Table 2 List of MDM2-p53 inhibitors in ongoing clinical trials
Drug | Disease | Combination with | Â | Phase | Status | Trial nr | Sponzor | Start date |
|---|---|---|---|---|---|---|---|---|
Idasanutlin (RG7388) | Breast cancer | Atezolizumab | Anti-PD-L1 | I/II | Active, not recruiting | NCT03566485 | Vanderbilt-Ingram Cancer Center | 2018 |
| Â | Acute myelogenous leukemia (AML), acute lymphocytic leukemia, neuroblastoma, solid tumors | Cyclophosphamide Topotecan Fludarabine Cytarabine | Â | I/II | Recruiting | NCT04029688 | Hoffmann-La Roche | 2020 |
| Â | Relapsed multiple myeloma | Ixazomib Dexamethasone Venetoclax | Â | I/II | Active, not recruiting | NCT02633059 | Mayo Clinic | 2021 |
AMG-232Â (KRT-232) | Acute myelogenous leukemia, relapsed and refractory AML | Decitabine | DNA damage | I | Recruiting | NCT03041688 | National Cancer Institute | 2017 |
| Â | Soft tissue sarcoma | Radiation therapy | Â | Ib | Recruiting | NCT03217266 | National Cancer Institute | 2017 |
| Â | Polycythemia vera | Ruxolitinib | TK inhibitor | II | Active, not recruiting | NCT03669965 | Kartos Therapeutics, Inc | 2018 |
| Â | Relapsed multiple myeloma | Carfilzomib Dexamethasone Lenalidomide | Proteosome inhibitor Chemotherapy Chemotherapy | I | Recruiting | NCT03031730 | National Cancer Institute | 2017 |
| Â | Brain cancer | Radiation therapy | Â | I | Recruiting | NCT03107780 | National Cancer Institute | 2018 |
| Â | Acute myelogenous leukemia | Cytarabine Idarubicin HCl | DNA damage DNA damage | Ib | Recruiting | NCT04190550 | National Cancer Institute | 2020 |
APG-115Â (AA-115) | Metastatic melanomas, advanced solid tumors | Pembrolizumab | Anti-PD-1 | Ib/II | Recruiting | NCT03611868 | Ascentage Pharma Group, Inc. | 2018 |
| Â | Salivary gland carcinoma | Carboplatin | DNA damage | I/II | Recruiting | NCT03781986 | Ascentage Pharma Group, Inc. | 2019 |
| Â | Acute myelogenous leukemia (AML), acute lymphocytic leukemia, neuroblastoma | Azacitidine Cytarabine | DNA damage DNA damage | Ib | Recruiting | NCT04275518 | Ascentage Pharma Group, Inc. | 2020 |
| Â | Acute myelogenous leukemia | 5-azacitidine | DNA damage | Ib/II | Recruiting | NCT04358393 | Ascentage Pharma Group, Inc. | 2020 |
| Â | Liposarcoma, advanced solid tumors | Toripalimab | Anti-PD-1 | Ib/II | Not yet recruiting | NCT04785196 | Ascentage Pharma Group, Inc. | 2021 |
| Â | T-prolymphocytic leukemia | APG-2575 | Â | IIa | Not yet recruiting | NCT04496349 | Ascentage Pharma Group, Inc. | 2021 |
BI907828 | Solid tumors | Â | Â | Ia/Ib | Recruiting | NCT03449381 | Boehringer Ingelheim | 2018 |
| Â | Solid tumors | Ezanbenlimab BI754111 | Anti-PD-1 Anti-LAG-3 | Ia/Ib | Recruiting | NCT03964233 | Boehringer Ingelheim | 2019 |
HDM201 (Siremadlin) | Uveal melanoma | LXS196 | PKC inhibitor | I | Recruiting | NCT02601378 | Novartis Pharmaceuticals | 2016 |
| Â | Advanced/metastatic colorectal cancer | Trametinib | MEK inhibitor | I | Recruiting | NCT03714958 | Centre Leon Berard | 2018 |
| Â | Myelofibrosis | Ruxolitinib | TK inhibitor | I/II | Recruiting | NCT04097821 | Novartis Pharmaceuticals | 2019 |
| Â | Range of cancers | Spartalizumab | Anti-PD-1 | I | Recruiting | NCT02890069 | Novartis Pharmaceuticals | 2016 |
| Â | Malignant solid tumors | Ribociclib | CDK inhibitor | II | Recruiting | NCT04116541 | Centre Leon Berard | 2020 |
| Â | Acute myelogenous leukemia | Midostaurin | TK inhibitor | I | Recruiting | NCT04496999 | University Hospital Inselspital, Berne | 2020 |
| Â | Acute myelogenous leukemia, myelodysplastic syndromes | MBG453 (Sabatolimab) Venetoclax | Anti-Tim3 BCL-2 inhibitor | Ib | Recruiting | NCT03940352 | Novartis Pharmaceuticals | 2021 |
DS-3032b (Milademetan) | Acute myelogenous leukemia, relapsed and refractory AML | Cytarabine Venetoclax | DNA damage BCL-2 inhibitor | I/II | Recruiting | NCT03634228 | M.D. Anderson Cancer Center | 2018 |
ALRN-6924 | Pediatric cancer | Cytarabine | DNA damage | I | Recruiting | NCT03654716 | Dana-Farber Cancer Institute | 2018 |
| Â | Small cell lung cancer | Topotecan | Â | Ib/II | Recruiting | NCT04022876 | Aileron Therapeutics | 2019 |
| Â | Breast cancer, malignant solid neoplasm | Paclitaxel | Â | Ib | Recruiting | NCT03725436 | M.D. Anderson Cancer Center | 2019 |