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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 68 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