I/II | NCT03321981 | |
KN026 | HER2, HER2 | Common light chain | HER2-positive solid tumors | Phase I | NCT04521179 | |
MBS301 | HER2, HER2 | KiH | HER2-positive solid tumors | Phase I | NCT03842085 | |
ZW25 | HER2, HER2 | Common light chain | HER2-positive solid tumors | Phase I | NCT02892123 | |
ZW49 | HER2, HER2 ADC | scFv-Fc (IgG1) × Fab-Fc (IgG1), conjugated to auristatin | HER2-positive solid tumors | Phase I | NCT03821233 | |
MM-141 | IGF-1R, HER3 | scFv-IgG | Metastatic pancreatic cancer | Phase II completed | NCT02399137 | |
BI 836880 | ANG2, VEGF | Tandem VHH | Neoplasms | Phase I/II | NCT03972150, NCT03697304 | |
RO5520985/Vanucizumab | ANG2, VEGF | CrossMab | Neoplasms | Phase II terminated | NCT02141295 | |
ABT-165/Dilpacimab | DLL4, VEGF | Dual-variable-domain antibody (DVD-Ig) | Advanced solid tumors | Phase I | NCT01946074 | |
OMP-305B83/Navicixizumab | DLL4, VEGF | Common light chain | Ovarian, peritoneal or fallopian tube cancer | Phase I completed | NCT03030287 | |
RG7386/RO6874813 | FAP, DR5 | 2:2 CrossMab | Solid tumor | Phase I completed | NCT02558140 | |
OXS-1550/DT2219ARL | CD19, CD22 | scFv-scFv toxin | Relapsed or refractory B-lineage leukemia or lymphoma | Phase I/II completed | NCT02370160 |
