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