Trial Watch

Figures & data

Table 1. Tumor-targeting mAbs currently approved for cancer therapy.*^,**

mAb	Target	Approved	Type	Indication(s)
Alemtuzumab	CD52	2001	Hzed IgG1	Chronic lymphocytic leukemia
Bevacizumab	VEGF	2004	Hzed IgG1	Glioblastoma multiforme, colorectal, renal and lung cancer
Brentuximab vedotin	CD30	2011	C IgG1	Hodgkin's and anaplastic large cell lymphoma (coupled to MMAE)
Catumaxomab	CD3 EPCAM	2009	M-R hybrid	Malignant ascites in patients with EPCAM^+ cancer
Cetuximab	EGFR	2004	C IgG1	HNC and colorectal carcinoma
Denosumab	RANKL	2011	H IgG2	Breast cancer, prostate carcinoma and giant cell tumors of the bone
Gemtuzumab ozogamicin	CD33	2000	Hzed IgG4	Acute myeloid leukemia (coupled with calicheamicin)
Ibritumomab tiuxetan	CD20	2002	M IgG1	Non-Hodgkin lymphoma (coupled with ^90Y or ^111In)
Panitumumab	EGFR	2006	H IgG2	Colorectal carcinoma
Pertuzumab	HER2	2012	Hzed IgG1	Breast carcinoma
Ofatumumab	CD20	2009	H IgG1	Chronic lymphocytic leukemia
Rituximab	CD20	1997	C IgG1	Chronic lymphocytic leukemia and non-Hodgkin lymphoma
Tositumomab	CD20	2003	H IgG1	Non-Hodgkin lymphoma (naked or coupled with ^131I)
Trastuzumab (emtansine)	HER2	1998	Hzed IgG1	Breast carcinoma (naked or coupled to mertansine) and gastric or gastresophageal junction cancer

Abbreviations: C, chimeric; EGFR, epidermal growth factor receptor; EPCAM, epithelial cell adhesion molecule; H, human; HNC, head and neck cancer; Hzed, humanized; M, murine; mAb, monoclonal antibody; MMAE, monomethyl auristatin E; R, rat; RANKL, receptor activator of NF-κB ligand; VEGF, vascular endothelial growth factor. *by the US Food and Drug Administration or European Medicines Agency at the day of submission. **updated from ref.12

Table 2. Recently published clinical trials assessing the therapeutic profile of hitherto investigational tumor-targeting mAbs.^*,**

