Table 1.
Tumor necrosis factor super family (TNF-SF) agonistic monospecific antibodies in clinical studies (www.clinicaltrials.gov)
| Target | Name | Format | Tumor type | Combination | Phase | Status | Clinical ID | Information by |
|---|---|---|---|---|---|---|---|---|
| 4-1BB |
Urelumab (BMS-663513) |
huIgG4 | Melanoma | – | II |
Completed (10/2009) |
NCT00612664 | Bristol-Myers Squibb |
| Urothelial carcinoma/bladder cancer | Nivolumab (αPD-1) | II | Recruiting | NCT02845323 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||
|
Utomilumab (PF-05082566) |
huIgG2 | Adv. solid tumors | Pembrolizumab (αPD-1) | I |
Completed (02/217) |
NCT02179918 | Pfizer | |
| Solid tumor/B-cell lymphoma | Rituximab (αCD20) | I |
Completed (02/2019) |
NCT01307267 | Pfizer | |||
| Her2-positive breast cancer | Trastuzumab (αHer-2)/Trastuzumab Emtansine (αHer2-ADC) | I | Active | NCT03364348 | George W. Sledge Jr., Stanford University | |||
| Adv. cancers | Avelumab (αPD-L1)/CMP-001 (TLR9 agonist)/PF-04518600 (αOX40) | II | Active | NCT02554812 | Pfizer | |||
| YH004 | huIgG1 | Cancer | – | I | Recruiting | NCT05040932 | Eucure (Beijing) Biopharma Co., Ltd. | |
| ATOR-1017 | huIgG4 | Solid tumor | – | I | Recruiting | NCT04144842 | Alligator Bioscience AB | |
| EU101 | n.i.a. | Solid tumor | – | I/II | Recruiting | NCT04903873 | Eutilex | |
| ADG106 | huIgG4 | Metastatic NSCLC | Nivolumab (αPD-1) | I/II | Recruiting | NCT05236608 | National University Hospital, Singapore | |
| AGEN2372 | huIgG4 | Adv. solid tumor | AGEN1181 (αCTLA-4) | I | Recruiting | NCT04121676 | Agenus Inc. | |
| LVGN6051 | huIgG (huFcγRIIB selective) | Soft tissue sarcoma | Anlotinib | I/II | Not yet recruiting | NCT05301764 | Lyvgen Biopharma Holdings Limited | |
| OX40 | MOXR0916 | huIgG1 | Adv. or metastatic solid tumors | Atezolizumab (αPD-L1) | I |
Completed (11/2019) |
NCT02410512 | Genentech, Inc. |
| PF-04518600 | huIgG2 | Adv. or metastatic carcinoma | PF-05082566 (α4-1BB) | I |
Completed (11/2020) |
NCT02315066 | Pfizer | |
| Adv. malignancies | Avelumab (αPD-L1)/Utomilumab (α4-1BB)/radiation therapy | I/II | Active | NCT03217747 | M.D. Anderson Cancer Center | |||
| Adv. malignancies | Avelumab (αPD-L1)/Utomilumab(α4-1BB)/CMP-001 (TLR9 agonist)/PD 0360324 (Anti-M-CSF) | II | Active | NCT02554812 | Pfizer | |||
| Recurrent/refractory acute myeloid leukemia | Avelumab (αPD-L1)/Azacitidine | I/II | Active | NCT03390296 | M.D. Anderson Cancer Center | |||
| Follicular Lymphoma | Rituximab (αCD20)/Utomilumab (α4-1BB) | I | Active | NCT03636503 | Caron A. Jacobson, Dana-Farber Cancer Institute | |||
| Triple negative breast cancer | Avelumab (αPD-L1) | II | Recruiting | NCT03971409 | Hope Rugo, MD, University of California, San Francisco | |||
| Metastatic kidney cancer | Axitinib | II | Recruiting | NCT03092856 | University of Southern California | |||
| MEDI6469 | mIgG1 | Metastatic breast cancer | – | I |
Completed (08/2018) |
NCT01862900 | Providence Health & Services | |
| Head and neck cancer | – | I | Active | NCT02274155 | Providence Health & Services | |||
| MEDI0562 | huIgG | Adv. solid tumors | – | I |
Completed (01/2018) |
NCT02318394 | MedImmune LLC | |
| Ovarian cancer | Durvalumab (αPD-1), Tremelilumab (αCTLA-4), MEDI 9447 (αCD73) | II |
Completed (09/2021) |
