Table 1 List of MDM2-p53 inhibitors in completed clinical trials
Drug | Disease | Combination with | Action | Phase | Status | Trial nr | Sponzor | Time |
|---|---|---|---|---|---|---|---|---|
RG7112 (RO5045337) | Advanced solid tumors |  |  | I | Completed | NCT00559533* | Hoffmann-LaRoche | 2007–2012 |
|  | Hematologic neoplasm |  |  | I | Completed | NCT00623870* | Hoffmann-La Roche | 2008–2012 |
|  | Solid tumors |  |  | I | Completed | NCT01164033* | Hoffmann-La Roche | 2010–2013 |
|  | Sarcoma | Doxorubicin | DNA damage | Ib | Completed | NCT01605526* | Hoffmann-La Roche | 2012–2013 |
|  | Acute myelogenous leukemia (AML) | Cytarabine | DNA damage | Ib | Completed | NCT01635296* | Hoffmann-La Roche | 2012–2013 |
|  | Extension study of studies marked with* |  |  | I | Completed | NCT01677780 | Hoffmann-La Roche | 2012–2017 |
Idasanutlin (RG7388) | Advanced malignancies, except leukemia |  |  | I | Completed | NCT01462175 | Hoffmann-La Roche | 2011–2014 |
|  | Solid tumors |  |  | I | Completed | NCT03362723 | Hoffmann-La Roche | 2017–2019 |
|  | Acute myelogenous leukemia | Idarubicin Daunorubicin Cytarabine | DNA damage DNA damage DNA damage | I/Ib | Completed | NCT01773408 | Hoffmann-La Roche | 2013–2016 |
|  | Relapsed and refractory AML | Cytarabine | DNA damage | III | Terminated | NCT02545283 | Hoffmann-La Roche | 2012–2020 |
|  | Non-Hodgkin’s lymphoma | Obinutuzumab Rituximab | Anti-CD20 Anti-CD20 | I/Ib | Terminated | NCT02624986 | Hoffmann-La Roche | 2015–2019 |
|  | Relapsed and refractory AML | Venetoclax | BCL-2 inhibitor | Ib | Completed | NCT02670044 | Hoffmann-La Roche | 2016–2020 |
|  | Relapsed and refractory follicular lymphoma, relapsed and refractory diffuse large B-cell lymphoma | Obinutuzumab Venetoclax Rituximab | Anti-CD20 BCL-2 inhibitor Anti-CD20 | Ib/II | Terminated | NCT03135262 | Hoffmann-La Roche | 2018–2020 |
|  | Acute myelogenous leukemia | Cytarabine Daunorubicin | DNA damage DNA damage | Ib/II | Completed | NCT03850535 | Hoffmann-La Roche | 2019–2020 |
AMG-232 (KRT-232) | Advanced solid tumors, multiple myeloma |  |  | I | Completed | NCT01723020 | Amgen | 2012–2017 |
|  | Acute myelogenous leukemia | Trametinib | MEK inhibitor | I | Completed | NCT02016729 | Kartos Therapeutics, Inc. | 2014–2017 |
|  | Metastatic melanoma | Trametinib Dabrafenib | MEK inhibitor BRAF inhibitor | Ib/IIa | Completed | NCT02110355 | Kartos Therapeutics, Inc. | 2014–2018 |
APG-115 (AA-115) | Advanced solid tumors. Lymphomas |  |  | I | Completed | NCT02935907 | Ascentage Pharma Group, Inc. | 2016–2019 |
CGM097 | Advanced solid tumors with TP53wt |  |  | I | Completed | NCT01760525 | Novartis Pharmaceuticals | 2013–2019 |
HDM201 | Liposarcoma | Ribociclib | CDKinhibitor | Ib/II | Completed | NCT02343172 | Novartis Pharmaceuticals | 2015–2019 |
DS-3032b (Milademetan) | Advanced solid tumors, lymphomas |  |  | I | Completed | NCT01877382 | Daiichi Sankyo Co., Ltd. | 2013–2020 |
|  | Relapsed and refractory AML |  |  | I | Completed | NCT03671564 | Daiichi Sankyo Co., Ltd. | 2018–2019 |
|  | Acute myelogenous leukemia | Quizartinib | Tyrosine kinase inhibitor | I | Terminated | NCT03552029 | Daiichi Sankyo Co., Ltd. | 2018–2021 |
|  | Acute myelogenous leukemia, myelodysplastic syndromes | 5-Azacitidine | DNA damage | I | Terminated | NCT02319369 | Daiichi Sankyo Co., Ltd. | 2014–2021 |
ALRN-6924 | Advanced solid tumors, lymphomas |  |  | I/IIa | Completed | NCT02264613 | Aileron Therapeutics | 2014–2020 |
|  | Acute myelogenous leukemia, myelodysplastic syndromes | Cytarabine | DNA damage | I/Ib | Completed | NCT02909972 | Aileron Therapeutics | 2016–2019 |
JNJ-26854165 | Advanced of refractory solid tumors |  |  |  | Completed | NCT00676910 | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 2006–2010 |
SAR405838 | Solid tumors | Pimasertib | MEK inhibitor | I | Completed | NCT01985191 | Sanofi | 2013–2016 |