mAb	Target(s)	Indication(s)	Phase	Note	Ref.
1D09C3	HLA-DR	CLL Lymphoma	I	As single agent	94
AGS-1C4D4	PSCA	Pancreatic cancer	II	Combined with gemcitabine	95
AVE1642	IGF1R	Solid tumors	I	Combined with docetaxel	60
			I	Combined with docetaxel, gemcitabine, erlotinib or doxorubicin	59
Blinatumomab (MEDI-538)	CD3 CD19	Acute lymphoblastic leukemia	II	As single agent or followed by HSCT	96
Carlumab (CNTO 888)	CCL2	Prostate cancer	II	As single agent	88
		Solid tumors	I	As single agent	86
Cixutumumab (IMC-A12)	IGF1R	Bone or soft-tissue sarcomas	II	Combined with temsirolimus	56
		Renal cell carcinoma	I	Combined with temsirolimus	249
Clivatuzumab tetraxetan	MUC1	Pancreatic cancer	I	Coupled with ^90Y and combined with low-dose gemcitabine	115
Conatumumab (AMG 655)	TRAILR2	Colorectal carcinoma	II	Combined with bevacizumab plus folinic acid-, 5-FU- and oxaliplatin-based chemotherapy	65
		Lung cancer	II	Combined with paclitaxel plus carboplatin	64
		Pancreatic cancer	II	Combined with ganitumab and gemcitabine	57
Drozitumab (PRO95780)	TRAILR2	Colorectal carcinoma	Ib	Combined with bevacizumab plus folinic acid-, 5-FU- and oxaliplatin-based chemotherapy	67
Farletuzumab (MORAb-003)	FOLR1	Ovarian carcinoma	II	As single agent or combined with platinum- or taxane-based chemotherapy	97
GC33 (RO5137382)	GPC3	Hepatocellular carcinoma	I	As single agent	98
Ganitumab (AMG 479)	IGF1R	Breast carcinoma	II	As single agent	58
		Pancreatic cancer	II	Combined with conatumumab and gemcitabine	57
Inotuzumab ozogamicin (CMC-544)	CD22	Non-Hodgkin’s lymphoma	I/II	Combined with rituximab	99
Intetumumab (CNTO 95)	ITGA5	Prostate cancer	II	Combined with docetaxel and prednisone	100
KRN330	GPA33	Colorectal cancer	I	As single agent	101
L19	FN1	Solid tumors	I/II	As a shuttle to deliver TNFα to the tumor vasculature	118
Lexatumumab (HGS-ETR2)	TRAILR2	Solid tumors	I	As single agent	66
Lintuzumab (SGN-33)	CD33	Acute myeloid leukemia	IIb	Combined with low-dose cytarabine	106
MIK-β1 (MA1–35896)	IL2RB	T-LGL leukemia	I	As single agent	93
Nimotuzumab (h-R3)	EGFR	NSCLC	I	Combined with gefitinib	102
Obinutuzumab (GA101)	CD20	Non-Hodgkin’s lymphoma	I	As single agent	103
Rilotumumab (AMG 102)	HGF	Prostate cancer	II	Combined with mitoxantrone plus prednisone	91
Ramucirumab (IMC-1121B)	VEGFR2	Hepatocellular carcinoma	II	As single agent	77
		Gastresophageal adenocarcinoma	III	As single agent	76
		Lung cancer	III	Combined with docetaxel	78
Trebananib (AMG 386)	ANGPT1 ANGPT2	Solid tumors	I	As single agent	87
Volociximab (M200)	ITGA5 ITGB1	NSCLC	Ib	Combined with carboplatin and paclitax	105

Abbreviations: 5-FU, 5-fluorouracil; ANGPT, angiopoietin; CCL2, chemokine (C-C motif) ligand 2; CLL; chronic lymphocytic leukemia; EGFR, epidermal growth factor receptor; FN1, fibronectin 1; FOLR1, folate receptor 1 (adult); GPA33, glycoprotein A33; GPC3, glypican 3; HGF, hepatocyte growth factor; HSCT, hematopoietic stem cell transplantation; IGF1R, insulin-like growth factor 1 receptor; IL2RB, IL-2 receptor β; ITGA5, integrin α5; ITGB1, integrin β1; mAb, monoclonal antibody; MUC1, mucin 1; NSCLC, non-small cell lung carcinoma; PSCA, prostate stem cell antigen; T-LGL, T-cell large granular lymphocytic; TRAILR2, TNFα-related apoptosis-inducing ligand receptor 2; VEGFR2, vascular endothelial growth factor receptor 2. *between 2012, October 1st and the day of submission. **refers to mAbs that directly bind cancer cells or block trophic signals provided by the tumor stroma.

Table 3. Recently published clinical trials assessing the therapeutic profile of FDA-approved tumor-targeting mAbs employed as off-label anticancer interventions.^*,**

