Table 4 Recent clinical trials involving the use of bispecific antibodies in solid tumor malignancies
From: Bi-specific and tri-specific antibodies- the next big thing in solid tumor therapeutics
Drug name | Antibody type | Sponsor | Target antigens | Development stage | Indication | Status | Clinical trials identifier |
|---|---|---|---|---|---|---|---|
Selicrelumab Vanucizumab Bevacizumab | CrossMab | Hoffmann-La Roche | Ang2, VEGF | Phase I | Advanced/ Metastatic Solid Tumors | Recruiting | NCT02665416 |
rM28, autologous PBMCs | Tandem ScFv | University Hospital Tuebingen | CD28, HMV-MMA | Phase I/Phase II | Stage III/IV metastatic melanoma | Completed | NCT00204594 |
Indium labeled IMP-205xm734 | IgG type bispecific antibody | Radboud University | CEA | Phase I | Colorectal carcinoma | Completed | NCT00185081 |
Obinutuzumab, RO6958688 | IgG type T cell bispecific antibody | Hoffmann-La Roche | CEA, CD3 | Phase I | Locally advanced or Metastatic Solid Tumors | Active, not recruiting | NCT02324257 |
MEDI 565 | BITE | MedImmune LLC | CEA, CD3 | Phase I | Gastrointestinal Adenocarcinomas | Completed | NCT01284231 |
Anti-CEA x anti-DTPA | Fusion of two Fab fragments | Nantes University Hospital | CEA, DTPA | Phase II | Medullary Thyroid Carcinoma | Completed | NCT00467506 |
anti-CEA x anti-HSG TF-2 | Dock and lock bispecific antibody | Garden State Cancer Center at the Center for Molecular Medicine and Immunology | CEA, HSG | Phase I | Detection of Colorectal Carcinoma | Unknown | NCT00895323 |
TF2 antibody/68Ga-IMP-288 | Gallium labeled Dock and lock bispecific antibody | Nantes University Hospital | CEA, HSG | Phase II | Metastatic Colorectal Cancer | Completed | NCT02587247 |
TF2–68 Ga-IMP-288 | Gallium labeled Dock and lock bispecific antibody | Nantes University Hospital | CEA, HSG | Phase I/Phase II | HER2 negative Breast Carcinoma expressing CEA | Active, not recruiting | NCT01730612 |
Anti- CEA x Anti-HSG TF2, Radiation | Dock and lock bispecific antibody | Centre René Gauducheau | CEA, HSG | Phase I/Phase II | Small Cell Lung Cancer CEA-Expressing NSCLC | Completed | NCT01221675 |
TF2 and 68Â Ga- IMP-288 | Gallium labeled Dock and lock bispecific antibody | Nantes University Hospital | CEA, HSG | Phase I/ Phase II | Medullary Thyroid Carcinoma | Completed | NCT01730638 |
TF-2, IMP-288 labeled with In111 and Lu177 | Dock and lock bispecific antibody | Radboud University | CEA, Lu177- labeled peptide | Phase I | Colorectal cancer | Completed | NCT00860860 |
AMG 757 | BITE | Amgen | DLL3 | Phase I | Small Cell Lung Cancer | Recruiting | NCT03319940 |
NOV1501 | IgG type bispecific antibody | National OncoVenture | DLL4, VEGF | Phase I | Advanced Solid Tumors | Recruiting | NCT03292783 |
OMP-305B83 | IgG type bispecific monoclonal antibody | OncoMed Pharmaceuticals | DLL4, VEGF | Phase I | Metastatic Colorectal Cancer | Recruiting | NCT03035253 |
OMP-305B83 | IgG type bispecific monoclonal antibody | OncoMed Pharmaceuticals | DLL4, VEGF | Phase I | Previously Treated Solid Tumors | Active, not recruiting | NCT02298387 |
OMP-305B83, Paclitaxel | IgG type bispecific monoclonal antibody | OncoMed Pharmaceuticals | DLL4, VEGF | Phase I | Ovarian, Peritoneal or Fallopian Tube Cancer | Recruiting | NCT03030287 |
EEDVsMit | Nanocell coated with IgG type bispecific antibody and mitoxantrone payload | Dr. David Ziegler | EGFR | Phase I | Refractory solid or CNS tumors expressing EGFR | Recruiting | NCT02687386 |
EGFR (V)- EDV- Dox | Nanocell coated with IgG type bispecific antibody and doxorubicin payload | Engeneic Pty Limited | EGFR | Phase I | Recurrent Glioblastoma Multiforme | Recruiting | NCT02766699 |
TargomiRs | Nanocell coated with IgG type bispecific antibody containing microRNA | Asbestos Disease Research Foundation | EGFR | Phase I | Recurrent malignant pleural mesothelioma Non-small cell lung cancer | Completed | NCT02369198 |
