Table 1 Bispecific antibodies in clinical trials. Information from ClinicalTrials.gov (https://clinicaltrials.gov)
BsAb | Sponsor | Formats | Targets | Biological function | Clinical trial × identifier | Diseases |
|---|---|---|---|---|---|---|
Catumaxomab | Neovii Biotech | Triomab | EpCAM × CD3 | T cell recruitment, Fc-mediated effector function | Approved in EU | EpCAM-positive tumor, malignant ascites |
| Â | AGO Study Group | Â | Â | Â | Completed phase IIa, NCT00189345 | Platinum refractory epithelial ovarian cancer |
| Â | AIO-Studien-gGmbH | Â | Â | Â | Phase II, NCT01504256 | Gastric adenocarcinomas |
|  | Grupo Español de Investigación en Cáncer de Ovario |  |  |  | Phase II, NCT01246440 | Ovarian cancer |
| Â | Gustave Roussy | Â | Â | Â | Phase IINCT01784900 | Gastric peritoneal carcinomatosis |
Ertumaxomab | Krankenhaus Nordwest | Triomab | HER2 × CD3 | T cell recruitment, Fc-mediated effector function | Phase I/II, NCT01569412 | Her2/Neu-positive advanced solid tumors |
FBTA05 | Technische Universität München | TrioMab | CD20 × CD3 | T cell recruitment | Phase I/II,NCT01138579 | Leukemia |
Blinatumomab | Amgen Research (Munich) GmbH | BiTE | CD3 × CD19 | T cell recruitment | Approved in USA | ALL |
| Â | Amgen Research (Munich) GmbH | Â | Â | Â | Phase I, NCT00274742 | Relapsed NHL |
| Â | Amgen Research (Munich) GmbH | Â | Â | Â | Phase II, NCT01207388 | B cell ALL |
| Â | Amgen Research (Munich) GmbH | Â | Â | Â | Phase II, NCT01209286 | Relapsed/refractory ALL |
| Â | National Cancer Institute | Â | Â | Â | Phase I, NCT02568553 | NHL |
| Â | National Cancer Institute | Â | Â | Â | Phase II, NCT02143414 | Adult B-ALL with t(9;22)(q34;q11.2);BCR-ABL1; untreated adult ALL |
| Â | National Cancer Institute | Â | Â | Â | Phase III, NCT02003222 | BCR-ABL-negative B lineage ALL |
Solitomab (MT110, AMG 110) | Amgen Research (Munich) GmbH | BiTE | CD3 × EpCAM | T cell recruitment | Completed phase I, NCT00635596 | Solid tumors |
AMG 330 | Amgen | BiTE | CD33 × CD3 | T cell recruitment | Phase I, NCT02520427 | Relapsed/refractory AML |
MT112 (BAY2010112) | Bayer | BiTE | PSMA × CD3 | T cell recruitment | Phase I, NCT01723475 | Prostatic neoplasms |
MT111 (MEDI-565) | MedImmune LLC | BiTE | CEA × CD3 | T cell recruitment | Completed phase I, NCT01284231 | Gastrointestinal adenocarcinomas |
BAY2010112 | Bayer | BiTE | CD3 × PSMA | T cell recruitment | Phase I, NCT01723475 | Prostatic neoplasms |
MEDI-565 | MedImmune LLC | BiTE | CEA × CD3 | T cell recruitment | Completed phase I, NCT01284231 | Gastrointestinal adenocarcinomas |
MDX447 | Dartmouth-Hitchcock Medical Center | 2 (Fab’) was crosslinked | CD64 × EGFR | Active monocytes to kill tumor | Completed phase I, NCT00005813 | Brain and central nervous system rumors |
TF2 | Garden State Cancer Center at the Center for Molecular Medicine and Immunology | Dock and lock | CEA × HSG | Enzyme-linked immunosorbent assay | Phase I, NCT00895323 | Colorectal cancer |
|  | Centre René Gauducheau |  |  | Radioimmunotherapy | Phase I/II, NCT01221675 | Small cell lung cancer |
| Â | Nantes University Hospital | Â | Â | Immuno-PET | Phase I/II, NCT01730638 | Recurrences of medullary thyroid carcinoma |
| Â | Nantes University Hospital | Â | Â | Immuno-PET | Phase I/II, NCT01730612 | HER2 negative breast carcinoma expressing CEA |
| Â | Radboud University | Â | Â | Radioimmunotherapy | Completed phase I, NCT00860860 | Colorectal neoplasms |
rM28 | University Hospital Tuebingen | Tandem scFv | CD28 × HMV-MAA | Retargeting autologous lymphocytes to tumor | Phase I/II, NCT00204594 | Malignant melanoma |
HER2Bi-aATC | Barbara Ann Karmanos Cancer Institute | T cells preloaded with bsAbs | CD3 × HER2 | Activated T cells | Phase I, NCT02470559 | Ovarian, fallopian tube, or primary peritoneal cancer |
GD2Bi-aATC | Barbara Ann Karmanos Cancer Institute | T cells preloaded with bsAbs | CD3 × GD2 | Activated T cells | Phase I/II, NCT02173093 | Children and young adults with neuroblastoma and osteosarcoma |
| Â | Barbara Ann Karmanos Cancer Institute | Â | Â | Â | Completed phase I, NCT00938626 | Multiple myeloma and plasma cell neoplasm |
| Â | Barbara Ann Karmanos Cancer Institute | Â | Â | Â | Completed phase 1, NCT00244946 | NHL |