mAb	Target(s)	Indication(s)	Phase	Note	Ref.
Bevacizumab	VEGF	Angiosarcoma and epithelioid hemangioendotheliomas	II	As a single agent	152
		Breast carcinoma	n.a.	Coupled to ^89Zr as a diagnostic tool	153
			II	Combined with docetaxel plus capecitabine	124
			II	Combined with docetaxel plus cisplatin	126
			II	Combined with gemcitabine	127
			II	Combined with trastuzumab plus docetaxel	48
			III	Combined with docetaxel	123
			III	Combined with capecitabine or paclitaxel	128
			III	Combined with capecitabine or paclitaxel	125
			III	Combined with trastuzumab plus docetaxel	154
		Cervical cancer	II	Combined with topotecan plus cisplatin	145
		Colorectal carcinoma	II/III	Combined with folinic acid, 5-FU, oxaliplatin and irinotecan	143
		Endometrial carcinoma	II	Combined with temsirolimus	148
		Gastresophageal adenocarcinoma	II/III	Combined with epirubicin, cisplatin and capecitabine	150
		Hepatocellular carcinoma	n.a.	Combined with erlotinib	131
			I	Combined with rapamycin	130
			II	Combined with erlotinib	133
			II	Combined with erlotinib	132
			II	After transhepatic arterial chemoembolization	134
		HNSCC	II	Combined with cisplatin plus IRMT	121
			II	Combined with cetuximab	122
		Leukemia	II	Combined with cytarabine	119
		Melanoma	II	Combined with temozolomide or albumin-bound paclitaxel plus carboplatin	129
		Multiple myeloma	II	Combined with bortezomib	120
		Ovarian carcinoma	n.a.	As a single agent	137
			n.a.	Combined with gemcitabine plus oxaliplatin	138
			II	Combined with docetaxel within 12 months of platinum-based therapy	136
			II	Combined with PLD	141
			II	Combined with albumin-bound paclitaxel	140
			III	Combined with carboplatin plus paclitaxel	139
		Pancreatic cancer	II	Combined with gemcitabine plus 5-FU	135
		Prostate cancer	II	Combined with docetaxel	142
		Urothelial carcinoma	II	Combined with gemcitabine plus carboplatin	147
		Metastatic solid tumors	I	Combined with vincristine, irinotecan and temozolomide	144
			I	Combined with albumin-bound paclitaxel plus gemcitabine	146
			I	Combined with sorafenib plus low-dose cyclophosphamide	149
			I	Combined with temsirolimus plus liposomal doxorubicin	151
Cetuximab	EGFR	Bone or soft-tissue sarcomas	II	As a single agent	177
		Breast carcinoma	II	Combined with cisplatin	164
		Cervical cancer	I	Combined with cisplatin	175
		Esophageal cancer	I	As part of a chemoradiotherapeutic regimen	166
			II/III	As part of a chemoradiotherapeutic regimen	165
		Gastric cancer	III	Combined with capecitabine plus cisplatin	167
		Lung cancer	I	Combined with bevacizumab plus erlotinib	168
			II	Combined with bevacizumab, paclitaxel and carboplatin	169
		Pancreatic cancer	n.a.	Combined with gemcitabine plus IRMT	170
			II	Combined with gemcitabine plus oxaliplatin	171
			I/II	Combined with everolimus plus capecitabine	172
		Prostate cancer	II	Combined with docetaxel	174
		Urothelial carcinoma	II	Combined with paclitaxel	176
		Solid tumors	n.a.	As a single agent	173
			I	As a carrier for doxorubicin-loaded immunoliposomes	178
Denosumab	RANKL	Lung cancer	III	As a single agent	179
Ofatumumab	CD20	Small lymphocytic lymphoma	I	As single agent	184
Panitumumab	EGFR	Gastresophagic cancer	III	Combined with epirubicin, oxaliplatin and capecitabine	183
		HNSCC	III	Combined with cisplatin plus 5-FU	180
		Ovarian carcinoma	II	Combined with PLD	181
Pertuzumab	HER2	NSCLC	Ib	Combined with erlotinib	185
		Ovarian carcinoma	II	Combined with carboplatin	186
Rituximab	CD20	B-cell malignancies	I	Combined with rIL-21	182

Abbreviations: 5-FU, 5-fluorouracil; EGFR, epidermal growth factor receptor; HNSCC, head and neck squamous cell carcinoma; IL, interleukin; IMRT, intensity-modulated radiation therapy; mAb, monoclonal antibody; n.a., not available; NSCLC, non-small cell lung carcinoma; PLD, pegylated liposomal doxorubicin; r, recombinant; RANKL, receptor activator of NF-κB ligand; VEGF, vascular endothelial growth factor. *between 2012, October 1st and the day of submission. **refers to mAbs that directly bind cancer cells or block trophic signals provided by the tumor stroma.