NCT03267589 | Nordic Society of Gynaecological Oncology - Clinical Trials Unit | |||
| Adv. solid tumors | Durvalumab (αPD-1)/Tremelimumab (αCTLA-4) | I |
Completed (08/2019) |
NCT02705482 | MedImmune LLC | |||
| Head and neck squamous cell carcinoma or melanoma | – | I | Active | NCT03336606 | Providence Health & Services | |||
| BMS-986178 | huIgG1 | Adv. solid tumors | Nivolumab (αPD-1)/Ipilimumab (αCTLA-4) | I/II |
Completed (11/2020) |
NCT02737475 | Bristol-Myers Squibb | |
| Adv. or metastatic solid tumors | SD-101 (TLR9 agonist) | I | Active | NCT03831295 | Ronald Levy, Stanford University | |||
| Low-grade B-cell non-Hodgkin lymphomas | Radiation/SD-101 (TLR9 agonist) | I | Active | NCT03410901 | Ronald Levy, Stanford University | |||
| INCAGN01949 | huIgG1 | Adv. or metastatic solid tumors | – | I/II |
Completed (03/2019) |
NCT02923349 | Incyte Corporation | |
| Adv. malignancies | Nivolumab (αPD-1)/Ipilimumab (αCTLA-4) | I/II |
Completed (09/2019) |
NCT03241173 | Incyte Corporation | |||
| Pancreatic cancer and others | CMP-001 (TLR9 agonist) | I/II | Recruiting | NCT04387071 | University of Southern California | |||
| IBI101 | huIgG1 | Adv. solid tumors | Sintilimab (αPD-1) | I | Active | NCT03758001 | Innovent Biologics (Suzhou) Co. Ltd. | |
| HFB301001 | huIgG1 | Adv. solid tumors | – | I | Recruiting | NCT05229601 | HiFiBiO Therapeutics | |
| ES102/INBRX-106 | sdAb3Fc | Adv. solid tumors | – | I | Recruiting | NCT04730843 | Elpiscience Biopharma. Ltd. | |
| Adv. solid tumors | Toripalimab (αPD-1) | I | Recruiting | NCT04991506 | Elpiscience Biopharma. Ltd. | |||
| Adv. or metastatic solid tumors | Pembrolizumab (αPD-1) | I | Recruiting | NCT04198766 | Inhibrx, Inc. | |||
| BGB-A445 | n.i.a. | Adv. solid tumors | Tislelizumab (αPD-1) | I | Recruiting | NCT04215978 | BeiGene | |
| BAT6026 | n.i.a. | Adv. solid tumors | - | I | Recruiting | NCT05105971 | Bio-Thera Solutions | |
| Adv. solid tumors | BAT1308 (αPD-1) | I | Not yet recruiting | NCT05109650 | Bio-Thera Solutions | |||
| GITR | MK-4166 | huIgG1 | Solid tumors | Pembrolizumab (αPD-1) | I |
Completed (07/2019) |
NCT02132754 | Merck Sharp & Dohme LLC |
| TRX518 | huIgG1 | Melanoma/solid tumors | – | I |
Completed (09/2018) |
NCT01239134 | Leap Therapeutics, Inc. | |
| GWN323 | IgG1 | Solid tumors/lymphomas | PDR001 (αPD-1) | I |
Completed (03/2020) |
NCT02740270 | Novartis | |
| INCAGN01876 | huIgG1 | Adv. or metastatic solid tumors | – | I/II |
Completed (12/2019) |
NCT02697591 | Incyte Corporation | |
| Adv. or metastatic malignancies | Ipilimumab (αCTLA-4)/Nivolumab (αPD-1) | I/II |
Completed (11/2021) |
NCT03126110 | Incyte Corporation | |||
| Glioblastoma | INCMGA00012 (αPD-1)/Stereotactic Radiosurgery | II | Active | NCT04225039 | University of Pennsylvania | |||
| ASP1951 | tetravalent huIgG4 | Adv. solid tumors | Pembrolizumab (αPD-1) | I | Active | NCT03799003 | Astellas Pharma Inc | |
| REGN6569 | n.i.a. | Squamous cell carcinoma of head and neck | Cemiplimab (αPD-1) | I | Recruiting | NCT04465487 | Regeneron Pharmaceuticals | |
| BMS-986156 | huIgG1 | Metastatic lung/chest/liver tumors | Ipilimumab (αCTLA-4)/Nivolumab (αPD-1)/radiation | I/II | Recruiting | NCT04021043 | M.D. Anderson Cancer Center |
n.i.a. no information available, adv. advanced