Table 1.

Safety and activity data from published studies on ICEs in solid tumors

Drug name	ICE design	Phase	Condition	Number of patients treated	Administration	Toxicity	Objective responses	Reference
Catumaxomab	EpCAMxCD3	I	Solid tumors	16	i.v. (8 h)	Liver toxicity, fatal acute hepatic failure	Not reported	35
Catumaxomab	EpCAMxCD3	I	Lung cancer	21	i.v. (6 h)	Liver toxicity, lymphopenia	Not reported	36
Catumaxomab	EpCAMxCD3	I/II	Epithelial tumors	24	i.p. (3 h)	Liver toxicity, lymphopenia, anemia, pleural empyema	1 CR 4 PR	37
Catumaxomab	EpCAMxCD3	I/II	Colon, gastric, pancreatic cancer	24	i.p. (6 h)	SIRS, pulmonary edema, liver toxicity, lymphopenia	1 CR 3 PR	38
Catumaxomab	EpCAMxCD3	I/II	Ovarian cancer	23	i.p. (6 h)	Liver toxicity, lymphopenia, hypercalcemia	Not reported	39
Catumaxomab	EpCAMxCD3	II	Solid tumors	13	i.p. (6 h)	Transient increases in liver enzymes	Not reported	40
Catumaxomab	EpCAMxCD3	IIa	Ovarian cancer	45	i.p. (6 h)	Anemia, erythema induratum, liver toxicity	1 PR	41
Catumaxomab	EpCAMxCD3	II	Gastric cancer	54	Intraoperative i.p. bolus + i.p. (3 h)	Not applicable	Not reported	42
Catumaxomab	EpCAMxCD3	II	Gastric cancer	64	Intraoperative i.p. bolus + i.p. (3 h)	Hypotension, liver toxicity, SIRS, abdominal pain, hypertension	3 CR 13 PR	43
Catumaxomab	EpCAMxCD3	II	Ovarian cancer	32	i.p. (3 h)	Liver toxicity, dehydration, abdominal pain, chills, fatigue, nausea, vomiting	Not reported	44
Catumaxomab	EpCAMxCD3	II	Ovarian cancer	41	Intraoperative i.p. bolus + i.p. (3 h)	Liver toxicity, pleural effusion, pulmonary embolism	Not reported	45
Catumaxomab	EpCAMxCD3	II/III	Epithelial cancers	258	i.p. (6 h)	Liver toxicity, ileus, gastric hemorrhage, lymphopenia, anemia	Not reported	46
Catumaxomab	EpCAMxCD3	IIIb	Epithelial cancers	219	i.p. (3 h)	Liver toxicity, fatigue, nausea, pyrexia, abdominal pain	Not reported	47
Catumaxomab	EpCAMxCD3 (rechallenge)	I/II	Epithelial cancers	8	i.p. (3 h)	Liver toxicity, fatigue, nausea, pyrexia, abdominal pain	Not reported	48
Solitomab (MT110, AMG110)	EpCAMxCD3	I	Solid tumors	65	i.p. (3 h)	Liver toxicity, diarrhea, lipase increase, peripheral edema	1 PR	49
Ertumaxomab	HER2xCD3	I	Solid tumors	14	i.v. (3 h)	Infusion reaction, CRS, cephalgia, tumor pain, hypertension	1 PR	50
Ertumaxomab	HER2xCD3	I	Breast cancer	17	i.v. (6 h)	Hypotension and ARDS, SIRS, liver toxicity	1 CR 2 PR	51
MDX-H210	HER2xCD64	I	Solid tumors	13	i.v. (2 h)	Fever, chills, rigor	1 PR	52
MDX-H210	HER2xCD64	I	Solid tumors	24	i.v. (2 h)	Neutropenia, thrombocytopenia, monocytopenia	Not reported	53
MDX-H210	HER2xCD64	I	Prostate cancer	7	i.v. (2 h)	Flu-like symptoms, hematological, liver toxicity	Not reported	29
MDX-H210	HER2xCD64	I	Breast cancer	30	i.v. (2 h)	Tumor pain, hypotension, fever, chills, liver toxicity	Not reported	54
MDX-H210	HER2xCD64	I	Breast cancer	23	i.v. (8 h)	Diarrhea, infusion reaction	Not reported	55
MDX-H210	HER2xCD64	Ia/Ib	Breast and ovarian cancer	15	i.v. (2 h)	Hypotension, nausea	2 PR	56
MDX-H210	HER2xCD64	II	Prostate cancer	25	i.v.	Flu-like symptoms, infusion reaction	Not reported	57
2B1	HER2xCD16	I	Solid tumors	15	i.v. (1 h)	Hypotension, leucopenia, thrombocytopenia	1 PR	58
AMG211, MEDI-565	CEAxCD3	I	Gastrointestinal cancer	39	i.v. (3 h)	Hypoxia, diarrhea, CRS, liver toxicity	Not reported	59
RO6958688	CEAxCD3	Ia	Solid tumors	36	i.v.	Infusion reaction, pyrexia, diarrhea, hypoxia, colitis	2 PR	60
RO6958688	CEAxCD3	Ib	Solid tumors	10	i.v.	Infusion reaction, pyrexia, diarrhea, hypoxia, colitis	2 PR	60
Pasotuxizumab, BAY2010112	PSMAxCD3	I	Prostate cancer	16	i.v.	Lymphopenia, infections, CRS, fatigue	1 PR	61

ARDS, acute respiratory distress syndrome; CEA, carcinoembryonic antigen; CR, complete response; CRS, cytokine release syndrome; EpCAM, epithelial cell adhesion molecule; HER2, human epidermal growth factor receptor 2; ICE, immune cell engager; i.p., intraperitoneal; i.v., intravenous; PR, partial response; PSMA, prostate-specific membrane antigen; SIRS, systemic inflammatory response syndrome.