Table 4. Clinical trials recently launched to evaluate the therapeutic profile of tumor-targeting monoclonal antibodies in investigational settings.^*,**

mAb	Target(s)	Indication(s)	Phase	Status	Note	Ref.
Alemtuzumab	CD52	Hematological malignancies	I/II	Not yet recruiting	In combination with genetically modified T cells	NCT01875237
		Peripheral T-cell lymphoma	II	Completed	As a consolidation regimen upon cyclophosphamide-based chemotherapy	NCT01806337
BC8	CD45	Hematological malignancies	I/II	Not yet recruiting	Followed by BEAM chemotherapy and ASCT	NCT01921387
Bevacizumab	VEGF	Brain tumors	II	Recruiting	As single agent	NCT01767792
		Breast carcinoma	0	Not yet recruiting	As ^89Zr-bevacizumab radiotracer	NCT01894451
			II	Not yet recruiting	Combined with carboplatin, cyclophosphamide or paclitaxel	NCT01898117
			II	Not yet recruiting	Combined with eribulin	NCT01941407
			II	Not yet recruiting	Combined with cyclophosphamide, doxorubicin and paclitaxel	NCT01959490
			II	Recruiting	Combined with paclitaxel	NCT01722968
		Glioma	I/II	Recruiting	Combined with temozolomide and vitamin C	NCT01891747
			II	Recruiting	Combined with radiation therapy	NCT01743950
		Lymphoma	II	Recruiting	Combined with gemcitabine-based chemotherapy	NCT01921790
		Melanoma	II	Not yet recruiting	Combined with paclitaxel-based chemotherapy	NCT01879306
			II	Not yet recruiting	Combined with ipilimumab	NCT01950390
		MM	n.a.	Recruiting	As ^89Zr-bevacizumab radiotracer	NCT01859234
		Ovarian cancer	II	Not yet recruiting	Combined with trabectedin ± carboplatin	NCT01735071
			II	Recruiting	Combined with carboplatin and paclitaxel	NCT01739218
			II	Recruiting	Combined with paclitaxel	NCT01770301
			II	Recruiting	Combined with carboplatin and paclitaxel	NCT01838538
			II	Recruiting	Combined with carboplatin and paclitaxel	NCT01847677
			III	Active not recruiting	Combined with carboplatin and PLD	NCT01837251
			III	Not yet recruiting	Combined with carboplatin and gemcitabine or paclitaxel or PLD	NCT01802749
		Reproductive tract cancers	II	Recruiting	Combined with carboplatin and paclitaxel	NCT01770171
			II	Recruiting	Combined with gemcitabine ± platinum based chemotherapy	NCT01936974
			II	Terminated with results	Followed by abraxane infusion	NCT01821859
		Rhabdomyosarcoma	II	Recruiting	Combined with cyclophosphamide-based chemotherapy	NCT01871766
		Sarcoma	I	Recruiting	Combined with doxorubicin and radiation therapy	NCT01746238
		Sarcoma and neuroectodermal tumors	II	Not yet recruiting	Combined with cyclophosphamide-based chemotherapy	NCT01946529
		Advanced or metastatic solid tumors	I	Not yet recruiting	Combined with lurbinectedin and paclitaxel	NCT01831089
			I	Recruiting	Combined with tivantinib	NCT01749384
			I	Recruiting	As single agent	NCT01847118
			II	Not yet recruiting	As single agent	NCT01898130
			II	Recruiting	Combined with cisplatin and pemetrexed	NCT01951482
Blinatumomab	CD3 CD19	DLBCL	II	Recruiting	As single agent	NCT01741792
Brentuximab vedotin	CD30	AML	I	Recruiting	Combined with immunogenic chemotherapy	NCT01830777
		DLBCL	II	Recruiting	Combined with cyclophosphamide-based chemotherapy	NCT01925612
		Germ cell tumors	II	Not yet recruiting	As single agent	NCT01851200
		Lymphoma	I/II	Recruiting	Combined with rituximab	NCT01805037
			III	Recruiting	Combined with cyclophosphamide-based chemotherapy	NCT01777152
		Mast cell leukemia	n.a.	Not yet recruiting	As single agent	NCT01807598
		Peripheral T-cell lymphoma	n.a.	Not yet recruiting	As single agent	NCT01841021
Catumaxomab	CD3 EPCAM	Gastric peritoneal carcinomatosis	II	Recruiting	As single agent	NCT01784900
		Ovarian cancer	II	Recruiting	As single agent	NCT01815528