MDX447 | IgG type bispecific antibody | Dartmouth- Hitchcock Medical Center | EGFR | Phase I | Brain and Central Nervous System Tumors | Completed | NCT00005813 |
Anti-CD3x anti- EGFR bispecific armed activated T cells (BATs), Aldesleukin, Sargramostim | T cells preloaded with IgG type bispecific antibody | Barbara Ann Karmanos Cancer Institute | EGFR, CD3 | Phase I/ Phase II | Locally advanced, metastatic, or recurrent pancreatic cancer | Active, not recruiting | NCT02620865 |
EGFR BATs | T cells preloaded with IgG type bispecific antibody | University of Virginia | EGFR, CD3 | Phase I/ Phase II | Locally advanced and metastatic pancreatic cancer | Recruiting | NCT03269526 |
Anti-CD3 x Anti-EGFR BATs with radiation and temozolomide | T cells preloaded with IgG type bispecific antibody | University of Virginia | EGFR, CD3 | Phase I | Glioblastoma Multiforme | Recruiting | NCT03344250 |
JNJ-61186372 | IgG1 type bispecific antibody | Janssen Research and Development LLC | EGFR, cMet | Phase I | Advanced non-small cell lung cancer | Recruiting | NCT02609776 |
MCLA-158 | IgG1 bispecific antibody | Merus N.V. | EGFR, LGR5 | Phase I | Metastatic Colorectal Cancer and select advanced solid tumors | Recruiting | NCT03526835 |
Catumaxomab | Trifunctional IgG type antibody | AGO Study Group | EpCAM, CD3 | Phase II | Ovarian cancer, Fallopian Tube Neoplasms, Peritoneal Neoplasms | Completed | NCT00189345 |
Catumaxomab | Trifunctional IgG type antibody | Neovii Biotech | EpCAM, CD3 | Phase II/Phase III | Malignant ascites EpCam positive tumors | Completed | NCT00836654 |
Catumaxomab | Trifunctional IgG type antibody | Neovii Biotech | EpCAM, CD3 | Phase II | Gastric Adenocarcinoma after neoadjuvant chemotherapy and curative resection | Completed | NCT00464893 |
Catumaxomab | Trifunctional IgG type antibody | Neovii Biotech | EpCAM, CD3 | Phase II | Gastric Adenocarcinoma after curative resection | Completed | NCT00352833 |
MT110 | BITE | Amgen Research (Munich) | EpCAM, CD3 | Phase I | Gastric Cancer or Adenocarcinoma of the Gastro-esophageal Junction, Colorectal Cancer, Breast Cancer, Hormone-Refractory Prostate Cancer, Ovarian Cancer | Completed | NCT00635596 |
GD2Bi-aATC | T cells preloaded with IgG type bispecific antibody | Barbara Ann Karmanos Cancer Institute | GD2 | Phase I/ II | Desmoplastic small round cell tumor, Disseminated neuroblastoma, Metastatic Osteosarcoma, Recurrent Neuroblastoma, Recurrent Osteosarcoma | Recruiting | NCT02173093 |
MGD007 | DART | MacroGenics | gpA33, CD3 | Phase I | Relapsed/Refractory Metastatic Colorectal Cancer | Recruiting | NCT02248805 |
MGD007 and MGA012 | DART | MacroGenics | gpA33, CD3, PD-1 | Phase I/ Phase II | Relapsed/ Refractory Metastatic Colon Cancer | Recruiting | NCT03531632 |
ERY974 | IgG4 bispecific T cell-redirecting antibody | Chugai Pharmaceutical | GPC3, CD3 | Phase I | Solid Tumors | Recruiting | NCT02748837 |
MM-111 | Bispecific antibody fusion protein | Merrimack Pharmaceuticals | HER2 | Phase I | HER2 Amplified Solid Tumors Metastatic Breast Cancer | Completed | NCT00911898 |
MM-111, Herceptin | Bispecific antibody fusion protein | Merrimack Pharmaceuticals | HER2 | Phase I | Refractory HER 2 Amplified Heregulin Positive Breast Cancer | Completed | NCT01097460 |
ZW25 | IgG type bispecific antibody | Zymeworks Inc. | HER2 | Phase I | Unresectable and/or metastatic HER2 positive cancers | Recruiting | NCT02892123 |
Her2 BATs, Recombinant IL-2 | T cells preloaded with IgG type bispecific antibody | Yi Miao | HER2 | Phase I | Her2 Positive Neoplasms of Digestive System | Unknown | NCT02662348 |
MCLA-128 | IgG type bispecific antibody | Merus N.V. | HER2 and HER3 | Phase I/Phase II | Malignant solid tumor Breast cancer Gastric cancer Ovarian cancer Endometrial cancer Non- Small cell lung cancer | Recruiting | NCT02912949 |
