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. 2021 Nov 5;71(7):1549–1567. doi: 10.1007/s00262-021-03097-x

Table 1.

Clinical trials with B7-H3-targeting immunotherapies

Drug(s) Type of mAb ID Number Phase Recruitment Status Country Estimated enrollment Masking Dose Age (years) Cancer type Outcomes
MGC018 ADC NCT037295961 I/II Recruiting MacroGenics 182 None Not mentioned  > 18 Advanced Solid Tumor, Metastatic Castrate Resistant Prostate Cancer, Non-Small Cell Lung Cancer, Triple Negative Breast Cancer, Squamous Cell Carcinoma of Head and Neck, Melanoma, Prostate Cancer 5/9 metastatic prostate cancer patients with reduction in PSA levels of ≥ 50%, and 3/3 melanoma patients showed partial response with ≥ 24% tumor volume reduction. One patient experienced a grade 4 AE (neutropenia)
MGA271 ADCC NCT013911433 I Terminated United States 179 None 0.01-15 mg/kg  > 18 Melanoma, prostate carcinoma and other B7-H3+ tumors 43.5% of patients (20/46) experienced stable disease (> 12 weeks) and tumor shrinkage (2%-69%), common AEs were observed, including fatigue, nausea, chills, and vomiting
MGA271 ADCC NCT029231804 II Not recruiting United States 33 None 15 mg/kg (weekly) IV  > 18 Prostate Cancer Primary endpoints are safety and tolerability. 3/32 patients showed marked tumor infiltration of CD8 + T cells in MGA271-treated samples
124I-8H9 Radioimmunotherapy NCT0150291717 I Recruiting United States 64 None 0.25–12 mCi 2–21 Brain Cancer, Brain Stem Glioma Some patients presented with grade 3 AEs (hemiplegia, skin infection, and anxiety) but no grade 4 or grade 5 AEs was reported suggesting an acceptable safety profile
131I-8H9 Radioimmunotherapy NCT0008924518 I Not recruiting United States 120 None 10–100 mCi All Brain and Central Nervous System Tumors Neuroblastoma Sarcoma Nearly 50% of patients were alive at 36 months post-treatment in a setting where overall survival at 36 months is usually less than 10%
131I-8H9 Radioimmunotherapy NCT0109964419 I Not recruiting United States 54 None 30–50 mci/m2  > 1 Peritoneal Cancer Three patients (n = 1 each) had transient, self-limiting, possibly therapy-related grade 3 toxicities: neutropenia, hepatic transaminase elevation and thrombocytopenia. 6/7 DSRCT patients treated without evaluable disease remain in remission at a median of 11.1 months post 131I-8H9
DS-7300a ADC NCT041456222 I-II Recruiting United States 160 None Stating at 0.8 mg/kg  > 18 Advanced Solid Tumor, Malignant Solid Tumor Ongoing
MGA271 ADCC NCT029829415 I Completed United States 25 None Starting at 10 mg/kg (weekly) IV 1–35 Neuroblastoma, Rhabdomyosarcoma, Osteosarcoma, Ewing Sarcoma, Wilms Tumor, Desmoplastic Small Round Cell Tumor Ongoing
MGA271 ADCC NCT023813146 I Completed United States 24 None Not mentioned  > 18

Melanoma

Non-Small Cell Lung Cancer

 Ongoing
MGA271 ADCC NCT024752137 I Not recruiting MacroGenics 145 None Not mentioned  > 18

Melanoma

Head and Neck Cancer

Non-Small Cell Lung Cancer

Urethelial Carcinoma

 Ongoing
MGA271 ADCC NCT046348258 II Recruiting United States 80 None Not mentioned  > 18 Head and Neck Cancer Ongoing
DS-5573a ADCP NCT021925679 I Terminated Japan 19 None 0.1–30 mg/kg  > 20 Advanced solid malignant tumor Ongoing
MGD009 BiAb NCT0262853510 I Terminated United States 67 None 0.3 ug/kg (every 2 weeks)  > 18

Mesothelioma, Bladder Cancer,

Melanoma, Squamous Cell Carcinoma of the Head and Neck, Non-Small Cell Lung Cancer, Clear Cell Renal Cell Carcinoma, Ovarian Cancer, Thyroid Cancer, Breast Cancer, Pancreatic Cancer

 Ongoing
4SCAR-276 CAR-T cell NCT0443264911 I-II Recruiting China 100 None Not mentioned 1–75 Solid Tumor Ongoing
SCRICAR-B7H3(s) CAR-T cell NCT0418503812 I Recruiting United States 70 None Not mentioned 1–26

Central Nervous System Tumor, Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, Ependymoma

Medulloblastoma, Germ Cell Tumor, Atypical Teratoid/ Rhabdoid Tumor, Primitive Neuroectodermal Tumor, Choroid Plexus Carcinoma,

Pineoblastoma, Childhood Glioma

 Ongoing
4-1BBζ B7H3-EGFRt-DHFR CAR-T cell NCT0448377813 I Recruiting United States 68 None Not mentioned  < 26 Advanced/metastatic cancer Ongoing
CAR.B7-H3 CAR-T cell NCT0467006814 I Recruiting United States 21 None Not mentioned  > 18 Epithelial Ovarian Cancer Ongoing
B7-H3 CAR-T CAR-T cell NCT0407786615 I/II Recruiting China 40 None Not mentioned 18–75 Recurrent Glioblastoma Refractory Glioblastoma Ongoing
B7-H3 CAR-T CAR-T cell NCT0438517316 I Recruiting China 12 None Not mentioned 18–75 Recurrent Glioblastoma Refractory Glioblastoma Ongoing
131I-8H9 Radioimmunotherapy NCT0327540220 II-III Recruiting Spain 32 None 2 mCi in week 1, 50 mCi in week 2  < 18 Neuroblastoma, CNS Metastases, Leptomeningeal Metastases Ongoing
131I-8H9 Radioimmunotherapy NCT0402221321 II Recruiting United States 55 None 80 mCi/m2  > 1 Desmoplastic Small Round Cell Tumor, Peritoneal Cancer, Peritoneal Carcinoma Ongoing
177Lu-DPTA-omburtamab Radioimmunotherapy NCT0431524622 I-II Not recruiting United States 63 None Dosimetry dose (5 weeks) ITV  > 18 Leptomeningeal Metastasis, Solid Tumor Ongoing
177Lu-DTPA-omburtamab Radioimmunotherapy NCT0416761823 I-II Recruiting United States 40 None Not mentioned 3–19 Medulloblastoma Ongoing