Cetuximab	EGFR	Brain tumors	I/II	Recruiting	Combined with bevacizumab	NCT01884740
		Esophageal cancer Gastric cancer	II	Recruiting	Combined with cisplatin, 5-FU and radiotherapy	NCT01787006
			II	Completed	Combined with carboplatin, paclitaxel and radiotherapy	NCT01904435
		Advanced solid tumors	I	Recruiting	Combined with erlotinib	NCT01727869
			I	Recruiting	Combined with irinotecan and vemurafenib	NCT01787500
Ch14.18	GD2	Neuroblastoma	II	Recruiting	Combined with irinotecan and temozolomide	NCT01767194
Conatumumab	TRAILR2	Reproductive tract cancers	I	Not yet recruiting	Combined with birinapant	NCT01940172
Denosumab	RANKL	NSCLC	II	Not yet recruiting	As single agent	NCT01951586
Lintuzumab	CD33	Leukemia	I/II	Recruiting	Combined with cytarabine	NCT01756677
Necitumumab	EGFR	NSCLC	I/II	Recruiting	Combined with cisplatin and gemcitabine	NCT01763788
			II	Recruiting	Combined with carboplatin and paclitaxel	NCT01769391
			II	Recruiting	Combined with cisplatin and gemcitabine	NCT01788566
Nimotuzumab	EGFR	Breast carcinoma	II	Not yet recruiting	Combined with capecitabine and docetaxel	NCT01939054
		Cervical cancer	II	Recruiting	Combined with chemoradiotherapy	NCT01938105
		Gastric cancer	III	Recruiting	Combined with irinotecan	NCT01813253
		NSCLC	I/II	Not yet recruiting	Combined with afatinib	NCT01861223
		Rectal cancer	II	Recruiting	Combined with radiotherapy, capecitabine and oxaliplatin	NCT01899118
Ofatumumab	CD20	Leukemia	II	Not yet recruiting	Combined with cyclophosphamide and fludarabine	NCT01762202
		NHL	I	Recruiting	Combined with rIL-18	NCT01768338
Panitumumab	EGFR	Anal cancer	II	Recruiting	Combined with capecitabine, mitomycin and radiotherapy	NCT01843452
		Bladder cancer	II	Recruiting	Combined with carboplatin and gemcitabine	NCT01916109
Pertuzumab	HER2	Gastric cancer Gastresophageal cancer	III	Recruiting	Combined with capecitabine, cisplatin, 5-FU and trastuzumab	NCT01774786
Rituximab	CD20	B-cell malignancies	I	Recruiting	Combined with a PI3K inhibitor	NCT01905813
		Hodgkin's lymphoma	0	Not yet recruiting	Combined with brentuximab vedotin	NCT01900496
		Neuroblastoma	III	Recruiting	Combined with dexamethasone	NCT01868269
		Prostate cancer	0	Recruiting	As single agent	NCT01804712
SAR650984	CD38	MM	I	Recruiting	Combined with lenalidomide and dexamethasone	NCT01749969
TF2	CEA	Breast cancer	I/II	Recruiting	As single agent	NCT01730612
		Medullary thyroid carcinoma	I/II	Recruiting	As single agent	NCT01730638
Trastuzumab	HER2	Bladder cancer	II	Active, not recruiting	Combined with carboplatin, cisplatin and gemcitabine	NCT01828736
		Recurrent or metastatic tumors	II	Recruiting	Combined with lapatinib	NCT01771458

Abbreviations: 5-FU, 5-fluorouracil; AML, acute myeloid leukemia; ASCT, autologous stem cell transplantation; BEAM, carmustine + etoposide + cytarabine + melphalan; CEA, carcinoembryonic antigen; DLBCL, diffuse large B-cell lymphoma; EGFR, epidermal growth factor receptor; EPCAM, epithelial cell adhesion molecule; IL, interleukin; mAb, monoclonal antibody; MM, multiple myeloma; n.a., not available; NHL, non-Hodgkin's lymphoma; NSCLC, non-small cell lung carcinoma; PI3K, phosphoinositide-3-kinase; PLD, pegylated liposomal doxorubicin; r, recombinant; RANKL, receptor activator of NF-κB ligand; TRAILR2, TNFα-related apoptosis-inducing ligand receptor 2; VEGF, vascular endothelial growth factor. *between 2012, October 1st and the day of submission. **refers to hitherto investigational tumor-targeting mAbs as well as to FDA-approved tumor-targeting mAbs employed as off-label interventions.

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