Table 1.
MDM2 inhibitors in clinical trials.
| Drug name | Clinical Trials identifier *completed | Tumour | Combination treatment | Phase | Response rate(Completed trials only) | Reported grade 3/4 toxicities (Completed trials only) |
|---|---|---|---|---|---|---|
| RG7112 | NCT00559533* | Advanced solid tumours | 1 | 26.7% SD (sarcoma subgroup) | Diarrhoea, cytopenia, hyponatremia (86) | |
| EudraCT 2009-015522* | Liposarcoma (neoadjuvant) | 2 | 5% PR, 70% SD | Neutropenia, thrombocytopenia | ||
| NCT01605526* | Soft tissue sarcoma | Doxorubicin | 1 | 50% SD (interim evaluation) | Neutropenia (60%), thrombocytopenia (45%), febrile neutropenia (22%) (87) | |
| CGM097 | NCT01760525* | Advanced solid tumours | 1 | 2.1% PR, 43.8% SD | Thrombocytopenia, neutropenia (80) | |
| Idasanutlin | NCT01462175* | Advanced tumours | 1 | 30.6% SD | Nausea/vomiting, diarrhoea, thrombocytopenia, neutropenia, febrile neutropenia | |
| NCT03158389 | Glioblastoma | 1b | ||||
| NCT03555149 | Colorectal Cancer | Atezolizumab | 1b | |||
| CRUKE/12/032 | Prostate cancer | Abiraterone or enzalutamide | 1 | |||
| Siremadlin | NCT02143635* | Advanced solid tumours | 1 | 2% PR, 34% SD | Neutropenia, thrombocytopenia, anaemia (85) | |
| NCT02343172* | Liposarcoma | Ribociclib | 1 | 4% PR, 49% SD | Neutropenia, thrombocytopenia, anaemia (88) | |
| NCT04116541 | Advanced solid tumours | Ribociclib | 2 | |||
| NCT02601378 | Uveal melanoma | LXS196 (PKC inhibitor) | 1 | |||
| NCT03714958 | Colorectal Cancer | Trametinib | 1 | |||
| AMG-232 (KRT-232) | NCT01723020* | Advanced solid tumours | 1 | No objective response. | Thrombocytopenia, neutropenia (89) | |
| NCT03787602 | Merkel cell carcinoma | 2 | ||||
| NCT03107780 | Glioblastoma | 1 | ||||
| MI-77301 | NCT01636479* | Advanced solid tumours | 1 | Best response SD in 56% | Thrombocytopenia, neutropenia (90) | |
| NCT01985191* | Advanced solid tumours | Pimasertib | 1 | 4% PR, 63% SD | Thrombocytopenia, fatigue, elevated creatinine, diarrhoea, elevated lipase/amylase, pneumonitis, decreased ejection fraction (91) | |
| APG-115 | NCT02935907* | Advanced solid tumours | 1 | 21.4% SD after 2 cycles | Fatigue (10.7%), thrombocytopenia (10.7%) (92) | |
| NCT03781986 | Salivary gland carcinoma | +/- Carboplatin | 1b | |||
| BI-907828 | NCT03449381 | Advanced solid tumours | 1 | |||
| NCT03964233 | Advanced solid tumours | BI-754091 (anti-PD1) | 1 | |||
| BI-754111 (anti-LAG3) | ||||||
| Milademetan | JapicCTI-142693* | Advanced solid tumours | 1 | 43.8% SD | Thrombocytopenia, anaemia, hyponatremia, transaminitis, neutropenia (93) | |
| NCT05012397 | Advanced solid tumours | 2 | ||||
| ALRN-6924 | NCT03725436 | Advanced solid tumours | Paclitaxel | 1 |
*completed.