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 |