HER-2 BATs with Pembrolizumab | T cells preloaded with IgG type bispecific antibody | University of Virginia | HER2 specific antibody armed activated T cell infusions | Phase I/Phase II | Metastatic Breast Cancer | Recruiting | NCT03272334 |
Anti-CD3 x HER2- BATs | T cells preloaded with IgG type bispecific antibody | Barbara Ann Karmanos Cancer Institute | HER2, CD3 | Phase II | Metastatic Castration Resistant Prostate Cancer | Recruiting | NCT03406858 |
GBR1302 | BEAT-bispecific antibody with heavy chain, light chain and Fc-scFv | Glenmark Pharmaceuticals S.A. | HER2, CD3 | Phase I | HER2 Expressing Solid Tumors | Recruiting | NCT02829372 |
HER2- BATs, Pembrolizumab | T cells preloaded with IgG type bispecific antibody | University of Virginia | HER2, CD3, PD-1 | Phase I/ Phase II | Metastatic Breast Cancer | Recruiting | NCT03272334 |
MCLA-128/ trastuzumab/chemotherapy, MCLA-128, endocrine therapy | IgG type bispecific antibody | Merus N.V. | HER2, ER | Phase II | Metastatic Breast Cancer | Not yet recruiting | NCT03321981 |
IMCgp100 | TCR fused to ScFv | Immunocore Ltd. | HLA A2, CD3 | Phase I | Advanced Malignant Melanoma | Completed | NCT01211262 |
FS118 | IgG type bispecific antibody with Fc capable of antigen binding | F-star Delta Limited | LAG3, PD-L1 | Phase I | Advanced Malignancies | Recruiting | NCT03440437 |
LY3164530 | IgG4 antibody combined with scFV | Eli Lilly and Company | MET and Anti- EGFR | Phase I | Metastatic neoplasm including NSCLC | Completed | NCT02221882 |
Anti-CD3-MUC1 and Activated CIK | Fusion of two Fab fragments | Benhealth Biopharmaceutical (Shenzhen) Co., Ltd | MUC1, CD3 | Phase II | Advanced liver cancer | Recruiting | NCT03146637 |
Activated CIK with CD3-MUC1 | Fusion of two Fab fragments | Fuda Cancer Hospital, Guangzhou | MUC1, CD3 | Phase II | Advanced liver cancer | Recruiting | NCT03484962 |
Activated CIK with CD3-MUC1 | Fusion of two Fab fragments | Fuda Cancer Hospital, Guangzhou | MUC1, CD3 | Phase II | Advanced gastric cancer | Recruiting | NCT03554395 |
Activated CIK with CD3-MUC1 | Fusion of two Fab fragments | Fuda Cancer Hospital, Guangzhou | MUC1, CD3 | Phase II | Advanced kidney cancer | Recruiting | NCT03540199 |
Activated CIK with CD3- MUC1 | Fusion of two Fab fragments | Fuda Cancer Hospital, Guangzhou | MUC1, CD3 | Phase II | Advanced breast cancer | Recruiting | NCT03524261 |
Activated CIK with CD3- MUC1 | Fusion of two Fab fragments | Fuda Cancer Hospital, Guangzhou | MUC1, CD3 | Phase II | Advanced lung cancer | Recruiting | NCT03501056 |
Activated CIK with CD3-MUC1 | Fusion of two Fab fragments | Fuda Cancer Hospital, Guangzhou | MUC1, CD3 | Phase II | Advanced colorectal cancer | Recruiting | NCT03524274 |
Activated CIK with CD3-MUC1 | Fusion of two Fab fragments | Fuda Cancer Hospital, Guangzhou | MUC1, CD3 | Phase II | Advanced pancreatic cancer | Recruiting | NCT03509298 |
PF-06671008 | DART | Pfizer | P-Cadherin, CD3 | Phase I | Advanced Solid Tumors | Recruiting | NCT02659631 |
XmAb20717 | Fc engineered bispecific antibody | Xencor | PD1, CTLA4 | Phase I | Selected Advanced Solid Tumors | Recruiting | NCT03517488 |
MGD013 | DART | MacroGenics | PDL-1, LAG-3 | Phase I | Unresectable or Metastatic Neoplasm | Recruiting | NCT03219268 |
ES414 | scFv domains linked to Fc of IgG1 | Aptevo Therapeutics | PSMA, CD3 | Phase I | Metastatic Castration Resistant Prostate Cancer | Recruiting | NCT02262910 |
BAY2010112 | BITE | Bayer | PSMA, CD3 | Phase I | Castration Resistant Prostate Cancer | Active, not recruiting | NCT01723475 |
XmAb18087 | Fc engineered bispecific antibody | Xencor | SSTR2, CD3 | Phase I | Advanced Neuroendocrine Tumor and Gastrointestinal Stromal Tumors | Recruiting | NCT03411915 |