EGFRBi-aATC | Barbara Ann Karmanos Cancer Institute | T cells preloaded with BsAb | CD3 × EGFR | Autologous activated T cells to EGFR-positive tumor | Phase I/II, NCT02521090 | Adult brain glioblastoma; adult gliosarcoma; recurrent brain neoplasm |
MGD006 | MacroGenics | DART | CD123 × CD3 | Retargeting of T cells to tumor | Phase I, NCT02152956 | Relapsed/refractory AML |
MGD007 | MacroGenics | DART | gpA33 × CD3 | Retargeting of T cells to tumor | Phase I, NCT02248805 | Colorectal carcinoma |
MGD010 | MacroGenics | DART | CD32B × CD79B |  | Phase I, NCT02376036 | Healthy subjects |
Anti-CEAxanti-DTPA | Nantes University Hospital | scFv-IgG | CEA × di-DTPA-131I | Radioimmunotherapy | Complete phase II, NCT00467506 | Medullary thyroid carcinoma |
DT2219ARL | Masonic Cancer Center | 2 scFv linked to diphtheria toxin | CD19 × CD22 | Targeting of protein toxin to tumor | Phase I, NCT00889408 | Leukemia; lymphoma |
| Â | Masonic Cancer Center | Â | Â | Â | Phase I/II, NCT02370160 | Relapsed or refractory B lineage leukemia or lymphoma |
IMCgp100 | Immunocore Ltd | ImmTAC | CD3 × gp100 | T cell recruitment | Phase I, NCT01211262 | Malignant melanoma |
| Â | Â | Â | Â | Â | Phase I, NCT02570308 | Uveal melanoma |
Indium-labeled IMP-205xm734 | Radboud University | Unclear | CEA × in-labeled Peptide | Nuclear imaging | Phase I,NCT0018508 | Colorectal cancer |
LY3164530 | Eli Lilly and Company | OrthoFab-IgG | MET × EGFR | Blockade of 2 receptors | Phase I, NCT02221882 | Neoplasms; neoplasm metastasis |
OMP-305B83 | OncoMed Pharmaceuticals, Inc. | DVD-Ig | DLL4 × VEGF | 2-ligand inactivation | Phase I, NCT02298387 | Advanced solid tumor malignancies |
REGN1979 | Regeneron Pharmaceuticals | Unclear | CD20 × CD3 | T cell recruitment | Phase I, NCT02290951 | CD20+ B cell malignancies |
COVA322 | Covagen | IgG-fynomer | TNF-α × IL17A | Blockade of two proinflammatory cytokines | Phase I/II, NCT02243787 | Plaque psoriasis |
RG7802 | Hoffmann-La Roche | CrossMab | CEA × CD3 | T cell recruitment | Phase I, NCT02324257 | Solid cancers |
RG7813 (RO6895882) | Hoffmann-La Roche | ScFv-IgG | CEA × IL2 | The delivery of cytokines | Phase I, NCT02004106 | Advanced and/or metastatic solid CEA+ tumors |
RG7221 (RO5520985) | Hoffmann-La Roche | CrossMAb | Ang-2 × VEGF | 2-ligand inactivation | Phase II, NCT01688206 | Neoplasms |
RG7716 | Hoffmann-La Roche | CrossMAb | VEGF × Ang-2 | 2-ligand inactivation | Phase II,NCT02484690 | Wet AMD |
MM-111 | Merrimack Pharmaceuticals | HSA body | HER2 × HER3 | Blockade of 2 receptors | Completed phase I, NCT01097460 | Breast neoplasms |
| Â | Merrimack Pharmaceuticals | Â | Â | Blockade of 2 receptors | Completed phase I, NCT00911898 | Her2-amplified solid tumors |
MM-141 | Merrimack Pharmaceuticals | scFv-IgG | IGF-IR × HER3 | Blockade of 2 receptors | Phase I, NCT01733004 | Hepatocellular carcinoma |
| Â | Â | Â | Â | Â | Phase II, NCT02399137 | Pancreatic cancer |
MOR209/ES414 | Emergent Product Development Seattle LLC | scFv-IgG | PSMA × CD3 | T cell recruitment | Phase I, NCT02262910 | Prostate cancer |
TargomiRs | University of Sydney | Unclear | EGFR × EDV | Delivery of nanoparticles | Phase I, NCT02369198 | Recurrent MPM and NSCLC |
MSB0010841 | Merck KGaA | Nanobody | IL-17A/F | Blockade of 2 proinflammatory cytokines | Phase I, NCT02156466 | Psoriasis |
ALX-0061 | Ablynx | Nanobody | IL-6R × HSA | Blockade of proinflammatory cytokine, binds to HSA to increase half-life | Completed phase I/II, NCT01284569 | Rheumatoid arthritis |
Ozoralizumab (ATN-103) | Ablynx | Nanobody | TNF × HSA | Blockade of proinflammatory cytokine binds to HSA to increase half-life | Completed phase II, NCT01063803 | Rheumatoid arthritis |
AFM13 | University of Cologne | TandAb | CD30 × CD16A | Active NK cells | Phase II, NCT02321592 | Relapsed or refractory Hodgkin lymphoma |
AFM11 | Affimed GmbH | TandAb | CD30 × CD19 | Redirecting of T cells | Phase I, NCT02106091 | Relapsed and/or refractory CD19-positive B cell NHL |
SAR156597 | Sanofi | scFv-IgG | IL4 × IL13 | Blockade of proinflammatory cytokines | Completed phase I/II, NCT01529853 | Idiopathic pulmonary fibrosis |
| Â | Sanofi | Â | Â | Â | Phase II, NCT02345070 | Idiopathic pulmonary fibrosis |